epic3 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals in England Loveday HPa*, Wilson JAa, Pratt RJa, Golsorkhi Ma, Tingle Aa, Bak Aa, Browne Ja, Prieto Jb, Wilcox Mc. a Richard Wells Research Centre, College of Nursing, Midwifery and Healthcare, University of West London (London). b Faculty of Health Sciences, University of Southampton (Southampton). c Microbiology and Infection Control, Leeds Teaching Hospitals and University of Leeds (Leeds).

* Corresponding author: Professor Heather Loveday, Director, Richard Wells Research Centre, College of Nursing, Midwifery and HealthCare, University of West London Paragon House Boston Manor Road Brentford, Middlesex TW8 9GB.

Telephone: +44 (0) 20 8209 4110, email: heather.loveday@uwl.ac.uk Richard Wells Research Centre, University of West London (London) 2013

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SECTION 1 INTRODUCTORY SECTION 1.1 Index Section Section Title Page(s) 1 Introductory Section 2 1.1 Index 2 1.2 1.3 1.4 1.5

Introduction Guideline Development Methodology Consultation Process Glossary

3 5 8 9

2 Standard principles for preventing healthcare-associated infections 19 2.1

in hospital and other acute care settings Introduction

20

2.2 Hospital environmental hygiene 20 2.3 Hand hygiene 27 2.4 The use of personal protective equipment 43 2.5 The safe use and disposal of sharps 51 2.6 Asepsis

57

3 Guidelines for preventing infections associated with the use of short-term urethral catheters

58

3.1 Introduction 59 3.2 3.3

Background and context of the Guidelines Assessing the need for catheterisation

59 62

3.4 Selection of catheter type 64 3.5 Catheter insertion 68 3.6 Catheter maintenance 69 3.7 3.8

Education of healthcare workers and patients System intervention for reducing the risk of infection

74 75

4 Guidelines for preventing infections associated with the use of intravascular access devices

77

4.1 4.2

Introduction What is the evidence for these guidelines?

78 80

4.3 Education of healthcare workers and patients 81 4.4 General asepsis 82 4.5 Selection of catheter type 83 4.6 Selection of catheter insertion site 89 4.7 Maximal sterile barrier precautions during catheter insertion 92 4.8 Cutaneous antisepsis 93 4.9 Catheter and catheter site care 96 4.10 Catheter replacement strategies 99 4.11 General principles for catheter management 102 A Appendices

113

A.1 A.2 A.3 A.4

Guideline Development Team Guideline Advisory Group Consultation Process Standard Principles systematic review process

113 113 114 115

A.5 Short-term indwelling urethral catheters systematic review process 123 A.6 A.7

Intravascular access devices systematic review process Systematic Review Process

125 128

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1. 2 Introduction the epic3 Guidelines 1 2 3 National evidence-based guidelines for preventing healthcare-associated infections 4 (HCAI) in (National Health Service) NHS hospitals were first published in January 5 20011 and updated in 20072. This second updating was commissioned by the 6 Department of Health in 2012 for publication in 2013. 7 8 What are national evidence-based guidelines? 9 These are systematically developed broad statements (principles) of good practice. 10 They are driven by practice need, based on evidence and subject to multi-11 professional debate, timely and frequent review, and modification. National 12 guidelines are intended to inform the development of detailed operational protocols at 13 local level and can be used to ensure that these incorporate the most important 14 principles for preventing HCAI in NHS hospitals and other acute care health services. 15 16 Why do we need national guidelines for preventing healthcare-associated 17 infections? 18 During the past two decades, HCAI have become a significant threat to patient 19 safety. The technological advances made in the treatment of many diseases and 20 disorders are often undermined by the transmission of infections within healthcare 21 settings, particularly those caused by antimicrobial-resistant strains of disease-22 causing microorganisms that are now endemic in many healthcare environments. 23 The financial and personal cost of these infections, in terms of the economic 24 consequences to the NHS and the physical, social and psychological costs to 25 patients and their relatives, have increased both government and public awareness 26 of the risks associated with healthcare interventions, especially that of acquiring a 27 new infection. 28 29 Although not all HCAI can be prevented, many can. Clinical effectiveness, i.e., using 30 prevention measures that are based on reliable evidence of efficacy, is a core 31 component of an effective strategy designed to protect patients from the risk of 32 infection and when combined with quality improvement methods can account for 33 significant reductions in HCAI such as meticillin resistant Staphylococcus aureus and 34 Clostridium difficile. 35 36 What is the purpose of the guidelines? 37 These guidelines describe clinically effective measures that are used by healthcare 38 workers for preventing infections in hospital and other acute care health services. 39 40 What is the scope of the guidelines? 41 Three sets of guidelines were originally developed and have now been updated. 42 They include: 43 Standard infection control principles include best practice recommendations for 44

hospital environmental hygiene, effective hand hygiene, the appropriate use of 45 personal protective equipment, the safe use and disposal of sharps and the 46 principles of asepsis; 47

Guidelines for preventing infections associated with the use of short-term 48 indwelling urethral catheters; and 49

Guidelines for preventing infections associated with the use of intravascular 50 access devices. 51

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What is the evidence for these guidelines? 1 The evidence for these guidelines was identified by multiple systematic reviews of 2 peer-reviewed research. In addition, evidence from expert opinion as reflected in 3 systematically identified professional, national and international guidelines was 4 considered following formal assessment using a validated appraisal tool.2 All 5 evidence was critically appraised for its methodological rigour and clinical practice 6 applicability and the best available evidence influenced the guideline 7 recommendations. 8 9 Who developed these guidelines? 10 A team of specialist infection prevention and control researchers and clinical 11 specialists and a Guideline Development Advisory Group, comprising lay and 12 specialist clinical practitioners developed the epic3 guidelines. (Appendix A1 and A2) 13 14 Who are these guidelines for? 15 These guidelines can be appropriately adapted and used by all hospital practitioners. 16 This will inform the development of more detailed local protocols and ensure that 17 important standard principles for infection prevention are incorporated. 18 Consequently, they are aimed at hospital managers, members of hospital infection 19 prevention and control teams, and individual health care practitioners. At an 20 individual level, they are intended to influence the quality and clinical effectiveness of 21 infection prevention decision-making. The dissemination of these guidelines will also 22 help patients and carers/relatives understand the standard infection prevention 23 precautions they can expect all healthcare workers to implement to protect them from 24 HCAI. 25 26 How are these guidelines structured? 27 Each set of guidelines follows an identical format, which consists of: 28 a brief introduction; 29 the intervention heading; 30 a headline statement describing the key issues being addressed; 31 a synthesis of the related evidence; 32 guideline recommendation(s) classified according to the strength of the 33 underpinning evidence; 34

a bibliography listing the cited evidence. 35 36 How frequently are the guidelines reviewed and updated? 37 A cardinal feature of evidence-based guidelines is that they are subject to timely 38 review in order that new research evidence and technological advances can be 39 identified, appraised and, if shown to be effective in preventing HCAI, incorporated 40 into amended guidelines. The evidence base for these guidelines will be reviewed in 41 two years (2015) and the guidelines will be considered for updating approximately 42 four years after publication (2017). 43 44 How can these guidelines be used to improve your clinical effectiveness? 45 In addition to informing the development of detailed local operational protocols, these 46 guidelines can be used as a benchmark for determining appropriate infection 47 prevention decisions and, as part of reflective practice, to assess clinical 48 effectiveness. They also provide a baseline for clinical audit, evaluation and 49 education, and facilitate ongoing quality improvements. 50 51 How much will it cost to implement these guidelines? 52 Significant additional costs are not anticipated in implementing these guidelines. 53 However, where current equipment or resources do not facilitate the implementation 54

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of the guidelines, or where staff levels of adherence to current guidance are poor, 1 there may be an associated increase in costs. Given the social and economic costs 2 of HCAI, the consequences associated with not implementing these guidelines would 3 be unacceptable to both patients and health care professionals. 4 5 Consultation process 6 These guidelines have been subject to extensive external consultation with key 7 stakeholders, including Royal Colleges, professional societies and organisations, 8 including patients, and trades unions (Appendix A3). 9 10 References 11 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 12

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, Taylor 13 L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based Guidelines for 14 Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing Hospital-acquired 15 Infections. Journal of Hospital Infection 2001; 47(Supplement):S1-S-82. 16

2. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 17 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 18 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 19 20

21 1. 3 Guideline Development Methodology 22 23 24 The guidelines were developed using a systematic review process (Appendix A.4-25 A.6). In each set of guidelines a summary of the relevant guideline development 26 methodology is provided. 27 28 Search Process 29 Electronic databases were searched for national and international guidelines and 30 research studies published during the periods identified for each search question 31 (Appendix A4-A7). A two-stage search process was used. 32 33 Stage 1 Identification of systematic reviews and guidelines 34 For each set of epic guidelines, an electronic search was conducted for systematic 35 reviews of randomised controlled trials and other study designs and current national 36 and international guidelines (Appendix A4-A7). 37 International and national guidelines were retrieved and subjected to critical appraisal 38 using the AGREE II Instrument,1 an evaluation method used internationally for 39 assessing the methodological quality of clinical guidelines. 40 Following appraisal, accepted guidelines were included as part of the evidence base 41 supporting guideline development and where appropriate for delineating search 42 limits. They were also used to verify professional consensus and in some instances, 43 as the primary source of evidence. 44 45 Stage 2 Systematic search for additional evidence 46 Review questions for the systematic reviews of the literature were then developed for 47 each set of epic guidelines following recommendations from expert advisors. 48 Searches were constructed using relevant MeSH (medical subject headings) and 49 free-text terms. On completion of the main search, an economic filter was applied. 50 The following databases were searched: 51

Medline 52 Cumulated Index of Nursing and Allied Health Literature 53

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Embase 1 The Cochrane Library 2 PsycINFO (Only searched for Hand hygiene) 3

4 5 Abstract review identifying studies for appraisal 6

7 printed for review. Titles and abstracts were assessed independently by two 8 reviewers and studies retrieved where the title or abstract: addressed one or more of 9 the review questions; identified primary research or systematically conducted 10 secondary research; indicated a theoretical/clinical/ in use study. Where no abstract 11 was available and the title indicated one or more of the above criteria, the study was 12 retrieved. Due to the limited resources available for this review, foreign language 13 studies were not identified for retrieval. 14 15 Full-text studies were retrieved and read in detail by two experienced reviewers and 16 those meeting study inclusion criteria were independently quality-assessed for 17 inclusion in the systematic review. 18 19 Quality Assessment and Data Extraction 20 Included studies were appraised using tools based on systems developed by the 21 Scottish Intercollegiate Guideline Network (SIGN) for study quality assessment.2 22 Studies were appraised independently by two reviewers and data extracted by one 23 experienced reviewer. Any disagreement between reviewers was resolved through 24 discussion. Evidence tables were constructed from the quality assessments and the 25 studies summarised in adapted considered judgement forms. The evidence was 26 classified using methods from SIGN and adapted to include interrupted time series 27 design and controlled before after studies using criteria developed by the Cochrane 28 Effective Practice and Organisation of Care Group (Table 1).3,4 This system is similar 29 that used in the previous epic and NICE infection prevention guidelines.5,6 30 31 Table 1 - Levels of Evidence for Intervention Studies 3 32 33 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a

very low risk of bias 1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low

risk of bias 1 - Meta-analyses, systematic reviews, or RCTs with a high risk of bias* 2++ High quality systematic reviews of case control or cohort studies.

High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal. Interrupted time series with a control group (i) there is a clearly defined point in time when the intervention occurred and (ii) at least three data points before and three after the intervention.

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal. Controlled before after studies with two or more intervention and control sites.

2 - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal Interrupted time series without a parallel control group (i) there is a clearly defined point in time when the intervention occurred and (ii) at least three data points before and three after the intervention. Controlled before after studies with one intervention and one control site.

3 Non-analytic studies, e.g., uncontrolled before-after studies, case reports,

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case series 4 Expert opinion

Legislation

recommendation 1 The evidence tables and considered judgement reports were presented to the 2 Guideline Development Advisory Group for discussion. Following extensive 3 discussion the guidelines were drafted. 4 5 Factors influencing the guideline recommendations included: 6

the nature of the evidence; 7 the applicability of the evidence to practice; 8 patient preference and acceptability; 9 costs and knowledge of healthcare systems. 10

The classification scheme adopted by SIGN was used to define the strength of 11 recommendation (Table 2). 3,4 12 13 Table 2 - Classification of Recommendations 3 14 15 A At least one meta-analysis, systematic review, or RCT rated as 1++, and

directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+

Good Practice Points

Recommended best practice based on the clinical experience of the guideline development group and patient preference and experience.

IP 3. Recommendation from NICE Interventional Procedures guidance 16

References 17 1. AGREE II Instrument. Appraisal of Guidelines for Research and Evaluation Il. May 2009. 18

Available at: http://www.agreetrust.org/resource-centre/agree-ii/ 19 2. 20

Guidelines Network. November 2011. Available at: 21 http://www.sign.ac.uk/guidelines/fulltext/50/index.html 22

3. NICE. Guideline Development Methods: Information for National Collaborating Centres and 23 Guideline Developers. National Institute for Health and Clinical Excellence February 2004 24 (updated 2005). Available from: www.nice.org.uk (accessed 15 September 2005). 25

4. Harbour R, Miller JA. A new system for grading recommendations in evidence based 26 guidelines. British Medical Journal 2001;323(7308):334-336. 27

5. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox 28 MH. epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated 29 Infections in NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 30

6. Pellowe CM, Pratt RJ, Harper P, Loveday HP, Robinson N, Jones S, MacRae ED, and the 31 Guideline Development Group: Mulhall A, Smith G, Bray J, Carroll A, Chieveley Williams S, 32 Colpman D, Cooper L, McInnes E, McQuarrie I, Newey JA, Peters J, Pratelli N, Richardson 33

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G, Shah PJR, Silk D, Wheatley C. Infection Control: Prevention of healthcare-associated 1 infection in primary and community care. Simultaneously published in: Journal of Hospital 2 Infection December 2003;55(Supplement 2):1-127 and British Journal of Infection Control 3 December 2003 (Supplement):4(6):1-100. Available at: http://www.richardwellsresearch.com 4 5

1. 4 Consultation Process 6 The draft guidelines were circulated to stakeholders for comment (see Appendix A3). 7 The list of stakeholders included all those consulted for the epic2 guidelines and 8 others identified by the Guideline Development Advisory Group and by the DH 9 (England). 10 11 Comments were requested on: 12

the format; 13 the content; 14 practice applicability of the guidelines; 15 patient preference and acceptability 16 specific sections or recommendations. 17

18 All comments received will be collated for consideration by the Guideline 19 Development Advisory Group who will agree any changes to these draft 20 recommendations. 21

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1.5 Glossary 1 2

Acinetobacter An aerobic Gram-negative bacillus commonly isolated from the hospital environment (especially intensive care units) and hospitalised patients; can cause healthcare-associated infections, especially wound infections and pneumonia.

Adenosine triphosphate -

deliver energy

Alcohol handrub A hand decontamination preparation based on alcohol, and for the purposes of this guideline encompasses agents that are either rinses or gels

Antimicrobial A substance that kills or inhibits the growth of microorganisms

Antisepsis The use of chemical or physical methods to prevent infection by destroying or inhibiting the growth of harmful microorganisms

Antiseptic A substance that destroys or inhibits the growth of microorganisms and is sufficiently non-toxic to be applied to skin or mucous membranes

Aseptic non-touch technique (ANTT)

A method used to prevent contamination of susceptible sites by organisms that could cause infection, achieved by ensuring that only sterile equipment and fluids are used and the parts of components that should remain sterile, e.g., the tip of intravenous connectors, are not touched or allowed to come into contact with non sterile surfaces

Bacteraemia Presence of microorganisms in the bloodstream

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Bacteriuria The presence of microorganisms in the urine. If there are no symptoms of infection this is called asymptomatic bacteriuria

Biofilm A colony of bacteria growing that have created themselves by producing exopolymer substances

Bloodstream infection (BSI) The presence of microbes in the blood with significant clinical consequences (e.g. fever, chills, hypotension)

Case-control study

An analytical observational study that aims to investigate the relationship between an exposure or risk factor, e.g., insertion of a central venous catheter, and one or more outcomes, e.g., the occurrence of catheter-related bloodstream infections

Catheter-associated urinary tract infection (CAUTI)

The presence of symptoms or signs attributable to microorganisms that have invaded the urinary tract, where the patient has, or has recently had, a urinary catheter

Catheter colonisation (CLABSI) A significant growth of microorganisms cultured by quantitative or semi-quantitative methods from the tip, subcutaneous segment or hub of the vascular catheter. Catheter colonisation is associated with catheter-related BSI is also known as Central Line-Associated Bloodstream Infection

Catheter related bloodstream infection (CR-BSI)

An infection of the bloodstream where microorganisms are found in a blood culture taken from a peripheral vein of a patient with a CVAD, the patient has clinical signs of infection (e.g. fever, chills, hypotension) and there is no other apparent source for the infection. For surveillance purposes this often refers to BSI that occur in patients with a CVAD and where other possible sources of infection have been excluded. A more rigorous definition is where the same microorganism is cultured from the tip of the catheter as grown from the blood; simultaneous quantitative blood cultures with at least a 5 to 1 ratio of microorganisms cultured

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from the CVAD versus peripheral; differential time to positivity of at least 2 hours for blood cultures cultured peripherally versus from CVAD

Catheter-related infection (CR-infection)

Any infection related to a central venous access device and includes local (e.g. insertion site) and systemic (e.g., bloodstream) infections

Central venous catheter (CVC) A vascular catheter inserted (from a variety of sites) with the tip located in the superior vena cava. CVCs are used for giving multiple infusions, medication or chemotherapy, temporary haemodialysis, monitoring of central venous pressure and frequent blood sampling

Clinical waste

Waste material that consists wholly or partly of human or animal tissue, blood or body fluids, excretions, drugs or other pharmaceutical products, swabs/ dressings, syringes, needles or other sharp instruments

Clostridium difficile A microorganism that can infect the gut and cause disease, e.g., diarrhoea and/or pseudomembranous colitis, especially in patients on antibiotics

Colonisation

Colony-forming unit (CFU)

Microorganisms that establish themselves in a particular environment such as a body surface without producing disease

Colony forming units are a measure of the number of viable cells, capable of producing new colonies when seeded that are contained in a culture.

Cross-over trial A comparison of the outcome between two or more groups of patients that are exposed to different regimens of treatment/intervention where the groups exchange treatment/ intervention after a prearranged period

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Diatheses A tendency to a disease

Disinfection A process that reduces the number of microorganisms to a level at which they are not able to cause harm, but which does not usually destroy spores

Encrustation Urinary proteins, salts and crystals that adhere to the internal and external surface of a urinary catheter

Engineering controls The use of equipment designed to prevent injury to the operator

Exogenous infection Infections caused by microorganisms acquired from another person, animal or the environment. Secondary exogenous infections occur when the microorganisms transferred initially colonises the host and subsequently causes infection

Expert opinion Opinion derived from seminal works and appraised national and international guidelines

Haematogenous seeding Microorganisms causing infection establish infection at another body site as a result of being transferred in the bloodstream

Hand decontamination The process of performing an antiseptic hand rub or antiseptic handwash to remove organic matter and transient microorganisms and reduce the number of resident microorganisms from the hands

Healthcare-associated infection (HCAI)

Infection acquired as a result of the delivery of healthcare either in a acute (hospital) or non-acute setting

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Healthcare worker Any person employed by a health service, social service, local authority or agency to provide care for sick, disabled or elderly people.

High Risk Patients with an increased probability of infection due to their underlying medical condition. Often refers to patients in intensive care units, those receiving total parenteral nutrition, and immunocompromised patients

Hypochlorite A chlorine-based disinfectant

Implantable intravascular devices

A central venous access device that is tunnelled under the skin with a subcutaneous port or reservoir with a self-sealing septum that is accessible by needle puncture through intact skin

Incidence The number of new events (e.g., cases of disease) occurring in a population over defined period of time

Indwelling urethral catheter A catheter inserted into the bladder via the urethra and left in place for a period of time

Infection Microorganisms that have entered the body and are multiplying in the tissues, typically causing specific symptoms

Klebsiella pneumonia Gram-negative bacteria frequently responsible for healthcare associated infections of wound and urinary tract, particularly in immunocompromised patients

Meatus (urethral) External opening of the urethra

MeSH Medical subject heading

Meta-analysis The combination of data from several studies to produce a single estimate of an effect of a

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particular intervention

Meticillin-resistant Staphylococcus aureus (MRSA)

Strains of Staphylococcus aureus that are resistant to many of the antibiotics commonly used to treat infections. Epidemic strains also have a capacity to spread easily from person-to-person

Needle-free devices (also needleless intravascular catheter connectors)

Intravascular connector systems developed to help reduce the incidence of needlestick injury while facilitating medication delivery through intravascular catheters. There are three types of needle-free connectors: blunt cannula (two-piece) systems, one-piece needle-free systems, and one-piece needle-free systems with positive pressure.

Needle safety device (also needle protection/prevention device)

Any device designed to reduce the risk of injury associated with a contaminated needle. This may include needle-free devices or mechanisms on a needle, such as an automated resheathing device, that cover the needle immediately after use

Nitrile A synthetic rubber made from organic compounds and cyanide

Occupational exposure to blood/body fluid

Healthcare worker receives a percutaneous injury (e.g., a needlestick or cut with a sharp object) or contact of mucous membrane or nonintact skin (e.g., exposed skin that is chapped, abraded, or afflicted with dermatitis) with blood, tissue, or other body fluids that are potentially infectious

Outbreak Two or more cases of the same disease where there is evidence of an epidemiological link between them

Particulate filter masks (or respirator masks)

Facemasks which are designed to protect the wearer from inhaling airborne particles including microorganisms. They are made to defined performance standards that include filtration efficiency. To be effective they must be fitted close to the face to minimise leakage

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Percutaneous injury

An injury that results in a sharp instrument/object, e.g., needle, scalpel, cutting or puncturing the skin

Peripheral inserted central venous catheters (PICC)

A vascular catheter inserted into the superior vena cava from the basilic or cephalic vein

Personal protective equipment (PPE)

Specialised clothing or equipment worn to protect against health and safety hazards

Phlebitis Inflammation of the wall of a vein

Post exposure prophylaxis

Drug treatment regimen administered as soon as possible after an occupational exposure to reduce the risk of acquisition of a blood borne virus

Prevalence The number of events (e.g. cases of disease) present in a defined population at one point in time

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Prospective clinical trial Follow-up or longitudinal study where data on exposure is first collected and patients are followed-up for the development of a given condition or outcome, e.g., CR-BSI

Pseudomembranous colitis

Peripheral venous catheter(PVC)

Inflammation of the large intestine (colon) associated with antibiotic use, typically hospital-acquired and most commonly caused by Clostridium difficile. Symptoms include diarrhoea, sometimes bloody, rarely progressing to sepsis and acute abdomen.

A peripheral venous catheter (PVC or peripheral venous line or peripheral venous access catheter) is a catheter (small, flexible tube) placed into a peripheral vein for the safe infusion of medications, hydration fluids, blood products, and nutritional supplements.

Quasi experimental study True experiments involve research designs where a control group is similar to the experimental group in every way except that the control group does not receive the treatment that the experimental group receives. Experimental research most often involves the random assignment of participants to either the experimental or the control group Quasi-experimental research involves research where it is not possible to meet the conditions of true experiments, usually randomisation of participants

Randomised controlled trial (RCT) and non-randomised control trial (NRCT)

A clinical trial where at least two treatment groups are compared, one of them serving as the control group, and treatment allocation is carried out using a random, unbiased method. A non-randomised controlled trial compares a control and treatment group but allocation to each group is not random. Bias is more likely to occur in NRCT

Resident (hand) flora Microorganisms that colonise the deeper crevices of skin and hair follicles as they have adapted to the hospital environment. Not readily transferred to other people or objects, or removed by the mechanical action of soap

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and water. They can be reduced in number with the use of antiseptic soap

Residual effect (handwash agent) A chemical that persists on the skin and continues to kill microorganisms for a period of time

Safe systems of work A set of instructions that defines how to perform a task safely by identifying the risks and the control measures required

Severe acute respiratory syndrome (SARS)

A severe form of pneumonia caused by a coronavirus

Sharps Instruments used in delivering healthcare that can inflict a penetrating injury. Examples include needles, lancets and scalpels

Sharps injury See percutaneous injury

Sterilisation A process that removes or destroys all microorganisms including spores

Surgical masks A mask that covers the mouth and nose to prevent droplets from the wearer being expelled into the environment. As they are also fluid repellent they also provide some protection for the wearer against exposure of mucous membranes to splashes of blood/body fluid

Thrombophlebitis Inflammation of the wall of a vein with secondary thrombosis occurring within the affected segment of vein

Transient (hand) flora Microorganisms acquired on the skin through contact with surfaces. The hostile environment of skin means that they can usually only survive for a short time, but they are readily transferred to other surfaces touched. Can be removed by washing with soap and water

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Urinary tract infection (UTI) The presence of symptoms or signs attributable to microorganisms that have invaded the urinary tract

Vancomycin resistant enterococcus (VRE)

Enterococci are Gram-positive bacteria that are naturally present in the intestinal tract of all people. Vancomycin is an antibiotic to which some strains of enterococci have become resistant. These resistant strains are referred to as VRE and are frequently resistant to other antibiotics generally used to treat enterococcal infections. Serious VRE infections usually occur in hospitalised patients with serious underlying illnesses.

SECTION 2 1 2 STANDARD PRINCIPLES FOR PREVENTING 3 HEALTHCARE-ASSOCIATED INFECTIONS IN 4 HOSPITAL AND OTHER ACUTE CARE SETTINGS 5

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Section 2 - Standard Principles for preventing 1 healthcare-associated infections in hospital and other 2 acute care settings 3

4 2.1 Introduction 5 This guidance is based on the best critically appraised evidence currently available. 6 The type and class of supporting evidence explicitly linked to each recommendation 7 is described. All recommendations are endorsed equally and none is regarded as 8 optional. These recommendations are not detailed procedural protocols and need to 9 be incorporated into local guidelines. 10 11 Standard infection control precautions need to be applied by all healthcare 12 practitioners to the care of all patients, i.e., adults, children and neonates. The 13 recommendations are divided into five distinct interventions: 14 15 1 Hospital environmental hygiene, 16 2 Hand hygiene; 17 3 The use of personal protective equipment; and 18 4 The safe use and disposal of sharps; 19 5 The principles of asepsis. 20 21 These guidelines do not address the additional infection control requirements 22 of specialist settings, such as the operating department or for outbreak 23 situations. 24 25

2.2 Hospital Environmental Hygiene 26 27 28 29 Hospital hygiene is important in preventing HCAI in hospitals 30 This section discusses the evidence upon which recommendations for hospital 31 environmental hygiene are based. Hospital environmental hygiene encompasses a 32 wide range of routine activities. Guidelines are provided here for: 33 34

cleaning the general hospital environment; 35 cleaning items of shared equipment; 36 education and training of staff. 37

38 Maintain a clean hospital environment 39 Current legislation, regulatory frameworks and quality standards emphasise the 40 importance of the healthcare environment and shared clinical equipment being clean 41 and properly decontaminated to minimise the risk of transmission of HCAI and to 42 maintain public confidence.1-5 Research evidence in this field remains largely limited 43 to ecological studies and weak quasi-experimental and observational study designs. 44 45 There is evidence from outbreak reports and observational research that 46 demonstrates the hospital environment becomes contaminated with microorganisms 47 responsible for HCAI. Pathogens may be recovered from a variety of surfaces in 48 clinical environments, including those near to the patient that are frequently touched 49 by healthcare workers.6-15 There is also limited evidence from outbreak reports for an 50 association between contaminated environments and the acquisition of norovirus.16,17 51

21

However, there are few studies that demonstrate the direct transmission of the same 1 strain of microorganism found in the environment to those found in colonised or 2 infected patients. We identified two retrospective cohort studies that demonstrated 3 an increased risk of acquiring healthcare-associated pathogens from a previous 4 occupant of a room. In one study, 11% of 134 patients who acquired Clostridium 5 difficile infection (CDI) were in a room where a prior occupant had CDI, compared to 6 4.6% where there was no prior occupant with CDI (p=0.002). However, the 7 conclusions that can be drawn from this study are limited by the lack of a sensitive 8 test and the lack of screening for asymptomatic carriage or related strains.18 In the 9 second study, patients were significantly more likely to acquire meticillin-resistant 10 Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE) if in a 11 room previously occupied by a carrier of the organism, with odds ratios (OR) of 1.3 12 (95% CI 1.0 to 1.8; p=0.04) and 1.4 (95% CI 1.0 to 1.8; p=0.04), but the effect was 13 not independent of underlying illness or length of prior intensive care unit (ICU) stay, 14 and data on antibiotic exposure was not available.19 15 16 Many microorganisms recovered from the hospital environment do not cause HCAI. 17 Cleaning will not completely eliminate microorganisms from environmental surfaces 18 and reductions in their numbers will be transient.10 There is some evidence that 19 improved cleaning regimens are associated with the control of outbreaks of HCAI.20 20 Disinfectants have been recommended for cleaning of the hospital environment, 21,22 21 however, a systematic review (SR) failed to confirm a link between disinfection and 22 the prevention of HCAI, although contamination of detergent and inadequate 23 disinfection strength could have been an important confounder.23 Often, a range of 24 interventions are introduced in order to control an outbreak and it is difficult to clearly 25 distinguish the effect of a single component, such as cleaning, in these 26 circumstances. 27 28 Enhanced cleaning of single rooms and bed spaces following the transfer or 29 discharge of patients who were colonised or infected with a HCAI, is referred to as 30

We searched for robust evidence from studies conducted in the 31 healthcare environment that demonstrated cleaning interventions that were 32 associated with reductions in both environmental contamination and HCAI. A 33 randomised crossover study24 of daily enhanced cleaning of high touch surfaces in 34 ICU demonstrated a reduction in the daily number of sites in a bed-area 35 contaminated with MRSA (OR 0.59; 95% CI 0.4 to 0.86; p=0.006), and the aerobic 36 colony count in communal areas (OR 0.65; 95% CI 0.47 to 0.92; p=0.013). Although 37 the reduction in MRSA in the environment was associated with a large reduction in 38

p=0.25), there 39 was no effect on the incidence of MRSA acquisition by patients (OR 0.98; 95% CI 40 0.58 to 1.65; p=0.93). 41 42 43 Emerging technology 44 New technologies for cleaning and decontaminating the healthcare environment have 45 become available during the past ten years, including hydrogen peroxide vapour 46 (HPV), and others are in the the early stages of development. However, their 47 effectiveness, cost effectiveness and practicality in terms of reducing HCAI and use 48 in hospitals in the UK has not been demonstrated, as some require the closure of 49 rooms/wards for periods of time to ensure safe and effective use of the technology. 50 51 We identified three studies conducted in patient care environments that provided 52 evidence for the effectiveness of different products on environmental contamination 53 but not reductions in HCAI. A prospective randomised crossover study24 provided 54 evidence for the effectiveness of daily cleaning of high touch surfaces with 55

22

microfiber/copper impregnated cloths on the reduction of MRSA, as discussed 1 above. A randomised controlled trial (RCT) demonstrated the efficacy of daily high 2 touch surface cleaning with peracetic acid on MRSA and C. difficile contamination of 3 the environment, with a significant reduction in MRSA and C. difficile isolated from 4 samples taken from surfaces with gloved hands (p<0.001) and the hands of 5 healthcare workers (3/27 in peractic acid group vs. 15/38 in standard cleaning group; 6 p=0.13).25 Another non-randomised controlled trial (NRCT)26 in two wards at a single 7 hospital, provided evidence that an additional cleaner was associated with a 32.5% 8 reduction in environmental microbial contamination of hand touch sites (95% CI 20.2 9 to 42.9; p<0.0001) and 26.6% reduction in acquisition of MRSA infection (95% CI 7.7 10 to 92.3; p=0.032), although the type of infections were not specified. 11 12 Hydrogen peroxide vapour has been used as a method of enhanced cleaning in 13 situations where wards/beds can be closed or left unused for the required period of 14 time.27,28 We identified a prospective, randomised before-after study29 comparing the 15 efficacy of hypochlorite and a HPV dry-mist system for terminal cleaning of rooms 16 used by a patient with CDI in reducing environmental contamination with C. difficile. 17 Although both methods significantly reduced environmental contamination compared 18 to cleaning alone, HPV achieved a significantly greater reduction (91% vs. 30% 19 decrease in proportion of samples with C. difficile; p<0.005). A prospective cohort 20 study30 provided evidence for the efficacy of HPV when used for terminal 21 decontamination after standard cleaning in significantly reducing acquisition of 22 multidrug resistant organisms, mainly VRE, in patients subsequently admitted to the 23 rooms (adjusted IRR 0.36; 95% CI 0.19 to 0.7). 24 25 The efficacy of antimicrobial surfaces in the clinical environment to reduce surface 26 contamination and HCAI is an area of emerging research. Four non-randomised, 27 experimental studies, conducted in clinical environments, demonstrated significant 28 reductions in microbial burden of between 80 and 90%, on high touch surfaces 29 coated with copper, compared with comparable, non-coated surfaces.31,32 One RCT 30 in an ICU reported a significantly lower acquisition of HCAI in patients allocated to 31 rooms with 6 high touch copper coated surfaces (3.4% vs. 8.1%; p=0.031).35 32 However, this association was not independent of underlying illness, and evidence of 33 poor reliability in detection methods and some between-group contamination 34 undermined the reliability of this evidence. The evidence of the effectiveness and 35 cost-effectiveness of these technologies and their contribution to reductions in HCAI 36 are not currently available. 37 38 Indicators of cleanliness based on levels of microbial or adenosine triphosphate 39 (ATP) contamination have been proposed. However, relationships between ATP and 40 aerobic colony counts are not consistent and neither method distinguishes normal 41 environmental flora and pathogens responsible for HCAI.36,37 Benchmark values of 42 between 250 and 500 relative light units (RLU) have been proposed as a more 43 objective measure of assessing the efficacy of cleaning than visual assessment, 44 although these are based on arbitrary standards of acceptable contamination that 45 have not been shown to be associated with reductions in HCAI.38-40 We identified a 46 number of uncontrolled before-after studies that used ATP in various forms to 47 highlight the extent of contamination of the healthcare environment. In addition, 48 some described the use of ATP monitoring as an intervention to improve cleaning, 49 but the lack of control in the study design precluded their inclusion in this review. 50 Since cleaning will only have a transient effect on the numbers of microorganisms, 51 regular cleaning of hospital surfaces will not guarantee complete elimination. Hand 52 decontamination before every patient contact is therefore required to ensure that 53 pathogens acquired by touch are not transferred to patients. 54 55

23

1 SP1 The hospital environment must be visibly clean, free

from non-essential items and equipment, dust and dirt and acceptable to patients, their visitors and staff. [Revised wording]

Class D/ GPP

SP2 Increased levels of cleaning and disinfection should be

undertaken in outbreaks of infection where the pathogen concerned survives in the environment and environmental contamination may be contributing to spread. [Revised wording]

Class D/ GPP

SP3 The use of chlorine releasing agents and detergent

should be considered in outbreaks of infection where the pathogen concerned survives in the environment and environmental contamination may be contributing to spread. [Revised wording]

Class D /GPP

2 References 3

1. Department of Health. The Health Act 2008: Code of Practice for the Prevention and Control of 4 Health Care Associated Infections. London. Department of Health. p.38. 5

2. Department of Health. Decontamination of Re- Usable Medical Devices in the Primary, 6 Secondary and Tertiary Care Sectors (NHS and Independent providers). 2007. p.1-8 7

3. Care Quality Commission: Guidance about compliance Essential standards of quality and 8 safety. March 2010. Available from: 9 http://www.cqc.org.uk/sites/default/files/media/documents/gac_-_dec_2011_update.pdf 10 (Accessed 19 May 2013). 11

4. National Patient Safety Agency. The national specifications for cleanliness in the NHS: a 12 framework for setting and measuring performance outcomes in ambulance trusts. London: 13 NPSA. 2009. Available from: www.nrls.npsa.nhs.uk/resources/patient-safety-14 topics/environment/ (Accessed 19 May 2013). 15

5. NICE Public Health Guidance 36. Prevention and control of healthcare-associated Infections 16 Quality improvement guide Issued: November 2011. Available from: 17 www.guidance.nice.org.uk/ph36 (Accessed 19 May 2013). 18

6. Boyce JM, Havill NL, Otter JA, Adams NMT. Widespread environmental contamination 19 associated with patients with diarrhea and methicillin  resistant Staphylococcus aureus 20 colonization of the gastrointestinal tract. Infect Control Hosp Epidemiol 2007; 28: 1142-1147. 21

7. Dancer SJ. Importance of the environment in meticillin-resistant Staphylococcus aureus 22 acquisition: the case for hospital cleaning. Lancet Infect Dis 2008; 8: 101-113. 23

8. Griffiths R, Fernandez R, Halcomb E. Reservoirs of MRSA in the acute hospital setting: A 24 systematic review. Contemp Nurse 2002; 13: 38-49. 25

9. Barker J, Vipond IB, Bloomfield SF. Effects of cleaning and disinfection in reducing the spread 26 of Norovirus contamination via environmental surfaces. J Hosp Infect 2004; 58: 42-49. 27

10. Denton M, Wilcox MH, Parnell P, Green D, Keer V, Hawkey PM, Evans I, Murphy P. Role of 28 environmental cleaning in controlling an outbreak of Acinetobacter baumannii on a 29 neurosurgical unit. J Hosp Infect 2004; 56: 106-110. 30

11. Wilcox MH, Fawley WN, Wigglesworth N, Parnell P, Verity P, Freeman J. Comparison of the 31 effect of detergent versus hypochlorite on environmental contamination and incidence of 32 Clostridium difficile infection. J Hosp Infect 2003; 54: 109-114. 33

12. Boyce JM, Potter-Bynoe G, Chenevert C, King T. Environmental contamination due to 34 methicillin-resistant Staphylococcus aureus: possible infection control implications. Infect 35 Control Hosp Epidemiol 1997; 18(9): 622-7. 36

13. Oie S, Hosokawa I, Kamiya A. Contamination of room door handles by methicillin 37 sensitive/methicillin-resistant Staphylococcus aureus. J Hosp Infect 2002; 51: 140-143. 38

14. Schultz M, Gill J, Zubairi S, Huber R, Gordin F. Bacterial contamination of computer keyboards 39 in a teaching hospital. Infect Control Hosp Epidemiol 2003; 24(4): 302-303. 40

15. Brooks SE, Walczak MA, Hameed R. Chlorhexidine resistance in antibiotic resistant bacteria 41 isolated from the surfaces of dispensers of soap containing chlorhexidine. Infect Control Hosp 42 Epidemiol 2002; 23(11): 692-695. 43

24

16. Cheesbrough JS, Green J, Gallimore CI, Wright PA, Brown DW. Widespread environmental 1 contamination with Norwalk-like viruses (NLV) detected in a prolonged hotel outbreak of 2 gastroenteritis. Epidemiol Infect 2000; 125: 93 8. 3

17. Evans MR, Meldrum R, Lane W, Gardner D, Ribeiro CD, Gallimore CI, An outbreak of viral 4 gastroenteritis following environmental contamination at a concert hall. Epidemiol Infect 2002; 5 129: 355 60. 6

18. Shaughnessy MK, Micielli RL, DePestel DD, Arndt J, Strachan CL, Welch KB, Chenoweth CE. 7 Evaluation of hospital room assignment and acquisition of Clostridium difficile infection. Infect 8 Control Hosp Epidemiol 2011 Mar; 32(3): 201-6. 9

19. Datta R, Platt R, Yokoe DS, Huang SS. Environmental cleaning intervention and risk of 10 acquiring multidrug-resistant organisms from prior room occupants. Arch Intern Med 2011 Mar 11 28; 171(6): 491-4. 12

20. Rampling A, Wiseman S, Davis L, Hyett AP, Walbridge AN, Payne, G C, Cornaby, A J. 13 Evidence that hospital hygiene is important in the control of methicillin-resistant 14 Staphylococcus aureus. J Hosp Infect 2001; 49: 109-116. 15

21. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 16 team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 17 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 18 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 19 Hospital-acquired Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 20

22. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox 21 MH. epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated 22 Infections in NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 23

23. Dettenkofer M, Wenzler S, Amthor S, Antes G, Motschall E, Daschner FD. Does disinfection of 24 environmental surfaces influence nosocomial infection rates? A systematic review. Am J Infect 25 Control 2004; 32(2): 84-89. 26

24. Wilson AP, Smyth D, Moore G, Singleton J, Jackson R, Gant V, Jeanes A, Shaw S, James E, 27 Cooper B, Kafatos G, Cookson B, Singer M, Bellingan G. The impact of enhanced cleaning 28 within the intensive care unit on contamination of the near-patient environment with hospital 29 pathogens: a randomized crossover study in critical care units in two hospitals. Crit Care Med 30 2011 Apr; 39(4): 651-8. 31

25. Kundrapu S, Sunkesula V, Jury LA, Sitzlar BM, Donskey CJ. Daily disinfection of high-touch 32 surfaces in isolation rooms to reduce contamination of healthcare workers' hands. Infect 33 Control Hosp Epidemiol 2012 Oct; 33(10): 1039-42. 34

26. Dancer SJ, White LF, Lamb J, Girvan EK, Robertson C. Measuring the effect of enhanced 35 cleaning in a UK hospital: a prospective cross-over study. BMC Medicine 2009, 7: 28. 36

27. French GL, Otter JA, Shannon KP, Adams NMT, Watling D, Parks MJ. Tackling contamination 37 of the hospital environment by methicillin-resistant Staphylococcus aureus (MRSA): a 38 comparison between conventional terminal cleaning and hydrogen peroxide vapour 39 decontamination. J Hosp Infect 2004; 57: 31-37. 40

28. Otter JA Yezli S, Perl TM, Barbut F, French GL The role of no-touch automated room 41 disinfection systems in infection prevention and control. J Hosp Infect 2013; 83: 1-13. 42

29. Barbut F, Menuet D, Verachten M, Girou E. Comparison of the efficacy of a hydrogen peroxide 43 dry-mist disinfection system and sodium hypochlorite solution for eradication of Clostridium 44 difficile spores. Infect Control Hosp Epidemiol 2009 Jun; 30(6): 507-14. 45

30. Passaretti CL, Otter JA, Reich NG, Myers J, Shepard J, Ross T, Carroll KC, Lipsett P, Perl TM. 46 An evaluation of environmental decontamination with hydrogen peroxide vapor for reducing the 47 risk of patient acquisition of multidrug-resistant organisms. Clin Infect Dis 2013 Jan; 56(1): 27-48 35. 49

31. Schmidt MG, Attaway HH, Sharpe PA, John J Jr, Sepkowitz KA, Morgan A, Fairey SE, Singh 50 S, Steed LL, Cantey JR, Freeman KD, Michels HT, Salgado CD. Sustained reduction of 51 microbial burden on common hospital surfaces through introduction of copper. J Clin Microbiol. 52 2012 Jul; 50(7): 2217-23. 53

32. Schmidt MG, Attaway Iii HH, Fairey SE, Steed LL, Michels HT, Salgado CD. Copper 54 continuously limits the concentration of bacteria resident on bed rails within the intensive care 55 unit. Infect Control Hosp Epidemiol. 2013 May; 34(5): 530-3. 56

33. Casey AL, Adams D, Karpanen TJ, Lambert PA, Cookson BD, Nightingale P, Miruszenko L, 57 Shillam R, Christian P, Elliott TS. Role of copper in reducing hospital environment 58 contamination. J Hosp Infect 2010 Jan; 74(1): 72-7. 59

34. Karpanen TJ, Casey AL, Lambert PA, Cookson BD, Nightingale P, Miruszenko L, Elliott TS. 60 The antimicrobial efficacy of copper alloy furnishing in the clinical environment: a crossover 61 study. Infect Control Hosp Epidemiol 2012 Jan; 33(1): 3-9. 62

35. Salgado CD, Sepkowitz KA, John JF, Cantey JR, Attaway HH, Freeman KD, Sharpe PA, 63 Michels HT, Schmidt MG. Copper surfaces reduce the rate of healthcare-acquired infections in 64 the intensive care unit. Infect Control Hosp Epidemiol 2013 May; 34(5): 479-86. 65

36. Mulvey D, Redding P, Robertson C, Woodall C, Kingsmore P, Bedwell D, Dancer SJ. Finding a 66 benchmark for monitoring hospital cleanliness. J Hosp Infect 2011 Jan; 77(1): 25-30. 67

25

37. Boyce JM, Havill NK, , Dumigan DG; Monitoring the Effectiveness of Hospital Cleaning 1 Practices by Use of an Adenosine Triphosphate Bioluminescence Assay infection control and 2 hospital epidemiology Infect Control Hosp Epidemiol 2009 Jul; 30(7): 678-84. 3

38. Lewis T, Griffith C, Gallo M, Weinbren M. A modified ATP benchmark for evaluating the 4 cleaning of some hospital environmental surfaces J Hosp Infect 2008 Jun; 69(2): 156-63. 5

39. Griffith CJ, Obee P, Cooper RA, Burton HF, Lewis M. The effectiveness of existing and 6 modified cleaning regimes in a Welsh hospital. J Hosp Infect 2007; 66: 352-359. 7

40. Malik RE, Cooper RA, Griffith CJ. Use of audit tools to evaluate the efficacy of cleaning 8 systems in hospitals. Am J Infect Control 2003; 31(3): 181-187. 9

10 11 Shared equipment must be decontaminated after use 12 Shared clinical equipment used to deliver care in the clinical environment comes into 13 contact with intact skin and is therefore unlikely to directly introduce infection. 14 However, it can act as a vehicle by which microorganisms are transferred between 15 patients, which may subsequently result in infection. Equipment should therefore be 16 cleaned and decontaminated after each use with cleaning agents compatible with the 17 piece of equipment being cleaned. In some outbreak situations, the use of chlorine-18 releasing agents and detergent should be considered.1-4 19 20 21 SP4 Shared pieces of equipment, used in the delivery of

patient care, must be cleaned and decontaminated after each use with products that are compatible with the equipment. [Revised wording]

Class D/ GPP

22 References 23

1. Department of Health. The Health Act 2008: Code of Practice for the Prevention and Control of 24 Health Care Associated Infections. London. Department of Health. p.38. 25

2. Department of Health. Decontamination of Re- Usable Medical Devices in the Primary, 26 Secondary and Tertiary Care Sectors (NHS and Independent providers). 2007. p.1-8 27

3. Care Quality Commission: Guidance about compliance Essential standards of quality and 28 safety. March 2010. Available from: 29 http://www.cqc.org.uk/sites/default/files/media/documents/gac_-_dec_2011_update.pdf 30 (Accessed 19 May 2013). 31

4. National Patient Safety Agency. The national specifications for cleanliness in the NHS: a 32 framework for setting and measuring performance outcomes in ambulance trusts. London: 33 NPSA. 2009. Available from: www.nrls.npsa.nhs.uk/resources/patient-safety-34 topics/environment/ (Accessed 19 May 2013). 35

36 37

38 39

practices, three studies indicated that staff were not utilising appropriate cleaning 40 practices with sufficient frequency to ensure minimisation of MRSA contamination of 41 personal equipment.1 Staff education was lacking on optimal cleaning practices in the 42 clinical areas. Knowledge deficits may hinder the application of cleaning practices 43 and monitoring and evaluation was indicated. This is further reinforced by an 44 observational study, which noted that lapses in adherence to the cleaning protocol 45 were linked with an increase in environmental contamination with isolates of 46 Acinetobacter baumannii.2 A second SR of four cohort studies comparing the use of 47 detergents and disinfectants on microbial contaminated hospital environmental 48 surfaces, suggested that a lack of effectiveness was, in many instances, due 49 inadequate strengths of disinfectants, probably resulting from a lack of knowledge.3 50 51 We identified no new, robust research studies of education or system interventions 52 for this review. However, creating a culture of responsibility for maintaining a clean 53

26

environment and increasing knowledge about how to decontaminate equipment and 1 high touch surfaces effectively requires education and training of both healthcare 2 cleaning professionals and clinical staff. 3 4 5 SP5 All healthcare workers need to be aware of their

individual responsibility for maintaining a safe care environment for patients and staff and educated about the importance of minimising the opportunities for microbial contamination of the patient environment. Every healthcare worker needs to be clear about their specific responsibilities for cleaning and decontaminating equipment and clinical areas and high touch surfaces close to the patient. [Revised wording]

Class D/ GPP

References 6 1. Boyce JM, Havill NL, Otter JA, Adams NMT. Widespread environmental contamination 7

associated with patients with diarrhea and methicillin   resistant Staphylococcus aureus 8 colonization of the gastrointestinal tract. Infect Control Hosp Epidemiol 2007; 28: 1142-1147. 9

2. Wilcox MH, Fawley WN, Wigglesworth N, Parnell P, Verity P, Freeman J. Comparison of the 10 effect of detergent versus hypochlorite on environmental contamination and incidence of 11 Clostridium difficile infection. J Hosp Infect 2003; 54: 109-114. 12

3. Dettenkofer M, Wenzler S, Amthor S, Antes G, Motschall E, Daschner FD. Does disinfection of 13 environmental surfaces influence nosocomial infection rates? A systematic review. Am J Infect 14 Control 2004; 32(2): 84-89. 15

27

2.3 Hand Hygiene 1

2 3 The following section provides the evidence for recommendations concerning hand 4 hygiene practice. Designing and conducting robust, ethical, randomised controlled 5 trials (RCT) in the field of hand hygiene is challenging, meaning that 6 recommendations in these areas are largely based on evidence from non-7 randomised controlled trials (NRCT), quasi-experimental studies, observational 8 studies and expert opinion derived from systematically retrieved and appraised 9 professional, national and international guidelines. The areas discussed in this 10 section include: 11 12 assessment of the need to decontaminate hands; 13 the efficacy of hand decontamination agents and preparations; 14 the rationale for choice of hand decontamination practice; 15 technique for hand decontamination; 16 care required to protect hands from the adverse effects of hand decontamination 17

practice; 18 promoting adherence to hand hygiene guidelines; 19 involving patients and carers in hand hygiene. 20

21

Why is hand decontamination crucial to the prevention of healthcare-22 associated infection? 23 Cross-transmission is the transfer of organisms between humans. It can occur 24 directly via hands, or indirectly via an environmental source, such as a commode or 25 wash-bowl. It precedes cross-infection and epidemiological evidence indicates that 26 hand-mediated cross-transmission is a major contributing factor in the current 27 infection threats to hospital in-patients.1-3 28

The hands are colonised by two categories of microbial flora. Resident flora is found 29 on the surface and just below the uppermost layer of the skin and generally serves a 30 protective function. These organisms include Staphylococcus epidermidis and 31 coagulase negative staphylococci and are less likely to cause HCAI, but if transferred 32 to susceptible sites such as wounds, may cause infection. Transient flora colonise 33 the surface of the skin and are acquired during contact with the environment and 34 direct contact with the patient. Microorganisms found in transient flora are those 35 more commonly associated with HCAI and include meticillin-sensitive and meticillin-36 resistant Staphylococcus aureus (MSSA/MRSA), multi-resistant Gram-negative 37 organisms, such as Acinetobacter spp, and vancomycin resistant enterococci (VRE). 38 Hand-mediated cross-transmission, from resident and transient skin flora to 39 susceptible sites or devices, such as surgical wounds, endo-tracheal tubes during 40 pulmonary ventilation, intravascular insertion sites, enteral feeding systems or urinary 41 catheter drainage systems, cause life-threatening infections. Cross-transmission to 42 non-vulnerable sites can leave a patient colonised with pathogenic and antibiotic-43 resistant organisms, which may result in a HCAI at some point in the future. 44

Outbreak reports and observational studies of the dynamics of bacterial hand 45 contamination demonstrate an association between patient care activities that involve 46 direct patient contact and hand contamination.2,3,4-6 The association between hand 47 decontamination with a range of hand-wash, and more recently waterless alcohol-48

28

based hand rub (ABHR) preparations and reductions in infection have been 1 confirmed by clinically-based non-randomised trials7,8 and observational studies.9,10 2 3 Current national and international guidance consistently identifies that effective hand 4 decontamination results in significant reductions in the carriage of potential 5 pathogens on the hands and logically decreases the incidence of preventable HCAI, 6 leading to a reduction in patient morbidity and mortality.1, 11 7 8

When must you decontaminate your hands in relation to patient care? 9 Decontamination refers to a process for the physical removal of blood, body fluids, 10 and the removal or destruction of microorganisms from the hands.3 Four key factors 11 influence the need for hand decontamination:2,3 12

the level of the anticipated contact with patients or objects; 13 the extent of the contamination that may occur as a result of that contact; 14 the patient care activities being performed; 15 the susceptibility of the patient. 16

17 Patients are put at risk of developing a HCAI when informal carers or healthcare 18 workers ca19

20 implementation and audit have been widely adopted across the world as a framework 21 for improving hand hygiene compliance among healthcare workers. The five 22 moments are built around accepted hand hygiene practice.3,12 Hands must be 23 decontaminated at critical points before and after patient care activity to prevent 24 cross-transmission.1-3,11 25 26 27 SP6 Hands must be decontaminated:

immediately before each and every episode of direct patient contact;

immediately before an aseptic procedure or handling an invasive device;

immediately after contact with body fluids, mucous membranes and non-intact skin, whether or not gloves have been worn;

between different care activities for the same patient; immediately after the removal of sterile or non-sterile

gloves; immediately after contact with objects and equipment

in the immediate patient environment. [Revised recommendation]

Class C

References 28 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 29

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, Taylor 30 L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based Guidelines for 31 Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing Hospital-acquired 32 Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 33

2. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 34 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS 35 Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 36

3. World Health Organization: WHO Patient Safety. WHO guidelines on hand hygiene in health care. 37 World Health Organization. Geneva: 2009. 38

29

4. Gupta A, Della-Latta P, Todd B, San Gabriel P, Haas J, Wu F, Rubenstien D, Saiman L. Outbreak of 1 extended beta lactamase-producing Klebsiella pneumoniae in a neonatal intensive care unit linked to 2 artificial nails. Infect Cont Hosp Epidemiol 2004; 25(3): 210-215. 3

5. Pittet D, Dharan S, Touveneau S, Sauvan V, Perneger T. Bacterial contamination of the hands of 4 hospital staff during routine patient care. Arch Intern Med 1999; 159(8): 821-826. 5

6. Pessoa-Silva CL, Dharan S, Hugonnet S, , Touveneau S, Posfay-Barbe K, Pfister R, Pittet D. 6 Dynamics of bacterial hand contamination during routine neonatal care. Infect Control Hosp 7 Epidemiol 2004; 25(3): 187-8. 8

7. Fendler EJ, Ali Y, Hammond BS, Lyons MK, Kelley MB, Vowell NA. The impact of alcohol hand 9 sanitizer use on infection rates in an extended care facility. Am J Infect Control 2002; 30(4): 226-233. 10

8. Ryan MAK, Christian RS, Wohlrabe J. Handwashing and respiratory illness among young adults in 11 military training. Am J Prev Med 2001; 21(2): 79-83. 12

9. Pittet D, Hugonnet S, Harbarth S, Mourouga P, Sauvan V, Touveneau S. Effectiveness of a hospital 13 wide programme to improve compliance with hand hygiene. Lancet 2000; 356: 1307-1312. 14

10. Gordin FM, Schulz ME, Huber RA, Gill JA. Reduction in nosocomial transmission of drug resistant 15 bacteria after introduction of an alcohol-based hand rub. Infect Cont Hosp Epidemiol 2005; 26(7): 16 650-653. 17

11. Boyce JM, Pittet D. Guideline for Hand Hygiene in Healthcare Settings: Recommendations of the 18 Healthcare Infection Control Practice Advisory Committee and the HICPAC/SHEA/APIC/IDSA 19 Hygiene Task Force 2002. p.58. 20

12. Sax H, Allegranzi B, Uçkay I, Larson E, Boyce J, Pittet D. 'My five moments for hand hygiene': a 21 user-centred design approach to understand, train, monitor and report hand hygiene. J Hosp Infect 22 2007; 67: 9-21. 23

24

Is any one hand cleaning preparation better than another? 25 Current national and international guidelines1-3 consider the efficacy of various 26 preparations for the decontamination of hands using liquid soap and water, antiseptic 27 hand-wash agents and ABHR in laboratory studies and their effectiveness in clinical 28 use. Overall, there is no compelling evidence to favour the general use of antiseptic 29 hand-washing agents over liquid soap or one antiseptic agent over another.1-5 30 31 Many studies have been conducted during the past 15 years3 comparing hand 32 hygiene preparations, including ABHR and gels, antiseptic hand washes and liquid 33 soap. Randomised controlled trials and other quasi-experimental studies generally 34 demonstrate alcohol-based preparations to be a more effective hand hygiene agent 35 than non-medicated soap and antiseptic hand-washing agents, with a small number 36 of studies demonstrating no statistically significant difference.6-23 Many of these 37 studies involve the use of ABHR as part of a number of interventions or multimodal 38 campaigns to improve hand hygiene practice and have methodological flaws that 39 weaken the causal relationship between the introduction of ABHR and reductions in 40 HCAI.24 41 42 We identified one multivariate, interrupted time series study that suggested that the 43 amount of ABHR used per patient day was the only factor associated with a 44 reduction in MRSA incidence density (p=0.011) in a neonatal intensive care unit in 45 Japan.25 Incidence density fell over a four-year period from an average of 15 per 46 1,000 patient days, with a peak of 20 per 1,000 patient days in August 2006, to 0 per 47 1,000 patient days in October 2008 and sustained to July 2009 (average incidence 48 density 7.5 per 1,000 patient days). The supporting evidence from laboratory studies 49 of the efficacy of ABHR indicates that these products are highly effective at reducing 50 hand carriage, whilst overcoming some of the recognised barriers to hand-washing; 51 most importantly, the ease of use at the point of patient care. 52 53 These studies underpin a continuing trend to adopt ABHR and gels for routine use in 54 clinical practice. However, some studies highlight the need for continued evaluation 55 of the use of ABHR within the clinical environment to ensure staff adherence to 56 guidelines and effective hand decontamination technique.22, 23 57 58

30

Choice of decontamination: is it always necessary to wash hands to achieve 1 decontamination? 2 Choosing the method of hand decontamination will depend upon the assessment of 3 what is appropriate for the episode of care, the available resources, what is 4 practically possible and, to some degree, personal preferences based on the 5 acceptability of preparations or materials. 6 7 In general, effective hand washing with a liquid soap and water or the effective use of 8 ABHR will remove transient microorganisms and render the hands socially clean. 9 The effective use of ABHR will also substantially reduce resident microorganisms. 10 This level of decontamination is sufficient for general social contact and most clinical 11 care activities.1-3 The use of a liquid soap preparation that contains an antiseptic will 12 reduce both transient microorganisms and resident flora and exert a residual effect, 13 which may be required in situations where prolonged reduction in microbial flora on 14 the skin is required e.g. surgery and some invasive procedures. Preparations 15 containing antiseptics are not normally necessary for everyday clinical practice, but 16 may be used in outbreak situations.1-3 17 18 Alcohol-based hand rub is not effective against some microorganisms such as C. 19 difficile, will not remove dirt and organic material and may not be effective in some 20 outbreak situations.26,27 We identified two laboratory studies that demonstrated that 21 ABHR was not effective in removing C. difficile spores from hands.28,29 In the first 22 study, a comparison of liquid soap and water, chlorhexidine gluconate (CHG) soap 23 and water, antiseptic hand wipes and ABHR resulted in all the soap and water 24 protocols yielding greater mean colony forming units (CFU) reductions, followed by 25 the antiseptic hand wipes, than ABHR. Alcohol-based hand rub was equivalent to no 26 intervention (0.06 log10 CFU/mL [95% CI, -0.34 to 0.45 log10 CFU/mL]).28 In the 27 second study, three ABHR preparations with a minimum 60% alcohol concentration 28 were compared with antiseptic (CHG) soap and water. Antiseptic soap and water 29 significantly reduced spore counts, compared with each of the ABHRs (CHG vs. 30 Isagel, p=.005; CHG vs. Endure, p=.010; CHG vs. Purell, p=.005). In addition, 30% 31 or the residual spores were readily transferred by handshake following the use of 32 ABHR.29 Recent evidence from a laboratory study comparing the efficacy of liquid 33 soap and water and ABHR with and without CHG against H1N1 virus, demonstrated 34 that all the hand hygiene protocols were effective in reducing virus copies.30 A further 35 study comparing the use of liquid soap and water and 65% ethanol hand sanitisers 36 for the removal of Rhinovirus, indicated that the hand sanitisers were more effective 37 than soap and water.31 38 39 Two economic evaluations from the USA, included in recent NICE Primary Care 40 guidelines, suggest that non-compliance with hand hygiene guidelines results in 41 increased infection-related costs.32 Although compliance increases procurement 42 costs of hand hygiene products, even a small increase in compliance is likely to 43 result in reduced infection costs. Alcohol-based hand rub is likely to be less costly 44 and result in greater compliance. 45 46 National and international guidelines suggest that the acceptability of agents and 47 techniques is an essential criterion for the selection of preparations for hand 48 hygiene.1,2 Acceptability of preparations is dependent upon the ease with which the 49 preparation can be used in terms of time and access, together with their 50 dermatological effects. Due to their efficacy and ease of use, ABHRs are 51 recommended for routine use and offer a practical and acceptable alternative to hand 52 washing for most clinical activities.2 53

31

SP7 Use an alcohol-based hand rub for routine decontamination of hands during clinical care. [Revised recommendation]

Class A

1 SP8 Use liquid soap and water to decontaminate hands that

are visibly soiled or potentially contaminated with dirt or organic material and following caring for patients with vomiting or diarrhoeal illness, whether or not gloves have been worn. [Revised recommendation]

Class A

SP9 Hands should be washed with soap and water after

several consecutive applications of alcohol-based hand rub. [No change]

Class D/ GPP

References 2 1. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 3

epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 4 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 5

2. Boyce JM, Pittet D. Guideline for Hand Hygiene in Healthcare Settings. recommendations of the 6 Healthcare Infection Control Practice Advisory Committee and the HICPAC/SHEA/APIC/IDSA 7 Hygiene Task Force. 2002. p.58. 8

3. World Health Organization: WHO Patient Safety. WHO guidelines on hand hygiene in health care. 9 World Health Organization. Geneva: 2009. 10

4. Pellowe CM, Pratt RJ, Loveday HP, Harper P, Robinson N, Jones SRLJ. The epic project. Updating 11 the evidence-base for national evidence-based guidelines for preventing healthcare-associated 12 infections in NHS hospitals in England: a report with recommendations. Br J Infect Control 2004; 13 5(6): 10-15. Available at: http://www.richardwellsresearch.com. 14

5. Pellowe CM, Pratt RJ, Harper P, Loveday HP, Robinson N, Jones S, MacRae ED, and the 15 Guideline Development Group. Infection Control: Prevention of healthcare-associated infection in 16 primary and community care. Simultaneously published in: J Hosp Infect December 2003; 17 55(Supplement 2): 1-127 and Br J Infect Control December 2003 (Supplement): 4(6): 1-100. 18 Available at: http://www.richardwellsresearch.com. 19

6. Lucet J-C, Rigaud M-P, Mentre F, Kassis N, Deblangy C, Andremont A Bouvet E. Hand 20 contamination before and after different hand hygiene techniques: a randomised clinical trial. J 21 Hosp Infect 2002; 50: 276-280. 22

7. Winnefeld M, Richard MA, Drancourt M, Grob JJ. Skin tolerance and effectiveness of two hand 23 decontamination procedures in everyday hospital use. Brit J Dermatol 2000; 143: 546-550. 24

8. Larson E, Aiello AE, Bastyr J, Lyle C, Stahl J, Cronquist A. et al. Assessment of two hand hygiene 25 regimens for intensive care unit personnel. Crit Care Med 2001; 29(5): 944-951. 26

9. Girou E, Loyeau S, Legrand P, Oppein F, Brun-Buisson C. Efficacy of handrubbing with alcohol 27 based solution versus standard handwashing with antiseptic soap: randomised clinical trial. Br Med 28 J 2002; 325: 362-365. 29

10. Zaragoza M, Salles M, Gomez J, Bayas JM, Trilla A. Handwashing with soap or alcoholic solutions? 30 A randomized clinical trial of its effectiveness. Am J Infect Control 1999; 27(3): 258-261. 31

11. Larson EL, Cimiotti J, Haas J, Parides M, Nesin M, Della-Latta P, Saiman L. Effect of antiseptic 32 handwashing vs alcohol sanitizer on health care- associated infections in neonatal intensive care 33 units. Arch Pediat Adol Med 2005; 159: 377-383. 34

12. Herruzo-Cabrera R, Garcia-Caballero J, Martin-Moreno JM, Graciani-Perez-Regadera MA, Perez-35 Rodriguez J. Clinical assay of N-duopropenide alcohol solution on hand application in newborn and 36 pediatric intensive care units: Control of an outbreak of multiresistant Klebsiella pneumoniae in a 37 newborn intensive care unit with this measure. Am J Infect Control 2001; 29(3): 162-167. 38

13. Herruzo-Cabrera R, Garcia-Caballero J, Fernandez-Acenero MJ. A new alcohol solution (N-39 duopropenide) for hygienic (or routine) hand disinfection is more useful than classic handwashing: 40 in vitro and in vivo studies in burn and other intensive care units. Burns 2001; 27: 747-752. 41

14. Larson E, Silberger M, Jakob K, Whittier S, Lai L, Latta PD, et al. Assessment of alternative hand 42 hygiene regimens to improve skin health among neonatal intensive care unit nurses. Heart Lung 43 2000; 29(2): 136-142. 44

15. Kramer A, Rudolph P, Kampf G, Pittet D. Limited efficacy of alcohol-based hand gels. Lancet 45 2002;3 59: 1489-1490. 46

32

16. Moadab A, Rupley KF, Wadhams P. Effectiveness of a non-rinse alcohol-free antiseptic hand wash. 1 J Am Podiat Med Assn 2001; 91(6): 288-293. 2

17. Guilhermetti M, Hernandes SED, Fukushigue Y, Garcia LB, Cardoso CL. Effectiveness of hand-3 cleansing agents for removing Methicillin-Resistant Staphylococcus aureus from contaminated 4 hands. Infect Control Hosp Epidemiol 2001; 22(2): 105-108. 5

18. Paulson DS, Fendler EJ, Dolan MJ, Williams RA. A close look at alcohol gel as an antimicrobial 6 sanitizing agent. Am J Infect Control 1999; 27(4): 332-338. 7

19. Cardoso CL, Pereira HH, Zequim JC, Guilhermetti M. Effectiveness of hand-cleansing agents for 8 removing Acinetobacter baumannii strain from contaminated hands. Am J Infect Control 1999; 9 27(4): 327-331. 10

20. Kampf G, Jarosch R, Ruden H. Limited effectiveness of chlorhexidine based hand disinfectants 11 against Methicillin-Resistant Staphylococcus aureus (MRSA). J Hosp Infect 1998; 38: 297-303. 12

21. Dyer DL, Gerenraich KB, Wadhams PS. Testing a new alcohol-free hand santitizer to combat 13 infection. AORN Journal 1998; 68(2): 239-251. 14

22. Dharan S, Hugonnet S, Sax H, Pittet D. Comparison of waterless hand antisepsis agents at short 15 application times: raising the flag of concern. Infect Control Hosp Epidemiol 2003; 24(3): 160-164. 16

23. Sickbert-Bennett EE, Weber DJ, Gergen-Teague MF, Sobsey MD, Samsa GP, Rutala WA. 17 Comparative efficacy of hand hygiene agents in the reduction of bacteria and viruses. Am J Infect 18 Control 2005; 33(2): 67-77. 19

24. Gould DJ, Moralejo D, Drey N, Chudleigh JH. Interventions to improve hand hygiene compliance in 20 patient care. Cochrane Database Syst Rev 2011; 8. 21

25. Sakamoto F, Yamada H, Suzuki C, Sugiura H, Tokuda Y. Increased use of alcohol-based hand 22 sanitizers and successful eradication of methicillin-resistant Staphylococcus aureus from a neonatal 23 intensive care unit: A multivariate time series analysis. Am J Infect Control 2010; 38(7): 529-534. 24

26. Faoagali JL, George N, Fong J, Davy J, Dowser M. Comparison of the antibacterial efficacy of 4% 25 chlorhexidine gluconate and 1% triclosan handwash products in an acute clinical ward. Am J Infect 26 Control 1999; 27(4): 320-326. 27

27. Gordin FM, Schulz ME, Huber RA, Gill JA. Reduction in nosocomial transmission of drug resistant 28 bacteria after introduction of an alcohol-based handrub. Infect Control Hosp Epidemiol 2005; 26(7): 29 650-653. 30

28. Oughton MT, Loo VG, Dendukuri N, Fenn S, Libman MD. Hand hygiene with soap and water is 31 superior to alcohol rub and antiseptic wipes for removal of Clostridium difficile. Infect Control Hosp 32 Epidemiol 2009; 30(10): 939-944. 33

29. Jabbar U, Leischner J, Kasper D, Gerber R, Sambol SP, Parada JP, Johnson S, Gerding DN. 34 Effectiveness of alcohol-based hand rubs for removal of Clostridium difficile spores from hands. 35 Infect Control Hosp Epidemiol 2010; 31(6): 565-570. 36

30. Grayson ML, Melvani S, Druce J, Barr IG, Ballard SA, Johnson PD, Mastorakos T, Birch C. 37 Efficacy of soap and water and alcohol-based hand-rub preparations against live H1N1 influenza 38 virus on the hands of human volunteers. Clin Infect Dis 2009; 48: 285-291. 39

31. Turner RB, Fuls JL, Rodgers ND. Effectiveness of hand sanitizers with and without organic acids for 40 removal of rhinovirus from hands. Antimicrob Agents Ch 2010; 54(3): 1363-1364. 41

32. National Institute for Health and Care Excellence. Partial update of NICE Clinical Guideline 2. 42 Infection: prevention and control of healthcare associated infections in primary and community care. 43 (CG139). London: National Institute for Health and Care Excellence. 44

45

33

Is hand decontamination technique important? 1 Investigations into the technique of hand decontamination are limited in terms of their 2 sample size and observational design. Hand hygiene technique involves both the 3 preparation for and the physical process of decontamination.1-3 Hands and wrists 4 need to be fully exposed to the product being used for hand decontamination and 5 therefore should be free from jewellery and long sleeved clothing. There are a 6 number of small-scale observational studies that have demonstrated that wearing 7 rings and false nails is associated with increased carriage of microorganisms and, in 8 some cases, linked to the carriage of outbreak strains. Department of Health 9 guidance on uniforms and work wear and NICE guidelines indicate that healthcare 10 workers should remove rings and wrist jewellery and wear short sleeves whilst 11 delivering patient care.4,5 12 13 Evidence for the duration of hand hygiene has been considered in previous 14 systematic reviews (SR) underpinning guidelines and suggests that the effect of 15 different durations of hand washing and hand rubbing on bacterial reduction is not 16 significant.6-7 The WHO guidelines indicate that decontamination using ABHR should 17 take 20-30 seconds for a seven-step process and that hand washing should take 40-18 60 seconds for a nine-step process.3 19 20 We identified one recent RCT in a single hospital, which demonstrated that allowing 21 staff to decontamin22 effective as using the WHO seven-step technique, using ABHR or liquid antimicrobial 23 soap and water (p=.04; p<.001, respectively). All three of the protocols tested in this 24 study were effective in reducing hand bacterial load (p<.01).8 A similar result was 25 reported by authors of a laboratory study that tested the EN1500 six-step technique 26 against a range of other protocols. They reported that allowing volunteers to use his 27 or her, -step technique resulted in better 28 coverage of the hands.9 29 30 There have been a number of studies investigating methods of hand drying in the 31 laboratory setting that suggest that there is no significant difference in the efficacy of 32 different methods of drying hands, but that good quality paper towels dry hands 33 efficiently and remove bacteria effectively.10,11 Current guidance on infection control 34 in the built environment suggests that air and jet driers are not appropriate for use in 35 clinical areas.12 We identified one SR of hand drying studies that failed to meet the 36 quality criteria for inclusion.13 37 38 Due to the methodological limitations of studies, evidence recommendations are 39 based on national and international guidelines, which state that the duration of hand 40 decontamination, the exposure of all aspects of the hands and wrists to the 41 preparation being used, the use of vigorous rubbing to create friction, thorough 42 rinsing in the case of hand washing, and ensuring that hands are completely dry are 43 key factors in effective hand hygiene and the maintenance of skin integrity.1-3,5 44 45

SP10 Healthcare workers should ensure that their hands can be decontaminated throughout the duration of clinical work by:

removing all wrist and hand jewellery; wearing short sleeved clothing when delivering

patient care; making sure that fingernails are short and clean,

free from false nails and nail polish;

Class D/ GPP

34

covering cuts and abrasions with waterproof dressings.

[Revised recommendation] SP11 Effective hand washing technique involves three

stages: preparation, washing and rinsing, and drying. Preparation: wet hands under tepid running

water before applying the recommended amount of liquid soap or an antimicrobial preparation.

Washing: the hand wash solution must come into contact with all of the surfaces of the hand. The hands must be rubbed together vigorously for a minimum of 10-15 seconds, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers. Hands should be rinsed thoroughly.

Drying: use good quality paper towels to dry the hands thoroughly.

[No change]

Class D/ GPP

SP12 When decontaminating hands using an alcohol-based

hand rub, hands should be free of dirt and organic material. The hand rub solution must come into contact with all surfaces of the hand. The hands must be rubbed together vigorously, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers, and until the solution has evaporated and the hands are dry. [No change]

Class D/ GPP

1

References 2 1. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 3

epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 4 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 5

2. Boyce JM, Pittet D. Guideline for Hand Hygiene in Healthcare Settings. Recommendations of the 6 Healthcare Infection Control Practice Advisory Committee and the HICPAC/SHEA/APIC/IDSA 7 Hygiene Task Force 2002. p.58. 8

3. World Health Organization: WHO Patient Safety. WHO guidelines on hand hygiene in health care. 9 World Health Organization. Geneva: 2009. 10

4. Department of Health. Uniforms and workwear: Guidance on uniform and workwear policies for 11 NHS employers. 2010. London. Department of Health. P.10. Available at:  12 http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh13 /groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_114754.pdf (Accessed 31 May 14 2013). 15

5. National Institute for Health and Care Excellence. Partial update of NICE Clinical Guideline 2. 16 Infection: prevention and control of healthcare associated infections in primary and community care. 17 (CG139). London: National Institute for Health and Care Excellence. 18

6. Lucet J-C, Rigaud M-P, Mentre F, Kassis N, Deblangy C, Andremont A et al. Hand contamination 19 before and after different hand hygiene techniques: a randomised clinical trial. J Hosp Infect 2002; 20 50: 276-280. 21

7. Sickbert-Bennett EE, Weber DJ, Gergen-Teague MF, Sobsey MD, Samsa GP, Rutala WA. 22 Comparative efficacy of hand hygiene agents in the reduction of bacteria and viruses. Am J Infect 23 Control 2005; 33(2): 67-77. 24

8. Chow A, Arah OA, Chan SP, Poh BF, Krishnan P, Ng WK, Choudhury S, Chan J, Ang B. Alcohol 25 handrubbing and chlorhexidine handwashing protocols for routine hospital practice: A randomized 26 clinical trial of protocol efficacy and time effectiveness. Am J Infect Control 2012; 40: 800-805. 27

9. Kampf G, Reichel M, Feil Y, Eggerstedt S, Kaulfers PM.Influence of rub-in technique on required 28 application time and hand coverage in hygienic hand disinfection. BMC Infect Dis 2008; 8: 149. 29

35

10. Gustafson DR, Vetter EA, Larson DR, Ilstrup DM, Maker MD, Thompson RL, et al. Effects of 4 1 hand-drying methods for removing bacteria from washed hands: A randomised trial. Mayo Clin Proc 2 2000; 75(7): 705-708. 3

11. Yamaoto Y, Kazuhiro U, Takahashi Y. Efficiency of hand drying for removing bacteria from washed 4 hands: comparison of paper towel drying with warm air drying. Infect Control Hosp Epidemiol 2005; 5 26(3): 316-320. 6

12. NHS Estates. HBN 00-09 Infection Control in the Built Environment March 2013. London. 7 Department of Health.p47. Available at: https://www.gov.uk/government/publications/guidance-for-8 infection-control-in-the-built-environment (accessed 31 May 2013). 9

13. Huang C, Ma W, Stack S. The hygienic efficacy of different hand-drying methods: a review of the 10 evidence. Mayo Clin Proc. 2012; 87(8): 791-798. 11 12 13

Does hand decontamination damage skin? 14 Expert opinion concludes that skin damage is generally associated with the detergent 15 base of the preparation and/or poor hand washing technique.1-4 However, the 16 frequent use of some hand hygiene agents may cause damage to the skin and alter 17 normal hand flora. Sore hands are associated with increased colonisation of 18 potentially pathogenic microorganisms and increase the risk of infection.1-4 The irritant 19 and drying effects of liquid soap and antiseptic soap preparations have been 20 identified as one of the reasons why healthcare practitioners fail to adhere to hand 21 hygiene guidelines.1-5 In addition, washing hands regularly with liquid soap and water 22 before or after the use of ABHR is associated with dermatitis and is not necessary.4 23 24 Systematic reviews conducted to underpin national guidelines1-4,6,7 identify a range of 25 studies that compare the use of alcohol-based preparations with liquid soap and 26 water using self-assessment of skin condition by nurses. These studies indicate that 27 ABHR is associated with less skin irritation than liquid soap and water.8-14 In addition, 28 a longitudinal study of the introduction and subsequent use of ABHR over a seven 29 year period observed no reports of irritant and contact dermatitis associated with the 30 use of ABHR.15 31 32 We identified a recent study by the same group, which suggests that two ABHR 33 preparations containing a glycerol emollient are more acceptable to staff (p<.001).16 34 Hand lotions may be become contaminated and have been reported to be associated 35 with an outbreak of infection in a neonatal unit.4 36 37 Current national and international guidance suggests that skin care, through the 38 appropriate use of hand lotion or moisturisers added to hand hygiene preparations, is 39 an important factor in maintaining skin integrity, encouraging adherence to hand 40 decontamination practices and assuring the health and safety of healthcare 41 practitioners.2-4 42 43 44 SP13 Clinical staff should be aware of the potentially

damaging effects of hand decontamination products and encouraged to use an emollient hand cream regularly, for example, after washing hands before a break or going off duty and when off duty, to maintain the integrity of the skin. [No change]

Class D/ GPP

SP14 Consult the occupational health team if a particular

soap, antiseptic hand wash or alcohol-based hand rub causes skin irritation. [Revised wording]

Class D/ GPP

36

References 1 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 2

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 3 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 4 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 5 Hospital-acquired Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 6

2. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 7 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 8 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 9

3. Boyce JM, Pittet D. Guideline for Hand Hygiene in Healthcare Settings. Recommendations of the 10 Healthcare Infection Control Practice Advisory Committee and the HICPAC/SHEA/APIC/IDSA 11 Hygiene Task Force 2002. p.58. 12

4. World Health Organization: WHO Patient Safety. WHO guidelines on hand hygiene in health care. 13 World Health Organization. Geneva: 2009. 14

5. Pietsch H. Hand antiseptics: rubs versus scrubs, alcohol solutions versus alcoholic gels. J Hosp 15 Infect 2001; 48(Supplement A): S33-S36. 16

6. Pellowe CM, Pratt RJ, Harper P, Loveday HP, Robinson N, Jones S, MacRae ED, and the 17 Guideline Development Group. Infection Control: Prevention of healthcare-associated infection in 18 primary and community care. Simultaneously published in: J Hosp Infect December 2003; 19 55(Supplement 2): 1-127 and Br J Infect Control December 2003 (Supplement): 4(6): 1-100. 20

7. Pellowe CM, Pratt RJ, Loveday HP, Harper P, Robinson N, Jones SRLJ. The epic project. Updating 21 the evidence-base for national evidence-based guidelines for preventing healthcare-associated 22 infections in NHS hospitals in England: a report with recommendations. Br J Infect Control 2004; 23 5(6): 10-15. 24

8. Winnefeld M, Richard MA, Drancourt M, Grob JJ. Skin tolerance and effectiveness of two hand 25 decontamination procedures in everyday hospital use. Brit J Dermatol 2000; 143: 546-550. 26

9. Boyce JM, Kelliher S, Vallande N. Skin irritation and dryness associated with two hand-hygiene 27 regimens: Soap-and-water hand washing versus hand antisepsis with an alcoholic hand gel. Infect 28 Control Hosp Epidemiol 2000; 21(7): 442-448. 29

10. Larson E, Aiello AE, Bastyr J, Lyle C, Stahl J, Cronquist A. et al. Assessment of two hand hygiene 30 regimens for intensive care unit personnel. Crit Care Med 2001; 29(5): 944-951. 31

11. Larson EL, Cimiotti J, Haas J, Parides M, Nesin M, Della-Latta P, Saiman L. Effect of antiseptic 32 handwashing vs alcohol sanitizer on health care- associated infections in neonatal intensive care 33 units. Arch Pediat Adol Med 2005; 159: 377-383. 34

12. Forrester BG, Roth VS. Hand dermatitis in intensive care units. J Occup Environ Med 1998; 40(10): 35 881-885. 36

13. Larson E, Silberger M, Jakob K, Whittier S, Lai L, Latta PD et al. Assessment of alternative hand 37 hygiene regimens to improve skin health among neonatal intensive care unit nurses. Heart Lung 38 2000; 29(2): 136-142. 39

14. Kampf G, Muscatiello M. Dermal tolerance of sterillium, a propanol-based hand rub. J Hosp Infect 40 2003; 55: 295-298. 41

15. Pittet D, Hugonnet S, Harbarth S, Mourouga P, Sauvan V, Touveneau S. Effectiveness of a hospital 42 wide programme to improve compliance with hand hygiene. Lancet 2000; 356: 1307-1312. 43

16. Pittet D, Allegranzi B, Sax H, Chraiti MN, Griffiths W, Richet H; World Health Organization Global 44 Patient Safety Challenge Alcohol-Based Handrub Task Force. Double-blind, randomized, crossover 45 trial of 3 hand rub formulations: fast-track evaluation of tolerability and acceptability. Infect Control 46 Hosp Epideiol 2007; 28(12): 1344-1351. 47 48 49

How can adherence to hand hygiene guidance be promoted? 50 National and international guidelines emphasise the importance of adherence with 51 hand hygiene guidance and provide an overview of the barriers and factors that 52 impact on hand hygiene compliance.1-4 53 54 The use of multimodal approaches to improving hand hygiene practice has been 55 advocated for over ten years. Evidence from observational studies of multimodal 56 interventions involving the introduction of near patient ABHR, audit and feedback, 57 reminders and education is consistently associated with greater compliance by 58 healthcare staff. 5-19 59 60 An early systematic review of 21 studies involving interventions to improve hand 61 hygiene compliance concluded that: 62

single interventions have a short-term influence on hand hygiene; 63

37

reminders have a modest but sustained effect; 1 feedback increases rates of hand hygiene but must be regular; 2 near patient alcohol-based preparations improve the frequency with which 3

healthcare workers clean their hands; 4 multi-faceted approaches have a more marked effect on hand hygiene and 5

rates of HCAI.5 6 7 National hand hygiene campaigns have been modelled on the multimodal approach 8 and implemented across the world.4 In England and Wales the National Patient 9

10 2004 and 2008 with the aim of creating sustainable change in hand hygiene 11 compliance. The campaign comprised the use of near patient ABHR, national poster 12 materials, audit and feedback and materials for patient engagement. 13 14 Recent Cochrane Reviews of randomised and controlled clinical trials, interrupted 15 time series and controlled before-after studies have suggested that the majority of 16 studies conducted in this field have methodological biases that exclude them from 17 this review.20,21 We identified four SRs of interventions to improve hand hygiene 18 compliance.21-24 The most recent review identified 84 studies published after 2006 for 19 potential inclusion, but only four studies, one RCT, two interrupted time series and 20 one controlled before-after study, were included following detailed quality 21 assessment.21 The heterogeneity of interventions and methods precluded the pooling 22 and meta-analysis of results and concluded that multifaceted campaigns that include 23 social marketing or staff engagement may be more effective than campaigns without 24 these components, and that education or product substitution alone are less 25 effective. An integrative SR of 35 studies reporting a wide range of interventions, 26 including multimodal interventions and hand hygiene product changes, only scored 27 nine of the included studies as having limited or no fatal flaws.22 The authors 28 concluded that design limitations made it difficult to generalise study results or isolate 29 the specific effects of hand hygiene (or other interventions) on reductions of HCAI. 30

31 rates of colonisation as the primary outcome, identified 33 potential studies for 32 inclusion and of these only four had quality scores of >80%. Again, due to the 33 heterogeneity of study interventions and outcomes, the results were narratively 34 synthesised.23 The authors concluded that the formation of multidisciplinary quality 35 improvement teams and educational interventions might be effective strategies to 36 improve hand hygiene and reduce rates of HCAI. The final SR focused specifically 37 on educational interventions to improve hand hygiene compliance in hospital settings 38 and included all study designs reporting at least one outcome measure of hand 39 hygiene competence and with a follow-up of at least six months.24 Thirty studies met 40 the inclusion criteria for the review, but it was not possible to separate competence 41 from compliance. Educational interventions taught or re-taught the correct methods 42 for hand hygiene and then assessed compliance. The authors concluded that 43 educational interventions had a greater impact if compliance to hand hygiene was 44 low. Multiple interventions were better than single interventions in sustaining 45 behaviour change, as were continuous, rather than one-off interventions. However, it 46 was not possible to determine the duration or sustainability of behaviour change in 47 these studies. 48 49 Our SR also identified one cluster RCT and process evaluation, one step-wedge 50 cluster RCT, two interrupted time series studies and one controlled before-after study 51 that evaluated multimodal interventions with varying components.25-29 In a cluster 52 RCT that also included a process evaluation, the authors tested a set of core 53

54 strategy (TDS), at baseline (T1), immediately following the intervention (T2) and six 55

38

months later (T3), to ascertain the additional benefits of leadership and staff 1 engagement components.25 In the intention to treat analysis (ITT), an odds ratio (OR) 2 of 1.64 (95% CI 1.33 to 2.02; p<0.001) in favour of the TDS between T2 and T3 3 suggests that engaging ward leadership and the involvement of teams in setting 4 norms and targets results in greater compliance with hand hygiene. However, there 5

6 (p=0.187), with the SAS also having a sustained effect. The process evaluation 7 examined the extent to which the content, dosage and coverage of the intervention 8 had been delivered.26 An as treated analysis demonstrated a greater effect size for 9 the TDS at T3 with a significant difference in hand hygiene compliance (p<0.01). The 10 process evaluation also suggested that experienced feedback about individual hand 11 hygiene performance at T2 and T3 (p<0.05 and p<0.01, respectively), challenging 12 colleagues on undesirable hand hygiene practice (p<0.01) and support from 13 colleagues in performing hand hygiene (p<0.01) were positively correlated with 14

26 15 16 The second cluster RCT used a step-wedge design to assess a behavioural 17 feedback intervention in intensive care units (ICU) and acute care of the elderly 18 (ACE) wards at sites partici 27 The 19 intervention was delivered over a four-week cycle, which involved observation of 20 individual healthcare workers with immediate feedback and team feedback with 21 action planning. There was a lack of fidelity to the intervention, with only 33% of the 22 implementing wards returning four data forms per month. The ITT analysis showed 23 an estimated OR for an increase in hand hygiene compliance of 1.103 (95% CI 1.026 24 to 1.188; p=0.008) for each returned data form, but no similar effect in ACE wards, 25 with an estimated OR of 0.998 (95% CI 0.948 to 1.050; p=0.9) for each returned 26 form. The per-protocol analysis showed an increased OR for ICU (OR 2.09; 95% CI 27 1.55 to 2.81; p<0.003) that also showed greater fidelity to the intervention and ACE 28 wards (OR 1.67; 95% CI 1.28 to 2.22; p<0.001). Authors concluded that individual 29 feedback and team action-planning resulted in moderate but sustained improvements 30 in hand hygiene adherence. The difficulties in implementing this intervention point to 31 the problems that might be faced in a non-trial context. 32 33

34 -wide programme in Taiwan both 35

demonstrated increased hand hygiene compliance (measured by procurement of 36 ABHR and liquid soap) and reductions in HCAI (MRSA and C. difficile and MRSA 37 and extensively drug-resistant Acinetobacter XDRAB).28,29 In the national study, 38 increased procurement of soap was independently associated with reductions in C. 39 difficile infection (adjusted incidence rate ratio for 1 mL increase per patient bed day 40 0.993; 95% CI 0.990 to 0.996; p<0.0001) and MRSA in the last four quarters of the 41 study (adjusted incidence rate ratio for 1 mL increase per patient bed day 0.990; 95% 42 CI 0.985 to 0.995; p<0.0001).28 43 independent of other national programmes to reduce MRSA bloodstream infections 44 and C. difficile infection. Analysis also identified that the publication of the Health Act 45 and the Department of Health improvement team visits were associated with 46 reductions in MRSA and C.difficile. In the hospital-wide study,29 authors 47 demonstrated a decrease in the cumulative incidence of HCAIs caused by MRSA 48 (change in level, p=0.03; change in trend, p=0.04); and XDRAB (change in level 49 p=0.78; change in trend p<0.001) during the intervention period. Hand Hygiene 50 compliance was significantly correlated with increased consumption of ABHR and 51 improved overall from 43.3% in 2004 to 95.6% in 2007 (p<.001) and for professional 52 categories of healthcare workers (p<.001), in both general wards and intensive care 53 units (p<.001). 54 55

39

The controlled before after study30 of a range of patient safety interventions in 1 England, including hand hygiene, as measured by ABHR and soap consumption in 2 non-specialist acute hospitals, reported no significant differences in the rate of 3 increase in consumption of ABHR (p=0.760 favouring controls and p=0.889 favouring 4 intervention) and non-significant decreases in C. difficile (p=0.652) and MRSA 5 (p=0.693). 6 7 SP15

Near patient alcohol-based hand rub should be made available in all healthcare facilities. [No change]

Class C

SP16 Hand hygiene resources and individual adherence to

hand hygiene guidelines should be audited at regular intervals and the results fed back to healthcare workers to improve and sustain high levels of compliance. [Revised recommendation]

Class C

SP17 Education and training in risk assessment, effective

hand hygiene and glove use should form part of all

[No change]

Class D/ GPP

SP18 Local programmes of education, social marketing, and audit and feedback should be refreshed regularly and promoted by senior managers and clinicians to maintain focus, engage staff and produce sustainable levels of compliance. [New recommendation]

Class C

References 8 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 9

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 10 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 11 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 12 Hospital-acquired Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 13

2. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 14 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 15 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 16

3. Boyce JM, Pittet D. Guideline for Hand Hygiene in Healthcare Settings. Recommendations of the 17 Healthcare Infection Control Practice Advisory Committee and the HICPAC/SHEA/APIC/IDSA 18 Hygiene Task Force 2002. p.58. 19

4. World Health Organization: WHO Patient Safety. WHO guidelines on hand hygiene in health care. 20 World Health Organization. Geneva: 2009. 21

5. Naikoba S, Hayward A. The effectiveness of interventions aimed at increasing handwashing in 22 healthcare workers a systematic review. J Hosp Infect 2001; 47(3): 173-180. 23

6. Pittet D, Hugonnet S, Harbarth S, Mourouga P, Sauvan V, Touveneau S. Effectiveness of a hospital 24 wide programme to improve compliance with hand hygiene. Lancet 2000; 356: 1307-1312. 25

7. Hilburn J, Hammond BS, Fendler EJ, Groziak PA. Use of alcohol hand sanitizer as an infection 26 control strategy in an acute care facility. Am J Infect Control 2003; 31(2): 109-116. 27

8. Rosenthal VD. Guzman S, Safdar N. Reduction in nosocomial infection with improved hand hygiene 28 in intensive care units of a tertiary care hospital in Argentina. Am J Infect Control 2005; 33(7): 392-29 397. 30

9. Rosenthal VD, McCormick RD, Guzman S, Villamayor C, Orellano PW. Effect of education and 31 performance feedback on handwashing: the benefit of administrative support in Argentinean 32 hospitals. Am J Infect Control 2003; 31(2): 85-92. 33

10. Won SP, Chou HC, Hsieh WS, Chen CY Huang SM, Tsou KI, Tsao PN. Handwashing programme 34 for the prevention of nosocomial infections in a neonatal intensive care unit. Infect Control Hosp 35 Epidemiol 2004; 25(9): 742-746. 36

40

11. Macdonald A, Dinah F, Mackenzie D, Wilson A. Performance feedback of hand hygiene, using 1 alcohol hand gel as the skin decontaminant, reduces the number of inpatients newly affected by 2 MRSA and antibiotic costs. J Hosp Infect 2004; 56: 56-63. 3

12. Wendt C, Knautz D, Baum H. Differences in hand hygiene behaviour related to the contamination 4 risk of healthcare activities in different groups of healthcare workers. Infect Control Hosp Epidemiol 5 2004; 25(3): 203-206. 6

13. Cohen B, Saiman L, Cimmiotti J, Larson E. Factors associated with hand hygiene practices in two 7 neonatal intensive care units. Pediatr Infect Dis J 2003; 22(6): 494-498. 8

14. Brown SM Lubimova AV, Khrustalyeva NM, Shulaeva SV, Tekhova I, Zueva LP, Goldmann D, 9 -based hand rub and quality improvement interventions to improve 10

hand hygiene in a Russian neonatal intensive care unit. Infect Control Hosp Epidemiol 2003; 24(3): 11 172-179. 12

15. Kuzu N, Ozer F, Aydemir S et al Compliance with hand hygiene and glove use in a university-13 affiliated hospital. Infect Control Hosp Epidemiol 2005; 26(3): 312-315. 14

16. Kim PW, Roghmann M, Perencevich EN et al Rates of hand disinfection associated with glove use, 15 patient isolation, and changes between exposure to various body sites. Am J Infect Control 2003; 16 31(2): 97-103. 17

17. Hilburn J, Hammond BS, Fendler EJ, Groziak PA. Use of alcohol hand sanitizer as an infection 18 control strategy in an acute care facility. Am J Infect Control 2003; 31(2): 109-116. 19

18. McGuckin M, Taylor A, Martin V, Porten L, Salcido R. Evaluation of a patient education model for 20 increasing hand hygiene compliance in an inpatient rehabilitation unit. Am J Infect Control 2004; 21 32(4): 235-238. 22

19. McGuckin M. Waterman R. Storr J. Bowler ICJ. Ashby M. Topley K. Porten L. Evaluation of a 23 patient-empowering hand hygiene programme in the UK. J Hosp Infect 2001; 48(3): 222-227. 24

20. Gould D, Chudleigh JH, Moralejo D, Drey N. Interventions to improve hand hygiene compliance in 25 patient care. Cochrane Database Syst Rev 2007; 2. 26

21. Gould DJ, Moralejo D, Drey N, Chudleigh JH. Interventions to improve hand hygiene compliance in 27 patient care. Cochrane Database Syst Rev 2011; 8. 28

22. Backman C, Zoutman DE, Marck PB. An integrative review of the current evidence on the 29 relationship between hand hygiene interventions and the incidence of health care-associated 30 infections. Am J Infect Control 2008; 36: 333-348 31

23. Aboelela SW, Stone PW, Larson EL. Effectiveness of bundled behavioural interventions to control 32 healthcare-associated infections: a systematic review of the literature. J Hosp Infect 2007; 66: 101-33 108. 34

24. Cherry MG, Brown JM, Bethell GS, Neal T, Shaw NJ.Features of educational interventions that lead 35 to compliance with hand hygiene in healthcare professionals within a hospital care setting. A BEME 36 systematic review: BEME Guide No. 22. Med Teach. 2012. 37

25. Huis A, Schoonhoven L, Grol R, Donders R, Hulscher M, van Achterberg T. Impact of a team and 38 leaders-directed strategy to improve nurses' adherence to hand hygiene guidelines: a cluster 39 randomised trial. Int J Nurs Stud 2013; 50(4): 464-74. 40

26. Huis A. Holleman G,van Achterberg T, Grol R, Schoonhoven L, Hulscher M. Explaining the effects 41 of two different strategies for promoting hand hygiene in hospital nurses: a process evaluation 42 alongside a cluster randomised controlled trial. Implement Sci 2013; 8(41). 43

27. Fuller C, Michie S, Savage J, McAteer J, Besser S, et al. (2012) The Feedback Intervention Trial 44 (FIT) - Improving Hand-Hygiene Compliance in UK Healthcare Workers: A Stepped Wedge Cluster 45 Randomised Controlled Trial. PLoS ONE 7(10): e41617. 46

28. Stone SP, Fuller C, Savage J, Cookson B, Hayward A, Coope B, Duckworth G, Michie S, Murray 47 M, Jeanes A, Roberts J, Teare L, Charlat A. Evaluation of the National Cleanyourhands Campaign 48 to reduce Staphylococcus aureus bacteraemia and Clostridium difficle infection in hospitals in 49 England and Wales by improved hand hygiene: four year prospective, ecological interrupted time 50 series study. BMJ 2012; 344: e3005. 51

29. Chen YC. Sheng WH. Wang JT. Chang SC. Lin HC. Tien KL. Hsu LY. Tsai KS. Effectiveness and 52 limitations of hand hygiene promotion on decreasing healthcare associated infections. PLoS ONE 53 2011; 6(1): e27163. 54

30. Benning A. Dixon-Woods M. Nwulu U. Ghaleb M. Dawson J. Barber N. Franklin BD. Girling A. 55 Hemming K. Carmalt M. Rudge G. Naicker T. Kotecha A. Derrington MC. Lilford R. Multiple 56 component patient safety intervention in English hospitals: controlled evaluation of second phase. 57 BMJ 2011; 342: d199. 58

59

41

Patient Involvement in Hand Hygiene 1 Patient involvement in multimodal strategies to improve hand hygiene among 2 healthcare workers is established, although research suggests that many patients 3 and carers do not feel empowered to challenge doctors in particular.1-5 Many NHS 4 trusts have promoted hand hygiene among visitors by placing ABHR at the entrances 5 to wards and patient rooms. However, despite being highlighted as an important gap 6 in research, the role of patient hands in the cross transmission of microorganisms 7 has not been investigated systematically, other than in ecologic studies that describe 8 hand or skin contamination6-8 or observations of non-use of hand hygiene products.9 9 Studies of effective interventions to enable patients to clean their hands remain 10 small-scale and descriptive in nature.10-13 11 12 We identified three studies that described interventions to improve patient hand 13 hygiene, one in an outbreak situation, one uncontrolled before-after study of parent 14 education in a single paediatric intensive care unit and the other as part of a 15 prospective observational study in a community hospital, but none met the quality 16 criteria for inclusion in this SR.14-16 However, all suggested that improving 17 patient/carer hand hygiene had some effect on cross-transmission of microorganisms 18 and hand hygiene technique. National guidelines indicate that it is important to 19 educate patients and carers about the importance of hand hygiene and inform them 20 about the availability of hand hygiene facilities and their role in maintaining standards 21 of healthcare worker hand hygiene.17 22 23 24 SP19 Patients and relatives should be informed about the

need to keep their own hands clean and encouraged to ask healthcare workers to decontaminate their hands before delivering care. [New recommendation]

Class D/ GPP

SP20 Patients should be offered the opportunity to clean their hands before meals, after using the toilet, commode or bedpan/urinal and at other times as appropriate. Products available should be tailored to patient needs and may include alcohol-based hand rub, hand wipes or access to hand wash basins. [New recommendation]

Class D/ GPP

25 References 26 1. World Health Organization: WHO Patient Safety. WHO guidelines on hand hygiene in health care. 27

World Health Organization. Geneva: 2009. 28 2. McGuckin M, Waterman R, Storr IJ, Bowler IC, Ashby M, Topley K, et al. Evaluation of a patient-29

empowering hand hygiene programme in the UK. J Hosp Infect 2001; 48: 222-7. 30 3. McGuckin M, Taylor A, Martin V, Porten L, Salcido R. Evaluation of a patient education model for 31

increasing hand hygiene compliance in an inpatient rehabilitation unit. Am J Infect Control 2004; 32: 32 235-8. 33

4. rceptions of their 34 participation to increase healthcare worker compliance with hand hygiene. Infect Control Hosp 35 Epidemiol 2009; 30: 830-9. 36

5. Lent V, Eckstein EC, Cameron AS, Budavich R, Eckstein BC, Donskey CJ. Evaluation of patient 37 participation in a patient empowerment initiative to improve hand hygiene practices in a Veterans 38 Affairs medical center. Am J Infect Control 2009; 37: 117-20. 39

6. Sanderson PJ, Weissler S. Recovery of coliforms from the hands of nurses and patients: activities 40 leading to contamination. J Hosp Infect 1992; 21: 85-93. 41

7. Larson EL, Cronquist AB, Whittier S, Lai L, Lyle CT, Della LP. Differences in skin flora between 42 inpatients and chronically ill outpatients. Heart Lung 2000; 29: 298-305. 43

42

8. ds constitute a missing link? J Hosp Infect 2005; 1 61: 183-8. 2

9. Savage J, Fuller C, Besser S, Stone S. Use of alcohol hand rub (AHR) at ward entrances and use 3 of soap and AHR by patients and visitors: a study in 27 wards in nine acute NHS trusts. J Infect 4 Prev 2011; 12: 54-58. 5

10. Lawrence M. Patient hand hygiene: a clinical inquiry. Nurs Times 1983; 79:24-5. 6 11. 7

their hands. J Ren Care 2007; 33: 30-4. 8 12. Burnett E, Lee K, Kydd P. Hand hygiene: What about our patients? Br J Infect Control 2008; 9: 19-9

24. 10 13. Burnett E. Perceptions attitudes and behaviour towards patient hand hygiene. Am J Infect Control 11

2009; 37: 638-42. 12 14. Cheng VC, Wu AK, Cheung CH, Lau SK, Woo PC, Chan KH, Li KS, Ip IK, Dunn EL, Lee RA, Yam 13

LY, Yuen KY. Outbreak of human metapneumovirus infection in psychiatric inpatients: implications 14 for directly observed use of alcohol hand rub in prevention of nosocomial outbreaks. J Hosp Infect 15 2007; 67: 336-343. 16

15. Chen YC, Chiang LC. Effectiveness of hand-washing teaching programs for families of children in 17 paediatric intensive care units. J Clin Nurs 2007; 16: 1173 1179. 18

16. Gagne D, Bedard G, Maziade PJ. Systematic patient hand disinfection: impact on meticillin-19 resistant Staphylococcus aureus infection rates in a community hospital. J Hosp Infect 2010; 75: 20 269-72. 21

17. National Institute for Health and Care Excellence. Partial update of NICE Clinical Guideline 2. 22 Infection: prevention and control of healthcare associated infections in primary and community care. 23 (CG139). London: National Institute for Health and Care Excellence.24

43

2.4 The use of Personal Protective Equipment 1 2 3 This section discusses the evidence and associated recommendations for the use of 4 personal protective equipment (PPE) by healthcare workers in acute care settings 5 and includes the use of aprons, gowns, gloves, eye protection and face 6 masks/respirators. Where appropriate, in addition to the classification of the 7 evidence underpinning the recommendations, there is an indication of a Health and 8 Safety (H&S) requirement. 9 10 Infection prevention and control dress code protect your patients and 11 yourself. 12 The primary uses of PPE is to protect staff and reduce opportunities for cross-13 transmission of microorganisms in hospitals.1-3 There is no evidence that uniforms or 14 work clothing are associated with HCAI. However, there is a public expectation that 15 healthcare workers will wear work and protective clothing to minimise any potential 16 risk to patients.4,5 The decision to use or wear PPE must be based upon an 17 assessment of the level of risk associated with a specific patient care activity or 18 intervention and take account of current H&S legislation.6-8 However, studies have 19 identified that both a lack of knowledge of guidelines and non-adherence to guideline 20 recommendations are common and that regular in-service education and training is 21 required. 9-13 22 23 24 SP21 Selection of protective equipment must be based on an

assessment of the risk of transmission of microorganisms to the patient or to the carer, and the

secretions or excretions. [No Change]

ClassD/ GPP/ H&S

25 SP22 Everyone involved in providing care should be

educated about standard precautions and trained in the assessment of risk and the appropriate use of gloves in clinical care and other personal protective equipment. [Revised recommendation]

ClassD/ GPP/ H&S

26 SP23 Adequate supplies of disposable plastic aprons, single

use gloves and face protection should be made available wherever care is delivered. Gowns should be made available when advised by the infection prevention and control team. [Revised wording]

ClassD/ GPP/ H&S

27 28 References 29 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 30

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 31 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 32 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 33 Hospital-acquired Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 34

2. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 35 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 36 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 37

44

3. Expert Advisory Group on AIDS and the Advisory Group on Hepatitis. Guidance for clinical health 1 care workers: Protection against infection with blood-borne viruses. London: Department of Health. 2 1998. p.46. 3

4. Department of Health Uniforms and workwear: Guidance on uniform and workwear policies for NHS 4 employers. London. Department of Health. 2010. p.16. 5

5. Wilson JA, Loveday HP, Hoffman PN, Pratt RJ. Uniform: an evidence review of the microbiological 6 significance of uniforms and uniform policy in the prevention and control of healthcare-associated 7 infections. Report to the Department of Health (England). J Hosp Infect 2007; 66: 301-307. 8

6. Health and Safety Executive. Management of Health and Safety at Work Regulations. London: HSE 9 Books. 1999. 10

7. Health and Safety Executive. Personal Protective Equipment at Work (Second edition) Personal 11 Protective Equipment at Work Regulations: Guidance on Regulations 1992 (as amended). London: 12 HSE Books 2005. Available at: http://www.hse.gov.uk/pubns/priced/l25.pdf. (Accessed 15 July 13 2013). 14

8. Health and Safety Commission. Control of Substances Hazardous to Health Regulations 2002. 15 Approved Codes of Practice. London: HSE Books. 2002. 16

9. Sax H, Perneger T, Hugonnet S, Herrault P, Chraiti M, Pittet D. Knowledge of standard and 17 isolation precautions in a large teaching hospital. Infect Control Hosp Epidemiol 2005; 26: 298-304. 18

10. Kuzu N, Ozer F, Aydemir S, Yalcin AN, Zencir M. Compliance with hand hygiene and glove use in a 19 university-affiliated hospital. Infect Control Hosp Epidemiol 2005; 26(3): 312-315. 20

11. Trim JC, Adams D, Elliot TSJ. edge of inoculation injuries and glove use. 21 Br Jour Nurs 2003; 12(4): 215-221. 22

12. Ferguson KJ, Waitzkin H, Beekmann SE, Doebbeling BN. Critical incidents of nonadherence with 23 standard precautions guidelines among community hospital-based health care workers. J Gen 24 Intern Med 2004; 19: 726-730. 25

13. Prieto J, McCleod Clark J. Contact Precautions for Clostridium difficile and Methicillin-resistant 26 Staphylococcus aureus (MRSA): Assessing the impact of a supportive intervention to improve 27 practice. J Res Nurs 2005; 10(5): 511-526. 28

29 30 Gloves: use them appropriately 31 Since the mid-1980s the use of gloves as an element of PPE has become an every-32 day part of clinical practice for healthcare workers.1-3 There are two main indications 33 for the use of gloves in preventing HCAI:1 34 35

to protect hands from contamination with organic matter and microorganisms; 36 to reduce the risks of transmission of microorganisms to both patients and 37

staff. 38 39 In addition, there may be other indications not related to preventing the cross-40 transmission of infection, which require clinical gloves to be worn, e.g. the use of 41 some chemicals or medications. 42 43 Gloves should not be worn unnecessarily, as their prolonged and indiscriminate use 44 may cause adverse reactions and skin sensitivity and may lead to cross-45 contamination of the patient environment.1,2 We identified four observational studies 46 that suggested that clinical gloves are not used in line with current guidance and that 47 glove use impacts negatively on hand hygiene.4-7 48 49 The need to wear clinical gloves and the selection of appropriate glove materials 50 requires careful assessment of the task to be carried out and its related risks to 51 patients and healthcare workers.1-3,8,9 Risk assessment should include consideration 52 of: 53 54

who is at risk (patient or healthcare worker) and whether sterile or non-sterile 55 gloves are required; 56

the potential for exposure to blood, body fluids, secretions and excretions; 57 contact with non-intact skin or mucous membranes during care and invasive 58

procedures; 59

45

healthcare worker and patient sensitivity to glove materials. 1 2 Gloves must be removed immediately after each care activity for which they were 3 worn in order to prevent the cross-transmission of microorganisms to other 4 susceptible sites in that individual or to other patients.1 Gloves should not be washed 5 or decontaminated with ABHR as a substitute for changing gloves between care 6 activities.10 7 8 Gloves are not infallible 9 There is evidence that hands become contaminated when clinical gloves are worn, 10 even when the integrity of the gloves appear undamaged.1-3 In terms of leakage, 11 gloves made from natural rubber latex (NRL) perform better than vinyl gloves in 12 laboratory test conditions.1,2 Revised standards for the manufacture of medical 13 gloves for single use require all clinical gloves to perform to the same standard, 14 regardless of material.11-13 However, the integrity of gloves cannot be guaranteed, 15 and additionally, hands may become contaminated during the removal of gloves.1,2,14 16 The appropriate use of clinical gloves provides barrier protection and reduces the risk 17 of hand contamination from blood, body fluids, secretions and excretions, but do not 18 eliminate the risk. Hands cannot be considered to be clean because gloves have 19 been worn. Hands should be decontaminated with soap and water and dried with 20 good quality paper towels following the removal of gloves. 21 22 23 SP24 Gloves must be worn for invasive procedures, contact

with sterile sites, and non-intact skin or mucous membranes, and all activities that have been assessed as carrying a risk of exposure to blood, body fluids, secretions and excretions; and when handling sharp or contaminated devices. [No change]

ClassD/ GPP/ H&S

SP25 Gloves must be worn as single use items. They are put on immediately before an episode of patient contact or treatment and removed as soon as the activity is completed. Gloves are changed between caring for different patients, or between different care/treatment activities for the same patient. [Revised wording]

ClassD/ GPP/ H&S

24 SP26 Gloves must be disposed of as clinical waste and hands

decontaminated with liquid soap and water immediately after the gloves have been removed. [Revised wording]

ClassD/ GPP/ H&S

25 26 References 27 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 28

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 29 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 30 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 31 Hospital-acquired Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 32

2. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 33 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 34 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 35

3. Expert Advisory Group on AIDS and the Advisory Group on Hepatitis. Guidance for clinical 36 healthcare workers: protection against infection with blood borne viruses. London: UK Health 37 Departments; 1998. 38

46

4. 1 ICHE 2011; 32: 1194-2

1199. 3 5. Eveillard M, Guilloteau V, Kempf M, Lefrancq B, Pradelle MT, Raymond F, Joly-Guillou ML, Brunel 4

PP.. Impact of improving glove usage on the hand hygiene compliance. Am J Infect Control 2011; 5 39: 608-610. 6

6. Eveillard M, Pradelle MT, Lefrancq B, Guilloteau V, Rabjeau A, Kempf M, Vidalenc O, Grosbois M, 7 Zilli-Dewaele M, Raymond F, Joly-Guillou ML, Brunel P. Measurement of hand hygiene compliance 8 and gloving practices in different settings for the elderly considering the location of hand hygiene 9 opportunities during patient care. Am J Infect Control 2011; 39: 339-341. 10

7. Katherason SG, Lin Naing L, Jaalam K, Mohamad NA, Bhojwani K, Harussani N, Ismail A. Hand 11 decontamination practices and the appropriate use of gloves in two adult intensive care units in 12 Malaysia. J Infect Dev Ctries 2010; 4(2): 118-123. 13

8. Health and Safety Executive. Selecting Latex Gloves. Available at 14 http://www.hse.gov.uk/skin/employ/latex-gloves.htm (Accessed 5 June 2013). 15

9. Health and Safety Executive. Choosing the right gloves to protect skin: a guide for employers. 16 Available at http://www.hse.gov.uk/skin/employ/gloves.htm (Accessed 5 June 2013). 17

10. World Health Organization: WHO Patient Safety. WHO guidelines on hand hygiene in health care. 18 World Health Organization. Geneva: 2009. 19

11. British Standards Institution. Medical Gloves for Single Use Part 1: Specification for freedom from 20 holes. BS-EN 455-1 London: BSI 2000. 21

12. British Standards Institution. Medical Gloves for Single Use Part 2: Specification for physical 22 properties. BS-EN 455-2 London: BSI 2000. 23

13. British Standards Institution. Medical Gloves for Single Use Part 3: Requirements and testing for 24 biological evaluation. BS-EN 455-3 London: BSI 2000. 25

14. Tenorio AR, Badri SM, Sahgal NB, Hota B, Matushek M, Hayden MK, Trenholme GM, Weinstein 26 RA. Effectiveness of gloves in the prevention of hand carriage of vancomycin-resistant 27 enterococcus species by health care workers after patient care. Clin Infect Dis 2001; 32: 826-829. 28

29 30 Making choices 31 Clinical gloves should be used by healthcare workers to prevent the risk of hand 32 contamination with blood, body fluids, secretions and excretions and to protect 33 patients from potential cross-contamination of susceptible body sites or invasive 34 devices.1,2 Having decided that gloves should be used for a healthcare activity, the 35 healthcare worker must make a choice between the use of: 36 37

sterile or non-sterile gloves, based on contact with susceptible sites or clinical 38 devices; 39

surgical or examination gloves, based on the aspect of care or treatment to 40 be undertaken. 41

42 Healthcare organisations must provide gloves that conform to European Standards 43 (EN455-1, 455-2, 455-3), and which are acceptable to healthcare practitioners.1-4 44 Gloves are available in a variety of materials, the most common being NRL, which 45 remains the material of choice, due to its efficacy in protecting against blood borne 46 viruses and properties that enable the wearer to maintain dexterity.1,5 Patient or 47 healthcare practitioner sensitivity to NRL proteins must also be taken into account 48 when deciding on glove materials.6 49 50 Synthetic glove materials are generally more expensive than NRL and may not be 51 suitable for all purposes.1 Nitrile gloves have the same chemical range as NRL and 52 may also lead to sensitivity problems in healthcare workers and patients. Polythene 53 gloves are not suitable for clinical use, due to their permeability and tendency to 54 damage easily.1 A study comparing the performance of nitrile, latex, copolymer and 55 vinyl gloves under stressed and unstressed conditions found that nitrile gloves had 56 the lowest failure rate, suggesting that nitrile gloves are a suitable alternative to NRL, 57 providing there are no sensitivity issues. Importantly, the study noted variation in 58 performance of the same type of glove produced by different manufacturers.5 The 59

47

Health and Safety Executive (H&SE) also provide a guide to glove selection for 1 employers.7 2 3 4 SP27 Gloves that are acceptable to healthcare personnel and

CE marked must be available in all clinical areas. [No change]

ClassD/ GPP/ H&S

SP28 Sensitivity to natural rubber latex in patients, carers and

healthcare workers must be documented and alternatives to natural rubber latex must be available. [Revised wording]

ClassD/ GPP/ H&S

5 SP29 Do not use polythene gloves for healthcare activities.

[Revised wording] ClassD/ GPP/ H&S

6 7 References 8 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 9

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 10 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 11 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 12 Hospital-acquired Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 13

2. British Standards Institution. Medical Gloves for Single Use Part 1: Specification for freedom from 14 holes. BS-EN 455-1 London: BSI 2000. 15

3. British Standards Institution. Medical Gloves for Single Use Part 2: Specification for physical 16 properties. BS-EN 455-2 London: BSI 2000. 17

4. British Standards Institution. Medical Gloves for Single Use Part 3: Requirements and testing for 18 biological evaluation. BS-EN 455-3 London: BSI 2000. 19

5. Korniewicz DM, El-Masri M, Broyles JM. To determine the effects of gloves stress, type of material 20 (vinyl, nitrile, copolymer, latex) and manufacturer on the barrier effectiveness of medical 21 examination gloves. Am J Infect Control 2002; 30(2): 133-138. 22

6. Health and Safety Executive. Selecting Latex Gloves. Available at 23 http://www.hse.gov.uk/skin/employ/latex-gloves.htm (Accessed 5 June 2013). 24

7. Health and Safety Executive. Choosing the right gloves to protect skin: a guide for employers. 25 Available at http://www.hse.gov.uk/skin/employ/gloves.htm (Accessed 5 June 2013). 26

27 28 Aprons or gowns? 29 We identified a systematic review (SR) of the evidence that microbial contaminants 30 found on the work clothing of healthcare practitioners are a significant factor in cases 31 of HCAI. Reviewers identified seven small scale studies describing the progressive 32 contamination of work clothing during clinical care and a further two studies that 33 suggested a link with microbial contamination and infection.1-11 One of the two 34 studies was conducted in a simulated scenario and demonstrated that it was possible 35 to transfer Staphylococcus aureus 36 was not associated with clinical infection.10 A further study, associated with an 37 outbreak of Bacillus cereus, showed an epidemiological link between contaminated 38 clothing and HCAI, but this occurred when surgical scrub suits became highly 39 contaminated in an industrial laundry, rather than as a result of clinical care.11 A 40 further study demonstrated high levels of contamination of gowns, gloves and 41 stethoscopes with vancomycin-resistant enterococci (VRE) following examination of 42 patients known to be infected.12 43 44 A SR of eight studies assessing the effects of gowning by attendants and visitors 45 found no evidence to suggest that over gowns are effective in reducing mortality, 46 clinical infection or bacterial colonisation in infants admitted to newborn nurseries.13 47 One quasi-experimental study investigated the use of gowns and gloves as opposed 48

48

to gloves only in preventing the acquisition of VRE in a medical intensive care unit 1 (ICU) setting.14 A further prospective observational study investigated the use of a 2 similar intervention in a medical ICU.15 These studies suggested that the use of 3 gloves and gowns may minimise the transmission of VRE when colonisation 4 pressure is high. 5 6 National and international guidelines recommend that protective clothing should be 7 worn by all healthcare workers when close contact with the patient, materials or 8 equipment may lead to contamination of uniforms or other clothing with 9 microorganisms, or when there is a risk of contamination with blood, body fluids, 10 secretions, or excretions (with the exception of perspiration).17-19 Disposable plastic 11 aprons are recommended for general clinical use.17,18 Full body gowns need only be 12 used where there is the possibility of extensive splashing of blood, body fluids, 13 secretions or excretions and should be fluid repellent.17,18 14 15 16 SP30 Disposable plastic aprons must be worn when close

contact with the patient, materials or equipment are anticipated and when there is a risk that clothing may become contaminated with pathogenic microorganisms or blood, body fluids, secretions or excretions, with the exception of perspiration. [No change]

ClassD/ GPP/ H&S

SP31 Plastic aprons/gowns should be worn as single-use

items, for one procedure or episode of patient care, and then discarded and disposed of as clinical waste. Non-disposable protective clothing should be sent for laundering. [No change]

ClassD/ GPP/ H&S

17 SP32 Full-body fluid-repellent gowns must be worn where

there is a risk of extensive splashing of blood, body fluids, secretions or excretions, with the exception of perspiration, onto the skin or clothing of healthcare workers. [No change]

ClassD/ GPP/ H&S

18 19 References 20 1. Wilson JA, Loveday HP, Hoffman PN, Pratt RJ. Uniform: an evidence review of the microbiological 21

significance of uniforms and uniform policy in the prevention and control of healthcare-associated 22 infections. Report to the Department of Health (England). J Hosp Infect 2007; 66, 301-307. 23

2. Nye KJ, Leggett VA, Watterson L. Provision and decontamination of uniforms in the NHS. Nurs 24 Stand 2005; 19: 41-45. 25

3. Staphylococcus 26 aureus. Lancet 1969; 2(7614): 233-235. 27

4. 28 isolation ward. J Hosp Infect 1983; 4: 149-157. 29

5. Nurs Stand 1998; 13: 37-42. 30 6. Perry C, Marshall R, Jones E. Bacterial contamination of uniforms. Short Report. J Hosp Infect 31

2001; 48: 238-241. 32 7. Boyce JM, Potter-Bynoe G, Chenevert C, King T. Environmental contamination due to methicillin-33

resistant Staphylococcus aureus: possible infection control implications. Infect Control Hosp 34 Epidemiol 1997; 18: 622-627. 35

8. Br Med J 1991; 303: 21-28. 36 9. Loh W, Ng VV, Holton J. Bacterial flora on the white coats of medical students. J Hosp Infect 2000; 37

45: 65-68. 38

49

10. J Hyg 1973; 71: 799-814. 1 11. Barrie D, Wilson JA, Hoffman PN, Kramer JM. Bacillus cereus meningitis in two neurosurgical 2

patients: an investigation into the source of the organism. J Infect 1992; 25: 291-297. 3 12. Barrie D, Wilson J, Kramer J, Hoffman P. Contamination of hospital linen by Bacillus cereus. 4

Epidemiol Infect 1994; 113: 297-306. 5 13. Zachary KC, Bayne PS, Morrison VJ, Ford DS, Silver LC, Hooper DC. Contamination of gowns, 6

gloves, and stethoscopes with vancomycin-resistant enterococci. Infect Control Hosp Epidemiol 7 2001; 22(9): 560-564. 8

14. Webster J, Pritchard MA. Gowning by attendants and visitors in newborn nurseries for prevention of 9 neonatal morbidity and mortality (Review). Cochrane Database Sys Rev 2003; 2: 1-23. 10

15. Puzniak LA, Leet T, Mayfield J, Kollef M, Mundy LM. To gown or not to gown: The effect on 11 acquisition of vancomycin-resistant enterococci. Clin Infect Dis 2002; 35: 18-25. 12

16. Srinivasan A, Song X, Ross T, Merz W, Brower R, Perl TM. A prospective study to determine 13 whether cover gowns in addition to gloves decrease nosocomial transmission of vancomycin-14 resistant enterococci in an intensive care unit. Infect Control Hosp Epidemiol 2002; 23(8): 424-428. 15

17. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 16 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 17 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 18

18. Garner JS, Hospital Infection Control Practices Advisory Committee. Guideline for isolation 19 precautions in hospitals. Infect Control Hosp Epidemiol 1996; 17(1): 53-80, and Am J Infect Control 20 1996; 24: 24-52. 21

19. Health and Safety Executive. Personal Protective Equipment at Work (Second edition) Personal 22 Protective Equipment at Work Regulations 1992 (as amended): Guidance on Regulations. London: 23 HSE Books 2005. 24

25 26 When is a facemask, respiratory protection and eye protection necessary? 27 Healthcare workers (and sometimes patients) may use standard, fluid-repellent 28 surgical facemasks to prevent respiratory droplets from the mouth and nose being 29 expelled into the environment. Facemasks are also used, often in conjunction with 30 eye protection, to protect the mucous membranes of the wearer from exposure to 31 blood and/or body fluids when splashing may occur. Our previous SRs failed to 32 reveal any robust experimental studies that demonstrated that healthcare workers 33 wearing surgical facemasks protected patients from HCAI during routine ward 34 procedures, such as wound dressing or invasive medical procedures.1,2 35 36 Facemasks are also used to protect the wearer from inhaling minute airborne 37 respiratory particles. As surgical facemasks are not effective at filtering out such 38 particles, specialised respiratory protective equipment is recommended for the care 39 of patients with certain respiratory diseases, e.g. active multiple drug-resistant 40 pulmonary tuberculosis, 3 Severe Acute Respiratory Syndrome (SARS) and 41 pandemic influenza4. The filtration efficiency of these masks (sometimes called 42

particles, but to be 43 effective, they must fit closely to the face to minimise leakage around the mask.1,2,5 44 45 We identified four SRs of the use of facial protection, all of which had been 46 undertaken in the aftermath of the SARS outbreak and in response to the H1N1 47 influenza pandemic. A range of study designs were considered in each of the 48 reviews, including cluster randomised controlled trials, randomised controlled trials 49 (RCTs), cohort studies and descriptive before-after studies. Overall, many studies 50 were poorly controlled and confounders, such as poor compliance in the weaker 51 studies, was not accounted for. Reviewers concluded that there was no strong 52 evidence that masks/respirators alone are effective in prevention of respiratory viral 53 infections. Masks/respirators should be used together with other protective 54 measures to reduce transmission.6-9 55 56 Our previous SR indicated that different protective eyewear offered protection against 57 physical splashing of infected substances into the eyes (although not on all 58 occasions), but that compliance was poor.1 Expert opinion recommends that face 59

50

and eye protection reduce the risk of occupational exposure of healthcare workers to 1 splashes of blood, body fluids, secretion or excretions.1,2,10,11 2 3 4 SP33 Fluid repellent surgical face-masks and eye protection

must be worn where there is a risk of blood, body fluids, secretions or excretions splashing into the face and eyes. [Revised recommendation]

ClassD/ GPP/ H&S

SP34 An FFP3 facemask must be used when recommended

for the care of patients with respiratory infections transmitted by airborne particles. Each FFP3 device must be fit tested and fit checked for each use. [Revised recommendation]

ClassD/ GPP/ H&S

SP35 Personal protective equipment should be removed in

the following sequence to minimise the risk of cross-contamination:

Gloves Gown or apron Eye protection (when worn) Respirator or fluid-repellent surgical mask

[New recommendation]

ClassD/ GPP/ H&S

5 6 References 7 1. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 8

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 9 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 10 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 11 Hospital-acquired Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 12

2. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 13 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 14 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 15

3. National Collaborating Centre for Chronic Conditions for the National Institute for Health and 16 Clinical Excellence. Tuberculosis: Clinical diagnosis and management of tuberculosis, and 17 measures for its prevention and control. London: Royal College of Physicians 2006. p. 59-60. 18

4. Department of Health. Pandemic (H1N1) 2009 Influenza. A summary of guidance for infection 19 control in healthcare settings. 2009. p. 32 20

5. The Interdepartmental Working Group on Tuberculosis. The Prevention and Control of Tuberculosis 21 in the United Kingdom: UK Guidance on the prevention and control of transmission of 1. HIV-related 22 tuberculosis 2. Drug resistant, including multiple drug-resistant, tuberculosis. London: Department 23 of Health 1998. p.94. 24

6. Jefferson T, Del Mar C, Dooley L, et al. Physical interventions to interrupt or reduce the spread of 25 respiratory viruses (Review). Cochrane Database Syst Rev. 2010. 26

7. Cowling BJ, Zhou Y Ip DKM, Leung GM, Aaiello AE. Face masks to prevent transmission of 27 influenza virus: a systematic review Epidemiol Infect 2010; 138: 449-456. 28

8. Gralton J, McLaws ML. Protecting healthcare workers form pandemic influenza: N95 or surgical 29 masks. Crit Care Med 2010; 38: 657-67. 30

9. Bin-Reza F, Chavarrias VC, Nicoll A, Chamberland ME. The use of masks and respirators to 31 prevent transmission of influenza: a systematic review of the scientific evidence. Influenza Other 32 Respi Viruses; 6(4): 257-267. 33

10. Health and Safety Commission. Control of Substances Hazardous to Health Regulations 1999. 34 Approved Codes of Practice. HSE Books 1999: p.75. 35

11. Garner JS. Hospital Infection Control Practices Advisory Committee. Guideline for isolation 36 precautions in hospitals. Infect Control Hosp Epidemiol 1996; 17(1): 53-80, and Am J Infect Control 37 1996; 24: 24-52.38

51

2.5 The Safe Use and Disposal of Sharps 1 2 3 This section discusses the evidence and associated recommendations for the safe 4 use and disposal of sharps in general care settings. This includes minimising the 5 risks associated with sharps use and disposal and the use of needle protection 6 devices. Where appropriate, in addition to the classification of evidence 7 underpinning the recommendations, there is an indication of a Health and Safety 8 (H&S) legislation requirement. 9 10

Sharps injuries 11 The Health and Safety Executive (HSE) define a sharp as a needle, blade or other 12 medical instrument capable of cutting or piercing the skin. Similarly, a sharps injury 13 is an incident, which causes a needle, blade or other medical instrument to penetrate 14 the skin (percutaneous injury). The safe handling and disposal of needles and other 15 sharp instruments forms part of an overall strategy of clinical waste disposal to 16 protect staff, patients and visitors from exposure to bloodborne pathogens.1 17 18 In 2003, the National Audit Office found that needlestick and sharps injuries ranked 19 alongside moving and handling, falls, trips and exposure to hazardous substances as 20 the main types of accidents experienced by National Health Service (NHS) staff.2 In 21 2008, a Royal College of Nursing survey of 4,407 nurses found that almost half 22 (48%) had, at some point in their career, sustained a sharps injury from a device that 23 had previously been used on a patient. A similar number (52%) reported fearing 24 sharps injuries and nearly half (45%) reported that they had not received training 25 from their employer on safe needle use.3 from 26 the Health Protection Agency confirms that healthcare workers continue to be 27 exposed to bloodborne virus infections, even though such exposures are largely 28 preventable. The number of reported occupational exposures has almost doubled 29 from, 276 in 2002 to 541 in 2011, with almost half of all exposures occurring in 30 nurses.4 However, in 2011, medical and dental professions reported a similar 31 number of occupational exposures as nursing professions, with exposures in these 32 groups increasing by 131% between 2002 and 2011. The report draws attention to 33 the need for NHS Trusts to comply with the European Council Directive 2010/32/EU 34 and adopt safety devices in order to prevent sharps injuries.13 35 36 The average risk of transmission of bloodborne viruses following a single 37 percutaneous exposure from an infected person, in the absence of appropriate post 38 exposure prophylaxis, has been estimated to be:4 - 8 39 40

hepatitis B virus (HBV) (1 in 3) 41 hepatitis C virus (HCV) (1 in 30) 42 human immunodeficiency virus (HIV) (1 in 300) 43

44 National and international guidelines are consistent in their recommendations for the 45 safe use and disposal of sharp instruments and needles.6,9-11 As with many infection 46 prevention and control policies, the assessment and management of the risks 47 associated with the use of sharps is paramount and safe systems of work and 48 engineering controls must be in place to minimise any identified risks.12 A European 49 Council Directive 2010/32/EU Implementing the Framework Agreement on 50 Prevention from Sharps Injuries in the requires the 51 UK and all EU member states to introduce further protection for all healthcare 52 workers exposed to the risk of sharps injuries.13 Specifically, from May 2013, the 53

52

1 conduct risk assessments and put in place appropriate control measures. Employers 2 must also provide employees with adequate information and training.13 Any 3 healthcare worker sustaining an occupational exposure to blood or body fluids needs 4 to be assessed for the potential risk of infection by a specialist practitioner, e.g. a 5 physician or occupational health nurse, and offered testing, immunisation and post-6 exposure prophylaxis, where appropriate.14 7

8 The European Sharps Directive includes a new duty for employees who receive a 9 sharps injury whilst undertaking their work to inform their employer as soon as is 10 practicable.13 All healthcare workers must be aware of their responsibility in avoiding 11 sharps injuries. 12 13 We identified a systematic review (SR) that included the consideration of studies 14 focusing on education and training interventions to minimise the incidence of 15 occupational injuries involving sharps devices.15 The authors identified five primary 16 before-after studies that demonstrated a consistent reduction in the incidence of 17 percutaneous injuries when other safety initiatives, e.g. training, were implemented 18 before and during the introduction of safer sharps devices.16-20 These studies used a 19 range of interventions in one setting and are not generalisable. However, education 20 is essential in ensuring that staff understand safe ways of working and how to use 21 safety sharps devices. This should form a part of induction programmes for new staff 22 and on-going in-service education. The introduction of new devices should include 23 an appropriate training programme as part of staff introduction. 24 25 26 SP36 Sharps must not be passed directly from hand to hand

and handling should be kept to a minimum. [No change]

ClassD/ GPP/ H&S

SP37 Needles must not be recapped, bent broken or

disassembled after use. [No change]

ClassD/ GPP/ H&S

27 SP38 Used sharps must be discarded immediately, at the

point of use by the person generating the waste, into a sharps container conforming to current national and international standards. These must not be filled above the mark that indicates the bin is full. [Revised wording]

ClassD/ GPP/ H&S

SP39 All sharps containers must:

be positioned safely, away from public areas and out of the reach of children, and at a height that enables safe disposal by all members of staff;

be secured to avoid spillage; be temporarily closed when not in use; be disposed of when the fill line is reached or

every three months whichever is the sooner; not be filled above the fill line.

[Revised wording]

ClassD/ GPP/ H&S

SP40 All clinical and non-clinical staff must be educated ClassD/ GPP/

53

about the safe use and disposal of sharps. [No change]

H&S

1 2 References 3 1. Department of Health (2013) Health Technical Memorandum 07-01: safe management of 4

healthcare waste Available at: 5 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/167976/HTM_07-6 01_Final.pdf (Accessed 4 June 2013). 7

2. National Audit Office. A Safer Place to Work: improving the Management of Health and Safety 8 Risks to Staff in NHS Trusts. London: The Stationery Office; 2003. 9

3. Royal College of Nursing. Needlestick injury in 2008. Results from a survey of RCN members. 10 London: RCN. 11

4. Health Protection Agency. Eye of the Needle: United Kingdom Surveillance of Significant 12 Occupational Exposure to Bloodborne Viruses in Healthcare Workers. Centre for Infections; 13 London: Health Protection Agency; December 2012. Available at: 14 http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317137310957 (Accessed 04 June 2013). 15

5. Centers for Disease Control and Prevention. Workbook for Designing, Implementing and Evaluating 16 a Sharps Injury Prevention Program. 2006. Online: http://www.cdc.gov/sharpssafety/workbook.html 17 (Accessed 1 November 2006). 18

6. Expert Advisory Group on AIDS and the Advisory Group on Hepatitis. Guidance for clinical 19 healthcare workers: protection against infection with bloodborne viruses. London: UK Health 20 Departments; 1998. 21

7. Yazdanpanah Y, De Carli G, Migueres B, et al. Risk factors for hepatitis C transmission to health 22 care workers after occupational exposure: a European case-control study. Clin Infect Dis 2005; 41: 23 1423-30. 24

8. Department of Health. HIV Post-exposure prophylaxis: Guidance from the UK Chief Medical 25 Office S. London: Department of Health; September 2008. 26

9. Centers for Disease Control. Update. Universal Precautions for prevention of transmission of 27 human immunodeficiency virus, hepatitis B virus and other bloodborne pathogens in health care 28 settings. MMWR 1988; 37: 24. 29

10. Occupational Safety and Health Administration. Enforcement procedures for the occupational 30 exposure to bloodborne pathogens. Directive number CPL2-2.44D. 1999. p.69. 31

11. Department of Health. Health Technical Memorandum 07-01: Safe management of Healthcare 32 waste. London. Stationary Office. 2013. p187. Available at: 33 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/167976/HTM_07-34 01_Final.pdf (Accessed 5 June 2013). 35

12. Health and Safety Commission. Control of substances hazardous to health (Fifth edition) Control of 36 Substances Hazardous to Health Regulations 2002 (as amended). Approved Code of Practice and 37 guidance. London: HSE Books 2005. 38

13. Council Directive 2010/32/EU (2010) Implementing the framework agreement on prevention from 39 sharps injuries in the hospital and health care sector, concluded by HOSPEEM and EPSU, Official 40 Journal of European Union. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ. 41 do?uri=OJ:L:2010:134:0066:0072:EN:pdf (Accessed 5 June 2013) 42

14. Expert Advisory Group on AIDS. HIV Post-exposure Prophylaxis. London: Department of Health; 43 2000. p. 34. Available free of charge at: http://www.infectioncontrol.nhs.uk Available 4 June 2013) 44

15. HSE. An evaluation of the efficacy of safer sharps devices. Systematic Review 2012. Available at: 45 http://www.hse.gov.uk/research/rrpdf/rr914.pdf (Accessed 4 June 2013). 46

16. Brusaferro S, Calligaris L, Farneti F, Gubian F, Londero C, Baldo V. Educational programmes and 47 sharps injuries in health care workers. Occup Med (Oxf) 2009; 59 (7): 512-514. 48

17. Valls V, Lozano MS, Yanez R, Martinez MJ, Pascual F, Lloret J, Ruiz JA. Use of safety devices and 49 the prevention of percutaneous injuries among healthcare workers. Infect Control Hosp Epidemiol 50 2007; 28 (12): 1352-1360. 51

18. Adams D, Elliott TS. Impact of safety needle devices on occupationally acquired needlestick 52 injuries: a four-year prospective study. J Hosp Infect 2006; 64 (1): 50-55. 53

19. Zakrzewska JM, Greenwood I, Jackson J. Introducing safety syringes into a UK dental school--a 54 controlled study. Br Dent J 2001; 190 (2): 8892. 55

20. Yang YH, Liou SH, Chen CJ, Yang CY, Wang CL, Chen CY, Wu TN. The effectiveness of a training 56 program on reducing needlestick injuries/sharp object injuries among soon graduate vocational 57 nursing school students in southern Taiwan. J Occup Health 2007; 49 (5): 424-429. 58

59 60

54

Do needle protection devices reduce avoidable injuries? 1 To improve patient and staff safety the Department of Health and legislation requires 2 healthcare providers and their employees to pursue safer methods of working 3 through consideration of the benefits of new safety devices.1,2 The incidence of 4 sharps injuries has led to the development of safety devices in many different product 5 groups.3 They are designed to minimise the risk of operator injury during sharps use, 6

7 housekeeping or portering staff responsible for the collection of sharps disposal units. 8 9 The lack of well-designed, controlled intervention studies means that evidence to 10 show whether or not safety devices are effective in reducing rates of infection is 11 limited. However, a small number of studies have shown significant reductions in 12 injuries associated with the use of safety devices4 in cannulation,5,6 phlebotomy7-9 13 and injections.10 14 15 It would seem logical that where needle-free or other safety devices are used, there 16 should be a resulting reduction in sharps injuries. A review of needlestick injuries in 17

18 prevented if a safety device had been used.11 However, some studies identify a 19 range of barriers to the expected reduction in injuries, including staff resistance to 20 using new devices, complexity of device operation or improper use, and poor 21 training.4 A comprehensive report and product review conducted in the USA provides 22 background information and guidance on the need for and use of needlestick-23 prevention devices, but also gives advice on establishing and evaluating a sharps 24 injury prevention programme.3 The report identifies that all devices have limitations in 25 relation to cost, applicability and/or effectiveness. Some of the devices available are 26 more expensive than standard devices, may not be compatible with existing 27 equipment, and may be associated with an increase in bloodstream infection rates if 28 used incorrectly.12 29 30 The National Institute for Health and Care Excellence (NICE) identified three 31 randomised controlled trials (RCT) comparing safety cannulae with standard 32 cannulae. The studies were all in hospital settings and of low/very low quality. The 33 quality of evidence for safety needle devices was low, with no RCTs identified and 34 the five before-after implementation studies being of very low quality. The quality of 35 evidence for training was similarly low, with the type of training varying across the 36 five observational studies identified.13 37 38 We identified a SR undertaken by the HSE, which reviewed 41 studies that provided 39 evidence for reductions in the incidence of occupational sharps injuries associated 40 with use of sharps safety devices in reducing occupational injury, education and 41 training and the acceptability of sharps safety devices.14 Thirteen studies, 42 predominantly with observational designs, demonstrated that sharps safety devices 43 were associated with a significant reduction in the incidence of healthcare worker 44 needlestick injury.7-9,15-24 However, safety devices were not the total solution to 45 reducing occupational injury. The beneficial outcome of consulting with end users of 46 safer sharps devices before they are introduced was adequately demonstrated in five 47 studies identified in this review. 7,10, 25-28 48 49 In the USA, the Occupational Safety Health Administration (OSHA) and the National 50 Institute for Occupational Safety and Health (NIOSH) suggest that a thorough 51 evaluation of any device is essential before purchasing decisions are made.29,30 52 Similarly, the HSE identifies that the end-users of any safer sharps device should be 53 involved in assessing user acceptability and clinical applicability of any needle safety 54 devices.31 The evaluation should ensure that the safety feature works effectively and 55

55

reliably, that the device is acceptable to healthcare practitioners and that it does not 1 adversely affect patient care. 2 3 4 SP41 Use safety sharps devices where there are clear

indications that they will provide safe systems of working for healthcare practitioners. [Revised wording]

Class C/ H&S

5 SP42 Evaluate the use of safety sharps devices to determine

their effectiveness, acceptability to practitioners, impact on patient care and cost benefit, prior to widespread introduction. [Revised wording]

Class D/ GPP/ H&S

References 6 1. Department of Health. An organisation with a memory. London: Stationery Office; 2000. 7 2. NHS Employees. The Management of Health Safety and Welfare: Issues for NHS staff. London: 8

Stationery Office; 2005. 9 3. ECRI. Sharps safety and needlestick prevention. 2nd edition. Plymouth: 2003. Available at: 10

http://www.ecri.org (Accessed 4 June 2013). 11 4. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 12

epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 13 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 14

5. Asai T, Hidaka I, Kawashima A, Miki T, Inada K, Kawachi S. Efficacy of catheter needles with 15 safeguard mechanisms. Anaesthesia 2002; 57: 572-577. 16

6. Sohn S, Eagan J, Sepkowitz, K A., Zuccotti G. Effect of implementing safety- engineered devices 17 on percutaneous injury epidemiology. Infect Control Hosp Epidemiol 2004; 25(7): 536-42. 18

7. Alvarado-Ramy F, Beltrami EM, Short LJ, Srivastava PU, Henry K, Mendleson M, Gerberding JL, 19 Delclos GL, Campbell S, Solomon R, Fahrner R, Culver DH, Bell D, Cardo DM, Chamberland ME. 20 A comprehensive approach to percutaneous injury prevention during phlebotomy: Results of a 21 multicenter study, 1993-1995. Infect Control Hosp Epidemiol 2003; 24(2): 97-104. 22

8. Rogues A M, Verdun-Esquer C, Buisson-Valles I, Laville MF, Lasheras A, Sarrat A, Beaudelle H, 23 Brochard P, Gachie JP. Impact of safety devices for preventing percutaneous injuries related to 24 phlebotomy procedures in health care workers. Am J Infect Control 2004; 32(8): 441-4. 25

9. Mendelson MH, Lin-Chen BY, Solomon R, Bailey E, Kogan G, Goldbold J. Evaluation of a safety 26 resheathable winged steel needle for prevention of percutaneous injuries associated with 27 intravascular-access procedures among healthcare workers [see comment]. Infect Control Hosp 28 Epidemiol 2003; 24(2): 105-12. 29

10. Adams D, Elliott TSJ. A comparative user evaluation of three needle-protective devices. Br J Nurs 30 2003; 12(8): 470-474. 31

11. Cullen BL, Genasi F, Symington I, Bagg J, McCreadie M, Taylor A, Henry M, Hutchinson SJ, 32 Goldberg D. Potential for reported needlestick injury prevention among healthcare workers through 33 safety devices usage and improvement of guideline adherence: expert panel assessment. J Hosp 34 Infect 2006; 63: 445-451. 35

12. Centers for Disease Control. Evaluation of safety devices for preventing percutaneous injuries 36 among health care workers during phlebotomy procedures- Minneapolis-St Paul, New York City, 37 and San Francisco, 1993-1995. MMWR 1997; 46(2): 21-25. 38

13. NICE. Infection: Prevention and control of healthcare associated infections in primary and 39 community care. Clinical guideline, methods, evidence and recommendations. Partial update of 40 NICE clinical guideline 2. 2012. Available at: 41 http://www.nice.org.uk/nicemedia/live/13684/58654/58654.pdf (Accessed 4 June 2013). 42

14. HSE. An evaluation of the efficacy of safer sharps devices. Systematic Review 2012. Available at: 43 http://www.hse.gov.uk/research/rrpdf/rr914.pdf (Accessed 4 June 2013). 44

15. Sullivan S, Williamson B, Wilson LK, Korte JE, Soper D. Blunt needles for the reduction of 45 needlestick injuries during cesarean delivery: a randomized controlled trial. Obstet Gynecol 2009; 46 114 (2): 211-216. 47

16. Hotaling M. A retractable winged steel (butterfly) needle performance improvement project: Jt 48 Comm J Qual Patient Saf 2009; 35 (2): 100-105. 49

17. Valls V, Lozano MS, Yanez R, Martinez MJ, Pascual F, Lloret J, Ruiz JA. Use of safety devices and 50 the prevention of percutaneous injuries among healthcare workers. Infect Control Hosp Epidemiol 51 2007; 28 (12): 1352-1360. 52

56

18. Lamontagne F, Abiteboul D, Lolom I, Pellissier G, Tarantola A, Descamps JM, Bouvet E. Role of 1 safety-engineered devices in preventing needlestick injuries in 32 French hospitals. Infect Control 2 Hosp Epidemiol 2007; 28 (1): 18-23. 3

19. Azar-Cavanagh M, Burdt P, Green-McKenzie J. Effect of the introduction of an engineered sharps 4 injury prevention device on the percutaneous injury rate in Healthcare workers. Infect Control Hosp 5 Epidemiol 2007; 28(2): 165-170. 6

20. Sohn S, Eagan J, Sepkowitz KA. Safety-engineered device implementation: does it introduce bias 7 in percutaneous injury reporting? Infect Control Hosp Epidemiol 2004; 25 (7): 543-547. 8

21. McCleary J, Caldero K, Adams T. Guarded fistula needle reduces needlestick injuries in 9 hemodialysis. Nephrol News Issues 2002; 16 (6): 66-70. 10

22. Zakrzewska JM, Greenwood I, Jackson J. Introducing safety syringes into a UK dental school--a 11 controlled study. Br Dent J 2001; 190(2): 88-92. 12

23. Rogers B, Goodno L. Evaluation of interventions to prevent needlestick injuries in health care 13 occupations. Am J Prev Med 2000; 18 (4 Suppl): 90-98. 14

24. Reddy SG, Emery RJ Assessing the effect of long-term availability of engineering controls on 15 needlestick injuries among health care workers: a 3-year pre-implementation and post-16 implementation comparison. Am J Infect Control 2001; 29 (6): 425-427. 17

25. Prunet B, Meaudre E, Montcriol A, Asencio Y, Bordes J, Lacroix G, Kaiser E. A prospective 18 randomized trial of two safety peripheral intravenous catheters. Anesth Analg 2008; 107 (1): 155-19 158. 20

26. Bamberg R, Rivers C, Moore C. Use of needle safety devices by clinical laboratories in North 21 Carolina hospitals. Clin Leadersh Manag Rev 2003; 17 (1): 21-25. 22

27. Casey AL, Elliott TS. The usability and acceptability of a needleless connector system. Br J Nurs 23 2007; 16(5): 267-271. 24

28. Clarke SP, Rockett JL, Sloane DM, Aiken LH. Organizational climate, staffing, and safety 25 equipment as predictors of needlestick injuries and near misses in hospital nurses. Am J Infect 26 Control 2002; 30 (4): 207-216. 27

29. Occupational Safety and Health Administration. Enforcement procedures for the occupational 28 exposure to bloodborne pathogens. Directive number CPL2-2.44D. 1999. p.69. 29

30. National Institute for Occupational Safety and Health. Preventing Needlestick Injuries in Health 30 Care Settings. Cincinnati: DHHS (NIOSH); 1999. 31

31. Health and Safety Executive. Health and Safety (Sharp Instruments in Healthcare) Regulations 32 2013 Guidance for employers and employees Health Services Infromation Sheet 7.March 2013. 33 Available at: www.hse.gov.uk/pubns/hsis7.htm (Accessed 4 June 2013).34

57

2.6 Asepsis 1 2 3 Asepsis can be defined as the purposeful prevention of the transfer of potentially 4 pathogenis miscroorganisms1 and is an essential component in the prevention of 5 HCAI, particularly those associated with the insertion and maintenance of invasive 6 devices and the management of non-intact skin and wounds. The principles of 7 aseptic technique are based on a priori scientific knowledge about the way in which 8 microorganisms can be transferred and about the susceptibility of unwell individuals, 9 who have compromised immune systems or body defences, due to injury or 10 healthcare intervention, e.g. surgery or the insertion of a medical device.2 11 12 The main principle of an aseptic technique is that a susceptible site, e.g. a wound or 13 invasive device, should not come into contact with any item that is not sterile and that 14 any items of equipment that have been in contact with a susceptible site should be 15 disposed of safely or decontaminated.2 Aseptic technique should be used for the 16 insertion and manipulation of any sterile medical device. When conducting an 17 aseptic procedure ensure that: 18 19

sterile packs are placed on clean surfaces; 20 all the materials and fluids in contact with the susceptible site are sterile and 21

packs/ containers are undamaged; 22 hands are decontaminated immediately prior to the procedure or the donning 23

of gloves; 24 sterile gloves are used where susceptible body sites will be touched or a 25

sterile invasive device manipulated; 26 items that become contaminated during the procedure are discarded and 27

replaced with new sterile items, e.g. gloves, fluids or containers.3 28 29 30 SP43 Use an aseptic technique for all procedures that

entail contact with a susceptible site or sterile invasive device. [New recommendation]

Class D/ GPP

31 References 32 1. Crow S. Asepsis, the right touch. Something old is now new. 1989. The Everett Companies. 33

Louisiana. 34 2. Wilson J. Infection Control in Clinical Practice. 2006. Bailliere Tindall Elsevier. London. 35 3. Royal College of Physicians. Healthcare Associated Infections Working Group. RCP Insight 36

Principles of aseptic technique - Top Ten Tips. HAIWG/0003/03/2011 available at: 37 http://www.rcplondon.ac.uk/sites/default/files/top-ten-tips-principles-of-aseptic-technique.pdf 38 Accessed 6 June 2013. 39

40 41 42 43 44

45

58

SECTION 3 1 2 GUIDELINES FOR PREVENTING INFECTIONS ASSOCIATED 3 WITH THE USE OF SHORT-TERM INDWELLING URETHRAL 4 CATHETERS 5

6

59

Section 3 - Guidelines for preventing infections 1 associated with the use of short-term indwelling 2 urethral catheters 3

4 5 3.1 Introduction 6 This guidance is based on the best critically appraised evidence currently available. 7 The type and class of supporting evidence explicitly linked to each recommendation 8 is described. All recommendations are endorsed equally and none is regarded as 9 optional. These recommendations are not detailed procedural protocols and need to 10 be incorporated into local guidelines. 11 12 These guidelines apply to adults and children aged one year and older who require a 13 short term indwelling urethral catheter (28 days or less), and should be read in 14 conjunction with the guidance on Standard Principles. The recommendations are 15 divided into six distinct interventions: 16 17

1. Assessing the need for catheterisation; 18 2. Selection of catheter type and system; 19 3. Catheter insertion; 20 4. Catheter maintenance; 21 5. Education of patients, relatives and healthcare workers and; 22 6. System interventions for reducing the risk of infection. 23

24

3.2 Background and context of the Guidelines 25 Urinary tract infection (UTI) is the most common infection acquired as a result of 26 healthcare, accounting for 19% of HCAI, with between 43 to 56% of these UTI 27 associated with a urethral catheter.1,2 Catheter predisposes to infection because 28 microorganisms are able to bypass natural host mechanisms such as the urethra and 29 micturition and gain the entry to the bladder.3 Most microorganisms causing these 30 catheter associated urinary tract infection (CAUTI) gain access to the urinary tract 31 either extraluminally or intraluminally. Extraluminal contamination may occur as the 32 catheter is inse33

34 thought to occur by microorganisms ascending from the perineum. Intraluminal 35 contamination occurs by reflux of microorganisms from a contaminated urine 36 drainage bag.4 37 38 The bladder is normally sterile and in the non-catheterised patient a UTI is usually 39 readily identified from the symptoms of dysuria and frequency. Patients who develop 40 a UTI with an indwelling catheter in place will not experience these symptoms, and 41 diagnosis is based on other signs such as fever, suprapubic or loin tenderness.5 After 42 a few days of catheterisation microorganisms may be isolated from urine and, in the 43 absence of any symptoms of UTI this is called bacteriuria.6 The duration of the 44 catheterisation is the dominant risk factor for (CAUTI) and virtually all catheterised 45 patients develop bacteriuria within one month. For the purpose of these guidelines a 46 duration of catheterisation of 28 days or less is considered to be a short-term 47 catheterisation.4 48 49

60

Several fators contribute to the potential development of CAUTI including the 1 formation of biofilms and encrustation of the catheter. Bacteria on the catheter 2 surface and drainage bag multiply rapidly, adhering to the surface by excreting 3 extracellular polysaccharides and forming a layer known as biofilm. Bacteria within 4 the biofilm are morphologically and physiologically different from free-living planktonic 5 bacteria in the urine, and have considerable survival advantages as they are 6 protected from the action of antibiotic therapy4. 7 8 Whilst biofilms commonly form on devices inserted into the body, they can cause 9 additional problems on urethral catheters if the bacteria produce the enzyme urease, 10 such as Proteus mirabilis.4 This enzyme causes the urine to become alkaline 11 inducing crystallisation of calcium and magnesium phosphate within the urine. These 12 crystals are incorporated into the biofilm and over time result in encrustation of the 13 catheter. Encrustation is generally associated with long-term catheterisation, as it has 14 a direct relationship with the length of catheterisation.4 15 16 Urinary catheterisation is a frequent intervention during clinical care in hospital 17 affecting a significant number of patients. It has been estimated that 15 to 25% 18 hospitalised patients receive urinary catheter during their stay.7-10 This number is 19 much higher in ICU/ITU where most patients are catheterised.11 The risk of infection 20 is associated with the method and duration of catheterisation, the quality of catheter 21 care and patient susceptibility.12 Between 20% and 30% of catheterised patients 22 develop bacteriuria, of whom 2-6% percent develop symptoms of CAUTI. 12 23 Approximately 3% of those with CAUTI develop life threatening secondary infections 24 such as bacteraemia or sepsis, where mortality rates range from 10% to 33%. 13,14 25 CAUTI is associated with prolonged hospitalisation, readmissions and increased 26 mortality.15 Those particularly at risks are immunocompromised, elderly, debilitated 27 and patients with diabetes.16 28 29 Physical and psychological discomfort associated with insertion, removal and the 30 catheter in situ are common.17 Complications such as inflammation, urethral 31 strictures, mechanical trauma, bladder calculi and inflammation of renal system also 32 occur.18-20 Urine retention after catheter removal is also a frequent occurrence.21 In 33 some instances, especially in older people, CAUTI may also contribute to falls and 34 delirium.22 The treatment of both CAUTI and other infection sequelae contribute to 35 the emerging problem of antibiotic resistance in hospitals and uropathogens are a 36 major source of antimicrobial resistant organisms.24,24 37 38 CAUTI also affects the costs of healthcare due to delayed discharge from hospital, 39 treatment and staff resources. The financial burden of CAUTI on NHS has been 40 estimated as £99 million/year with estimated cost per episode of £1968.25,26 However, 41 there are no robust economic assessments of the cost of CAUTI. 42 43 44 References 45

1 Health Protection Agency. English National Point Prevalence Survey on Healthcare Associated 46 Infections and Antimicrobial Use, 2011: Preliminary data. 2012. 47

2 Smyth ET, McIlvenny G, Enstone JE, Emmerson AM, Humphreys H, Fitzpatrick F, et al. Four 48 country healthcare associated infection prevalence survey 2006: overview of the results. J 49 Hosp Infect 2008 Jul; 69(3): 230-248. 50

3 Department of Health. Essential steps to safe, clean care urinary catheter care. 2006. 51 4 Chenoweth C, Saint S. Preventing catheter-associated urinary tract infections in the intensive 52

care unit. Crit Care Clin 2013; 29(1): 19-32. 53

61

5 Johnson, JR, Kuskowski MA, Wilt TJ. Systematic review: antimicrobial urinary catheters to 1 prevent catheter-associated urinary tract infection in hospitalized patients. Ann Intern Med 2 2006; 144(2): 116. 3

6 Parker D, Callan L, Harwood J, Thompson DL, Wilde M, Gray M. Nursing interventions to 4 reduce the risk of catheter-associated urinary tract infection. Part 1: Catheter selection. 5 JWOCN 2009; 36(1): 23-34. 6

7 Warren JW. Catheter-associated urinary tract infections. Int J Antimicrob Agents 2001;17(4): 7 299-303. 8

8 Saint S, Wiese J, Amory J, Bernstein M, Patel U, Zemencuk J, et al. Are physicians aware of 9 which of their patients have indwelling urinary catheters? Am J Med 2000; 109(6): 476-480. 10

9 Munasinghe RL, Yazdani H, Siddique M, Hafeez W. Appropriateness of Use of Indwelling 11 Urinary Catheters in Patients Admitted to the Medical Service. Infect Control Hosp Epidemiol 12 2001; 22(10): 647-649. 13

10 Jain P, Parada J, David A, Smith L. Overuse of the indwelling urinary tract catheter in 14 hospitalized medical patients. Arch Intern Med 1995; 155(13): 1425-1429. 15

11 Burton DC, Edwards JR, Srinivasan A, Fridkin SK, Gould CV. Trends in catheter-associated 16 urinary tract infections in adult intensive care units-United States, 1990-2007. Infect Control 17 Hosp Epidemiol 2011; 32(8): 748-756. 18

12 Stamm W. Urinary Tract Infections. In: Bennett J, Brachman P, editors. Hospital Infection 4th 19 ed. Philadelphia: Lippincott-Raven; 1998. p.477-485. 20

13 Shuman E. Recognition and prevention of healthcare-associated urinary tract infections in the 21 intensive care unit. Crit Care Med 2010; 38(Suppl 1): S373-S379. 22

14 Chang R, Todd Greene M, Chenoweth CE, Kuhn L, Shuman E, Rogers MAM, et al. 23 Epidemiology of Hospital-Acquired Urinary Tract Related Bloodstream Infection at a University 24 Hospital. Infect Control Hosp Epidemiol 2011; 32(11): 1127-1129. 25

15 Beattie M, Taylor J. Silver alloy vs. uncoated urinary catheters: a systematic review of the 26 literature. J Clin Nurs 2011; 20(15-16): 2098-2108. 27

16 Ha U, Cho Y. Catheter-associated urinary tract infections: new aspects of novel urinary 28 catheters. Int J Antimicrob Agents 2006; 28(6): 485-490. 29

17 Bernard MS, Hunter KF, Moore KN. A review of strategies to decrease the duration of 30 indwelling urethral catheters and potentially reduce the incidence of catheter-associated urinary 31 tract infections. Urol Nurs 2012; 32(1): 29. 32

18 Saint S, Savel RH, Matthay MA. Enhancing the safety of critically ill patients by reducing 33 urinary and central venous catheter-related infections. Am J Respir Crit Care Med 2002; 34 165(11): 1475-1479. 35

19 Talja M, Korpela A, Järvi K. Comparison of urethral reaction to full silicone, hydrogen-coated 36 and siliconised latex catheters. Br J Urol 1990; 66(6): 652-657. 37

20 Robertson GSM, Everitt N, Burton PR, Flynn JT. Effect of Catheter Material on the Incidence of 38 Urethral Strictures. Br J Urol 1991; 68(6): 612-617 39

21 Crowe H, Clift R, Duggan G, Bolton DM, Costello AJ. Randomised Study of the Effect of 40 Midnight versus 0600 Removal of Urinary Catheters. Br J Urol 1993; 71(3): 306-308. 41

22 Hazelett S, Tsai M, Gareri M, Allen K. The association between indwelling urinary catheter use 42 in the elderly and urinary tract infection in acute care. BMC Geriatr 2006; 6(1): 15-15. 43

23 Tambyah PA. Catheter-associated urinary tract infections: diagnosis and prophylaxis. Int J 44 Antimicrob Agents 2004; 24: 44-48. 45

24 Curran E, Murdoch M. Aiming to reduce catheter associated urinary tract Infections (CAUTI) by 46 adopting a checklist and bundle to achieve sustained system improvements. J Infect Prev 47 2009; 10(2): 57-61. 48

25 Davenport K, Keeley FX. Evidence for the use of silver-alloy-coated urethral catheters. J Hosp 49 Infect 2005 8; 60(4): 298-303. 50

26 Ward L, Fenton K, Maher L. The high impact actions for nursing and midwifery: protection from 51 infection. Nurs Times 2010; 106(31): 20-21.52

62

3.3 Assessing the need for catheterisation 1 2 3 Catheters place patients at significant risk of acquiring a urinary tract infection. 4 The longer a catheter is in place, the greater the danger 5 There is a strong association between the duration of catheterisation and risk of 6 infection, i.e., the longer the catheter is in place, the higher the incidence of urinary 7 tract infection1,2,3. In acute care facilities, 20-30% of catheterised patients develop 8 bacteriuria, with the risk approximately 5 percent for each day of catheterisation1,4,5. 9 Between 2 and 6% of bacteriuric patients with develop CAUTI and of these, 1-4 10 percent develop a bloodstream infection. 11  12 Advice from best practice emphasises the importance of documenting all procedures 13 involving the catheter or drainage system in the patient's records6 and providing 14 patients with adequate information in relation to the need for catheterisation and 15 details of the insertion procedures, maintenance and removal of their catheter6,7. 16 There is some evidence to suggest that computer management systems improve 17 documentation and in so doing reduce the duration of catheterisation8. 18 19 What are the indications for using a short-term urinary catheter? 20 The use of a short-term urethral catheter is appropriate in patients with acute urinary 21 retention or obstruction, those who require precise urine output measures to monitor 22 an underlying condition, patients undergoing certain surgical procedures, especially 23 with prolonged duration and urological procedures. Furthermore, an indwelling 24 catheter may be appropriate to improve patient comfort during end-of life care or in 25 the management of open sacral or perineal wounds when the patient is incontinent.9 26 27 While the use of the urinary catheter is sometimes unavoidable, there is evidence 28 that catheters are inserted without a clear clinical indication, clinicians are not always 29 aware they are in situ, and they are not removed promptly when no longer 30 required.10,11 Using an indwelling urethral catheter only when necessary and after 31 considering alternatives, and ensuring the catheter is removed as soon as possible 32 are simple and effective methods to preventing CAUTI. Interventions that prompt or 33 facilitate the removal of unnecessary catheters may therefore reduce the risk of 34 CAUTI. These interventions have been categorised as reminder systems, which 35 remind clinicians that the catheter is in place and removal should be considered, or 36 stop orders that indicate that catheters should be removed after a set period of time 37 or when defined clinical criteria have been met.8,12-14 38 39 A well-conducted SR of 14 studies (one RCT, one NRCT, three controlled before-40 after (CBA) and nine uncontrolled before after studies) on reminder and stop order 41 systems found that these interventions significantly decreased the rate of CAUTI and 42 did not increase the need for re-catheterisation, although as some of the studies 43 were not controlled, they were susceptible to bias in favour of the intervention.12 44 45 A second SR identified a number of uncontrolled before after studies that used 46 ultrasound bladder scanners to assess for urinary retention and support appropriate 47 catheterisation. When used in combination with guidelines16, insertion checklist/kit, 48 education, audit and feedback17 and reminder/stop orders18, ultrasound bladder 49 scanners were found to decrease the use of urethral catheters by between 5 and 50 15%. 15  51 52 53 54

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UC1 Only use an indwelling urethral catheter in patients for whom it is clinically indicated and following the assessment of alternative methods. [Revised recommendation]

Class D/ GPP

UC2 Document the clinical indication(s) for catheterisation,

date of insertion, expected duration, type of catheter inserted and planned date of removal. [Revised recommendation]

Class D/ GPP

UC3 Assess and document each day of the clinical need for

continuing catheterisation and ongoing care. Remove the catheter when no longer clinically indicated. [Revised recommendation]

Class D/ GPP

 1 References 2

1 Stamm W. Urinary Tract Infections. In: Bennett J, Brachman P, editors. Hospital Infection. 4th 3 ed. Philadelphia: Lippincott-Raven; 1998. p.477-485. 4

2 Saint S, Lipsky B. Preventing catheter-related bacteriuria: should we? Can we? How? Arch 5 Intern Med 1999; 159(8): 800-808. 6

3 Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. 7 Am J Med 2002; 113(1, Supplement 1): 5-13. 8

4 Garibaldi R, Mooney B, Epstein B, Britt M. An evaluation of daily bacteriologic monitoring to 9 identify preventable episodes of catheter-associated urinary tract infections. Infect Control 10 1982; 3: 466-70. 11

5 5. Garibaldi RA, Burke JP, Britt MR, Miller WA, Smith CB. Meatal Colonization and Catheter-12 Associated Bacteriuria. N Engl J Med 1980 08/07; 2013; 303(6): 316-318. 13

6 Ward L, Fenton K, Maher L. The high impact actions for nursing and midwifery: protection from 14 infection. Nurs Times 2010; 106(31): 20-21. 15

7 Wong ES. Guideline for prevention of catheter-associated urinary tract infections. Am J Infect 16 Control 1983 2; 11(1): 28-33. 17

8 Cornia PB, Amory JK, Fraser S, Saint S, Lipsky BA. Computer-based order entry decreases 18 duration of indwelling urinary catheterization in hospitalized patients. Am J Med 2003; 114(5): 19 404-407. 20

9 Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA, Healthcare Infection Control 21 Practices Advisory Committee. Guideline for Prevention of Catheter-Associated Urinary Tract 22 Infections 2009. Infect Control Hosp Epidemiol 2010; 31(4): 319-326. 23

10 Saint S, Wiese J, Amory J, Bernstein M, Patel U, Zemencuk J, et al. Are physicians aware of 24 which of their patients have indwelling urinary catheters? Am J Med 2000; 109(6): 476-480. 25

11 Fakih MG, Dueweke C, Meisner S, Berriel-Cass D, Savoy-Moore R, Brach N, et al. Effect of 26 nurse-led multidisciplinary rounds on reducing the unnecessary use of urinary catheterization in 27 hospitalized patients. Infect Control Hosp Epidemiol 2008; 29(9): 815-819. 28

12 Meddings J, Rogers MAM, Macy M, Saint S. Systematic Review and Meta-Analysis: Reminder 29 Systems to Reduce Catheter-Associated Urinary Tract Infections and Urinary Catheter Use in 30 Hospitalized Patients. Clin Infect Dis 2010; 51(5): 550-560. 31

13 Loeb M, Hunt D, O'Halloran K, Carusone SC, Dafoe N, Walter SD. Stop orders to reduce 32 inappropriate urinary catheterization in hospitalized patients: a randomized controlled trial. J 33 Gen Intern Med 2008; 23(6): 816-820. 34

14 Stéphan F, Sax H, Wachsmuth M, Hoffmeyer P, Clergue F, Pittet D. Reduction of Urinary Tract 35 Infection and Antibiotic Use after Surgery: A Controlled, Prospective, Before-After Intervention 36 Study. Clin Infect Dis 2006; 42(11): 1544-1551. 37

15 Murphy, C., Fader, M. & Prieto, J. Interventions to minimise the initial use of indwelling urinary 38 catheters in acute care: A systematic review. Int J Nurs Stud 2013:(in press). 39

16 Slappendel, R. & Weber, E. Non-invasive measurement of bladder catheterization after 40 orthopaedic surgery and its effect on urinary tract infections. Eur J Anaesthesiol, 1999: 16(8): 41 503-506. 42

64

17 Patrizzi, K., Fasnacht, A. & Manno, M. A collaborative, nurse-driven initiative to reduce 1 hospital-acquired urinary tract infections. J Emerg Nurs 2009; 35(6): 536-539. 2

18 Topal J, Conklin S, Camp K, Morris V, Balcezak T, Herbert P. Prevention of Nosocomial 3 Catheter-Associated Urinary Tract Infections Through Computerized Feedback to Physicians 4 and a Nurse-Directed Protocol. Am J Med Qual 2005 May; 20(3): 121-126. 5

6 3.4 Selection of a catheter type 7 8 Is one catheter better than another? 9 Evidence from best practice indicates that the incidence of CAUTI in patients 10 catheterised for a short time (up to one week) is not influenced by any particular type 11 of catheter material1,2. However, many practitioners have strong preferences for one 12 type of catheter over another. This preference is often based on clinical experience, 13 patient assessment, and materials that induce the least allergic response. Smaller 14 gauge catheters with a 10 ml balloon minimise urethral trauma, mucosal irritation and 15 residual urine in the bladder, all factors that predispose to CAUTI3,4. However, in 16 adults that have recently undergone urological surgery, larger gauge catheters may 17 be indicated to allow for the passage of blood clots. Our previous evidence based 18 guidelines5 identified three experimental studies that compared the use of latex with 19 silicone catheters6-8. No significant difference in the incidence of bacteriuria was 20 found. 21 22 We identified one new SR that included three trialscomparing different types of 23 standard (non-antiseptic/antimicrobial impregnated) catheters. These studies did not 24 provide sufficient evidence to suggest that one type of catheter may be more 25 effective than another in preventing bacteriuria.9-12 However, there is a risk of urethral 26 trauma associated with using a female catheter in a male patient and systems should 27 be in place to ensure this does not occur.13 28 29 In our previous SR we found evidence related to the efficacy of using urinary 30 catheters coated or impregnated with antiseptic or antimicrobial agents from four SRs 31 and one meta-analysis that have examined this issue.14-19 In general, all of these five 32 studies suggested antiseptic impregnated or antimicrobial-coated urinary catheters 33 can significantly prevent or delay the onset of CAUTI when compared to standard 34 untreated urine catheters. The consensus in these five reviews of evidence however, 35 is that the individual studies reviewed are generally of poor quality; for instance in 36 one case17 only eight studies out of 117 met the inclusion criteria and in another, of 37 the six reports describing seven trials included, only one scored five in the quality 38 assessment the other five scored only one.19 The studies included in these reviews 39 investigated a wide range of coated or impregnated catheters including: catheters 40 coated or impregnated with: silver alloy,15,17,19-26; silver oxide17; gendine27; 41 gentamicin28 and silver-hydrogel29-31; minocycline31; rifampicin32; chlorhexidine silver 42 sulfadiazine31; chlorhexideine-sulfadiazine-triclosan31; nitrofurazone31; and 43 nitrofuroxone.33 Four studies compared the use of silver coated (silver alloy or silver 44 oxide) catheters with silicone, hydrogel or Teflon® latex.34-37 A SR and meta-analysis 45 of these and other studies found that silver alloy (but not silver oxide) catheters were 46 associated with a lower incidence of bacteriuria.17,38 Despite their unit cost, these 47 devices may provide a a cost-effective option if overall numbers of infections are 48 significantly reduced through their use. However, the few studies that have explored 49 the cost benefit / effectiveness of using these devices have however, also been 50 inconclusive.22,24,26,39 51 52 We identified two new SR of the efficacy of silver coated or antimicrobial impregnated 53 catheters in preventing CAUTI.9,16 The first SR included 22 RCT as well as one 54 NRCT, and concluded that silver coated (alloy or oxide) indwelling catheters for 55

65

short-term catheterisation reduced the risk of bacteriuria but did not demonstrate an 1 effect on CAUTI.9 Catheters impregnated with antimicrobial agents (minocycline, 2 rifampicin or nitrofurazone) were found to reduce the rate of bacteriuria during the 3 first week of catheterisation but not for catheter durations of greater than a week. 4 Although antimicrobial impregnated catheters reduced the risk of CAUTI, the number 5 of cases was too small to demonstrate a significant effect. 6 7 The second SR included nine RCTs and 3 quasi-experimental studies and concluded 8 that, compared to standard catheters, both nitrofurazone impregnated and silver alloy 9 coated catheters can both prevent and delay the onset of bacteriuria during short 10 term use, however there was no data on the risk of CAUTI.16 11 12 We identified one high-quality multicentre RCT that compared silver alloy and 13 nitrofurazone impregnated catheters with standard Teflon® coated latex for short-14 term catheterisation.40 Although the nitrofurazone and silver alloy catheters were 15 associated with a reduced risk of CAUTI (adjusted OR 0.81; 95%CI 0.66 -1.01and 16 0.96; 95%CI 0.78-1.19 respectively) compared to the Teflon® coated latex, the effect 17 was not considered to be clinically effective at this level. The nitrofurazone, but not 18 the silver alloy catheter, was associated with significantly lower incidence of 19 bacteriuria (OR 0.68; 95%CI 0.48-0.99, p=0.017). However, the nitrofurazone 20 impregnated catheter was associated with increased discomfort during the period the 21 catheter was in place. A limitation of this study is that the median duration of 22 catherisation was two days (range 1 to 3 days) and the risk of CAUTI associated with 23 this short period is correspondingly low. However, UTI developing up to six weeks 24 post randomisation were included in the outcome measurement, even though they 25 may not have been directly associated with the catheterisation. The economic 26 analysis suggested that nitrofurazone-impregnated but not silver-alloy catheters may 27 be cost effective, however the measures of cost were associated with a large amount 28 of uncertainty. 29 30 31 UC4

of: Latex allergy; Length of catheter (male, female, paediatric); Type of drainage: bag (urometer, 2 litre bag, leg;

bag) or catheter valve; Comfort and dignity.

[New recommendation]

Class D/ GPP

UC5 Select a catheter that minimizes urethral trauma, irritation and discomfort and is appropriate for the anticipated duration of short-term catheterisation. [Revised wording]

Class D/ GPP

UC6 Select the smallest gauge catheter that will allow free

urinary outflow and use a 10 ml retention balloon. Urological patients may require larger gauge sizes and balloons. [Revised wording]

Class D/ GPP

32

66

References 1 1 Pomfret IJ. Continence clinic. Catheters: design, selection and management. Brit J Nurs 1996; 5: 2

245-251. 3 2 Kunin CM. Urinary Tract Infections: Detection, Prevention, and Management 5th Ed. Baltimore MD: 4

Williams and Wilkins; 1997; 260-261. 5 3 Dieckhaus KD, Garibaldi RA. Prevention of Catheter-Associated Urinary Tract Infections. In: 6

Abrutytn E, Goldmann DA, Scheckler WE (eds). Saunders Infection Control Reference Service. 7 Philadelphia: W.B. Saunders Co.; 1998; 169-174. 8

4 Roe BH, Brocklehurst JC. Study of patients with indwelling catheters, J Adv Nurs 1987; 12: 713-9 718. 10

5 Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 11 team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 12 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 13 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 14 Hospital-acquired Infections. J Hosp Infect 2001;47(Supplement):S1-S-82. Available at: 15 http://www.richardwellsresearch.com (Accessed 7 June 2013). 16

6 Lopez-Lopez G, Pascual A, Martinez-Martinez L, Perea EJ. Effect of a siliconised latex urinary 17 catheter on bacterial adherence and human neutrophil activity. Diagn Microbiol and Infect Dis 18 1991; 14: 1-6. 19

7 Nickel JC, Feero P, Costerton JW, Wilson E. Incidence and importance of bacteriuria in 20 postoperative short-term urinary catheterisation. Can J Surg 1989; 32: 131-132. 21

8 Talja M, Korpela A, Jarvi K. Comparison of urethral reaction to full silicone, hydrogen-coated and 22 siliconised latex catheters. Brit J Urol 1990; 66: 652-657. 23

9 Schumm, K. & Lam, T. (2010) Types of urethral catheters for management of short-term voiding 24 problems in hospitalized adults: a short version Cochrane Review. SLJOG, 31(2). 25

10 Chene G, Boulard G, Gachie JP. A controlled trial of a new material for coating urinary catheters 26 ouveau materiau pour enduire les sondes urnaires]. Agressologie 1990; 31(8): 27

499 501. 28 11 Nickel JC, Feero P, Costerton W, Wilson E. Incidence and importance of bacteriuria in 29

postoperative, short-term urinary catheterization. Can J Surg 1989; 32(2): 131 2. 30 12 Tidd MJ, Gow JG, Pennington JH, Shelton J, Scott MR. Comparison of hydrophilic polymer-coated 31

latex, uncoated latex and PVC indwelling balloon catheters in the prevention of urinary infection. Br 32 J Urol 1976; 48: 285 91. 33

13 National Patient Safety Agency Rapid response Report: Female urinary catheters causing trauma 34 to adult males. NSPCA/2009/RRR02. National Patient Safety Agency 2009. 35

14 Pellowe CM, Pratt RJ, Loveday HP, Harper P, Robinson N, Jones SRLJ. The epic project. Updating 36 the evidence-base for national evidence-based guidelines for preventing healthcare-associated 37 infections in NHS hospitals in England: a report with recommendations. Brit J Infect Control 2004; 38 5(6): 10-15. Available at: http://www.richardwellsresearch.com 39

15 Brosnahan J, Jull A, Tracy C. Types of urethral catheters for management of short-term voiding 40 problems in hospitalised adults. (Cochrane Review). The Cochrane Library 2004; (Issue 1), John 41 Wiley and Sons: Chichester. 42

16 Johnson JR, Kuskowski MA, Wilt TJ. Systematic Review: Antimicrobial Urinary Catheters To 43 Prevent Catheter-Associated Urinary Tract Infection in Hospitalized Patients. Ann Intern Med 2006; 44 144: 116-126. 45

17 Saint S, Elmore JG, Sullivan SD, Emerson SS, Koepsell TD. The efficacy of silver alloy coated 46 catheters in preventing urinary tract infection: a meta-analysis. Am J Med 1998; 105: 236-241. 47

18 Dunn S, Pretty L, Reid H, Evans D. Management of short term indwelling urethral catheters to 48 prevent urinary tract infections. A Systematic Review. Australia: The Joanna Briggs Institute for 49 Evidence Based Nursing and Midwifery. 2000; p.64. 50

19 Niel-Weise BS, Arend SM, van den Broek PJ. Is there evidence for recommending silver-coated 51 urinary catheters in guidelines? J Hosp Infect 2002; 52(2): 81-87. 52

20 Verleyen P, De Ridder D, Van Poppel H, Baert L. Clinical application of the Bardex IC Foley 53 Catheter. Eur Urol 1998; 36: 240-246. 54

21 Karchmer TB, Giannetta ET, Muto CA, Strain BA, Farr BM. A Randomized Crossover Study of 55 Silver-Coated Urinary Catheters in Hospitalized Patients. Arch Intern Med 2000; 160, 3294-3298. 56

67

22 Saint S, Veenstra DL, Sullivan SD, Chenoweth C, Fendrick M. The potential clinical and economic 1 benefits of silver alloy urinary catheters in preventing urinary tract infection. Arch Intern Med 2000; 2 160: 2670-2675. 3

23 Newton T, Still JM, Law E. A comparison of the effect of early insertion of standard latex and silver 4 impregnated latex Foley catheters on urinary tract infections in burn patients. Infect Control Hosp 5 Epidemiol 2002; 23(4): 217-218. 6

24 Gentry H, Cope S. Using silver to reduce catheter-associated urinary tract infections, Nurs Stand 7 2005; 19(50): 51-54. 8

25 Madeo M, Davies D, Johnson G, Owen E, Wadsworth P, Martin CR. The impact of using silver alloy 9 urinary catheters in reducing the incidence of urinary tract infections in the critical care setting. Br J 10 Infect Control 2004; 5(1): 21-24. 11

26 Rupp ME, Fitzgerald T, Marion N, Helget V, Puumala S, Anderson JR, Fey PD. Effect of silver-12 coated urinary catheters: efficacy, cost-effectiveness, and antimicrobial resistance. Am J Infect 13 Control 2004; 32(8): 445-50. 14

27 Chaiban G, Hanna H, Dvorak T, Raad I. A rapid method of impregnating endotracheal tubes and 15 urinary catheters with gendine: a novel antiseptic agent. J Antimicrob Chemother 2000; 55(1): 51-16 56. 17

28 Cho YW, Park JH, Kim SH, Cho Y H, Choi JM, Shin HJ, Bae YH, Chung H, Jeong SY, Kwon IC. 18 Gentamicin-releasing urethral catheter for short-term catheterization. J Biomater Sci Pol Ed 2003; 19 14(9): 963-972. 20

29 Thibon P, Le Coutour X, Leroyer R, Fabry J. Randomized multi-centre trial of the effects of a 21 catheter coated with hydrogel and silver salts on the incidence of hospital-acquired urinary tract 22 infections. J Hosp Infect 2000; 45: 117-124. 23

30 Lai KK. Use of silver-hydrogel urinary catheters on the incidence of catheter-associated urinary tract 24 infections in hospitalized patients. Am J Infect Control 2002; 30(4): 221-225. 25

31 Gaonkar TA, Sampath LA, Modak SM. Evaluation of the antimicrobial efficacy of urinary catheters 26 impregnated with antiseptics in an in vitro urinary tract model. Infect Control Hosp Epidemiol 2003; 27 24(7): 506-513. 28

32 Darouche RO, Smith JA, Hanna H, Dhabuwala CB, Steiner MS, Babaian RJ, Boone TB, Scardino 29 PT, Thornby JI, Raad II. Efficacy of Antimicrobial-Impregnated Bladder Catheters in Reducing 30 Catheter-Associated Bacteriuria: A Prospective, Randomized, Multicenter Clinical Trial. Urology 31 1999; 54(6): 976-981. 32

33 Al-Habdan I, Sadat-Ali M, Corea JR, Al-Othman A, Kamal BA, Shriyan DS. Assessment of 33 nosocomial urinary tract infections in orthopaedic patients: a prospective and comparative study 34 using two different catheters. Int Surg 2003; 88(3): 152-154. 35

34 Riley DK, Classen DC, Stevens LE, Burke JP. A large randomised clinical trial of a silver-36 impregnated urinary catheter: lack of efficacy and staphylococcal superinfection. Am J Med 1995; 37 98: 349-356. 38

35 Johnson JR, Roberts PL, Olsen RJ, Moyer KA, Stamm WE. Prevention of catheter-associated 39 urinary tract infection with a silver oxide-coated urinary catheter: clinical and microbiologic 40 correlates. J Infect Dis 1990; 162: 1145-150. 41

36 Liedberg H, Lundeberg T, Ekman P. Refinements in the coating of urethral catheters reduces the 42 incidence of catheter-associated bacteriuria. An experimental and clinical study. Eur Urol 1990; 17: 43 236-240. 44

37 Liedberg H, Lundeberg T. Silver alloy coated catheters reduce catheter-associated bacteriuria. Brit 45 J Urol 1990; 65: 379-381. 46

38 Saint S, Lipsky BA. Preventing catheter- related bacteriuria. Should we? Can we? How? Arch Int 47 Med 1999; 159: 800-808. 48

39 Cho YW, Park JH, Kim SH, Cho Y H, Choi JM, Shin HJ, Bae YH, Chung H, Jeong SY, Kwon IC. 49 Gentamicin-releasing urethral catheter for short-term catheterization. J Biomater Sci Pol 2003; 50 14(9): 963-972 51

40 Pickard, R., Lam, T., MacLennan, G., Starr, K., Kilonzo, M., McPherson, G., Gillies, K., McDonald, 52 A., Walton, K., Buckley, B., Glazener, C., Boachie, C., Burr, J., Norrie, J., Vale, L., Grant, A. & 53 N'Dow, J. (2012) Antimicrobial catheters for reduction of symptomatic urinary tract infection in 54 adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. 55 Lancet, 380(9857), p.1927-1935. 56

68

3.5 Catheter insertion 1 2 3 What technique should be used to insert a catheter? 4 In our previous review1 we found evidence from two SR2 which suggests that the use 5 of aseptic technique has not demonstrated a reduction in the rate of CAUTI. However 6 principles of good practice, clinical guidance3,4 and expert opinion5-11, together with 7 findings from another systematic review12 agree that urinary catheters must be 8 inserted using sterile equipment and an aseptic technique. 9 10 Expert opinion indicates that there is no advantage in using antiseptic preparations 11 for cleansing the urethral meatus prior to catheter insertion.5,10,13,14 Whilst there is low 12 quality evidence to suggest pre-lubrication of the catheter decreases the risk of 13 bacteriuria, it is also important to use lubricant or anaesthetic gel in order to minimise 14 urethral trauma and discomfort.13 There is no evidence suggesting a general benefit 15 of securing the catheter in terms of preventing the risk of CAUTI, but it is important in 16 order to minimise patient discomfort.13 Ensuring healthcare practitioners are trained 17 and competent in the insertion of urinary catheters will minimise trauma, discomfort 18 and the potential for CAUTI.3,5,9,11 19 20 Neither we, nor HICPAC guideline developers, identified any additional evidence of 21 acceptable quality whilst updating our systematic reviews. 22 23 24 UC7 Catheterisation is an aseptic procedure and should only

be undertaken by healthcare workers trained and competent in this procedure. [Revised wording]

Class D/ GPP

UC8 Clean the urethral meatus with sterile normal saline

prior to the insertion of the catheter. [No change]

Class D/ GPP

UC9 Use lubricant from a sterile single use container to minimize urethral discomfort, trauma and infection. Ensure the catheter is comfortably secured. [Revised wording]

Class D/ GPP

References 25 1 Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 26

epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 27 NHS Hospitals. J Hosp Infect 2007 January;65(1): supplement 1. 28

2 Dunn S, Pretty L, Reid H, Evans D. Management of short term indwelling urethral catheters to 29 prevent urinary tract infections. A Systematic Review. Australia: The Joanna Briggs Institute for 30 Evidence Based Nursing and Midwifery. 2000. p.64. 31

3 Ward V, Wilson J, Taylor L, Cookson B, Glynn A. Preventing Hospital-Acquired Infection: Clinical 32 Guidelines. London: Public Health Laboratory Service 1997; 25-29. 33

4 Wong ES, Hooton TM. Guideline for prevention of catheter-associated urinary tract infections. Am J 34 Infect Control 1983; 11(1): 28-36. 35

5 Dieckhaus KD, Garibaldi RA. Prevention of Catheter-Associated Urinary Tract Infections. In: 36 Abrutytn E, Goldmann DA, Scheckler WE (eds). Saunders Infection Control Reference Service. 37 Philadelphia: W.B. Saunders Co.; 1998: 169-174. 38

6 Stamm WE. Urinary Tract Infections. In: Bennett JV, Brachman PS (eds.). Hospital Infection 4th ed. 39 Philadelphia: Lippincott-Raven; 1998; 477-485. 40

7 Kass EH, Schneiderman LJ. Entry of bacteria into the urinary tract of patients with inlying catheters. 41 N Engl J Med 1957; 256: 556-7. 42

69

8 Desautels RF, Walter CW, Graves RC, Harrison JH. Technical advances in the prevention of 1 urinary tract infection. J Urol 1962; 87: 487-90. 2

9 Kunin CM, McCormack RC. Prevention of catheter-induced urinary tract infections by sterile closed 3 drainage. N Engl J Med 1966; 274: 1155-62. 4

10 Kunin CM. Urinary Tract Infections: Detection, Prevention, and Management 5th Ed. Baltimore MD: 5 Williams and Wilkins; 1997; 249-250. 6

11 Garibaldi RA, Burke JP, Dickman ML, Smith CB. Factors predisposing to bacteriuria during 7 indwelling urethral catheterisation. N Engl J Med 1974; 291: 215-8. 8

12 Saint S, Lipsky BA. Preventing Catheter-Related Bacteriuria: Should We? Can We? How? Arch 9 Intern Med 1999; 159(8): 800-808. 10

13 Gould, C.V., Umscheid, C.A., Agarwal, R.K., Kuntz, G., Pegues, D.A. & Healthcare Infection Control 11 Practices Advisory Committee (2010) Guideline for Prevention of Catheter-Associated Urinary Tract 12 Infections 2009. Infect Control Hosp Epidemiol; 31(4): 319-326. 13

14 Wong, E.S. Guideline for prevention of catheter-associated urinary tract infections. Am J Infect 14 Control, 1983; 11(1): 28-33. 15

16 3.6 Catheter maintenance 17 18 How should the drainage system be managed? 19 Maintaining a sterile, continuously closed urinary drainage system is central to the 20 prevention of CAUTI.1-6 The risk of infection reduces from 97 percent with an open 21 system to 8-15 percent when a sterile closed system is employed.7-9 Breaches in the 22 closed system such as unnecessary emptying, or changing of the urinary drainage 23 bag, or taking a urine sample, will increase the risk of CAUTI and therefore should be 24 avoided. 4,9,10 Hands must be decontaminated and clean, non-sterile gloves worn 25 before manipulation of the catheter or the closed system including drainage taps. A 26 SR has suggested that sealed (e.g., taped, pre-sealed) drainage systems contribute 27 to preventing bacteriuria.11 However, there is limited evidence as to how often 28 catheter bags should be changed. One study showed higher rates of symptomatic 29 and asymptomatic CAUTI were associated with a three day urinary drainage bag 30 change regimen when compared to no routine change regimen.14 Best practice 31 suggests that changing drainage bags only when necessary, i.e. according either to 32

ed.4,6 Reflux of urine 33 is associated with infection and consequently, drainage bags should be positioned in 34 a way that ensures the free flow of urine and prevents back-flow.4,5 It is also 35 recommended that urinary drainage bags should be hung on an appropriate stand 36 that prevents contact with the floor.9 37    38 A number of studies have investigated the addition of disinfectants and antimicrobials 39 to drainage bags as a way of preventing CAUTI.15 Three acceptable studies 16-18 from 40 our original SR19 demonstrated no reduction in the incidence of bacteriuria following 41 the addition of hydrogen peroxide or chlorhexidine to urinary drainage bags. These 42 findings are supported by a SR which suggests that adding bacterial solutions to 43 drainage bags has no effect on catheter associated infection.11 44 45 Neither we nor HICPAC guideline developers identified any additional evidence of 46 acceptable quality whilst updating our systematic reviews. 47 48 49 UC10 Connect an indwelling urethral catheter to a sterile

closed urinary drainage system. [Revised wording]

Class A

UC11 Do not break the connection between the catheter and

the urinary drainage system unless clinically indicated. Class A

70

[Revised wording]

UC12 Change urinary catheters and drainage bags when

clinically indicated and in line with the manufacturer recommendations. [New recommendation]

ClassD/ GPP

UC13 Decontaminate hands and wear a new pair of clean, non-catheter. Decontaminate hands immediately following the removal gloves. [Revised wording]

Class D/ GPP

UC14 If a urine sample is required use the sampling port and

an aseptic technique to obtain a catheter sample of urine. [Revised wording]

Class D/ GPP

UC15 Position the urinary drainage bag below the level of the

bladder on a stand that prevents contact with the floor. [Revised wording]

Class D/ GPP

UC16 Position the urinary drainage bag below the level of the

bladder on a stand that prevents contact with the floor. [Revised wording]

Class D/ GPP

UC17 Do not allow the urinary drainage bag to fill beyond

three-quarters full. Use a separate, clean container for each patient and avoid contact between the urinary drainage tap and the container. [Revised recommendation]

Class D/ GPP

UC18 Do not add antiseptic or antimicrobial solutions into

urinary drainage bags. [No change]

Class A

1 2 References 3 1 Thornton GF, Andriole VT. Bacteriuria during indwelling catheter drainage: II. Effect of a closed 4

sterile draining system. JAMA 1970; 214: 339. 5 2 Kunin CM, McCormack RC. Prevention of catheter-induced urinary-tract infections by sterile closed 6

drainage. N Engl J Med 1966; 274: 1155-1161. 7 3 Gilliespie WA, Simpson RA, Jones JE, Nashef L, Teasdale C, Speller DC. Does the addition of 8

disinfect to urine drainage bags prevent infection in catheterised patients? Lancet 1983; 1: 1037-9 1039. 10

4 Ward V, Wilson J, Taylor L, Cookson B, Glynn A. Preventing Hospital-Acquired Infection: Clinical 11 Guidelines. London: Public Health Laboratory Service 1997. p 25-29. 12

5 Dieckhaus KD, Garibaldi RA. Prevention of Catheter-Associated Urinary Tract Infections. In: 13 Abrutytn E, Goldmann DA, Scheckler WE (eds). Saunders Infection Control Reference Service. 14 Philadelphia: W.B. Saunders Co.; 1998. p. 169-174. 15

6 Wong ES, Hooton TM. Guideline for prevention of catheter-associated urinary tract infections. Am J 16 Infect Control 1983; 11(1): 28-36. 17

7 Gillespie WA, Lennon GG, Linton KB, Slade N. Prevention of urinary infections in gynaecology. 18 BMJ 1964; 2: 423-425. 19

71

8 Garibaldi RA, Burke JP, Dickman ML, Smith CB. Factors predisposing to bacteriuria during 1 indwelling urethral catheterisation. N Engl J Med 1974; 291: 215-8. 2

9 Kunin CM. Urinary Tract Infections: Detection, Prevention, and Management, 5th ed. Baltimore: 3 Williams and Wilkins; 1997. p.419. 4

10 Platt R, Murdock B, Polk BF, Rosner B. Reduction of mortality associated with nosocomial urinary 5 tract infection. Lancet 1983; 1: 893-897. 6

11 Dunn S, Pretty L, Reid H, Evans D. Management of short term indwelling urethral catheters to 7 prevent urinary tract infections. A Systematic Review. Australia: The Joanna Briggs Institute for 8 Evidence Based Nursing and Midwifery. 2000. p.64. 9

12 Gould, C.V., Umscheid, C.A., Agarwal, R.K., Kuntz, G., Pegues, D.A. & Healthcare Infection Control 10 Practices Advisory Committee Guideline for Prevention of Catheter-Associated Urinary Tract 11 Infections 2009. Infect Control Hosp Epidemiol 2010; 31(4): 319-326 12

13 NICE. Infection: Prevention and control of healthcare-associated infections in primary and 13 community care. Clinical guideline. National Institute for Health and Clinical Excellence. 2012 14 Available at: http://www.nice.org.uk (Accessed 7 June 2013) 15

14 Keerasuntonpong A, Thearawiboon W, Panthawanan A., Judaeng T, Kachintorn K, Jintanotaitavorn 16 D, Suddhisanont L, Waitayapiches S, Tiangrim S, and Thamlikitkul V. Incidence of urinary tract 17 infections in patients with short-term indwelling urethral catheters: a comparison between a 3-day 18 urinary drainage bag change and no change regimens. Am J Infect Control 2003; 31(1): 9-12. 19

15 Saint S, Lipsky BA. Preventing catheter- related bacteriuria. Should we? Can we? How? Arch 20 Intern Med 1999; 159: 800-808 21

16 Maizels M, Shaeffer AJ. Decreased incidence of bacteriuria associated with periodic instillations of 22 hydrogen peroxide into the urethral catheter drainage bag. J Urol 1980; 123: 841-845. 23

17 Sweet DE, Goodpasture HC, Holl K, Smart S, Alexander H, Hedari A. Evaluation of H2O2 24 prophylaxis of bacteriuria inpatients with long-term indwelling Foley catheters: a randomised 25 controlled study. Infect Control 1985; 6: 263-266. 26

18 Thompson RL, Haley CE, Searcy MA, Guenthner SM, Kaiser DL. Catheter-associated bacteriuria. 27 Failure to reduce attack rates using periodic instillations of a disinfectant into urinary drainage 28 systems. JAMA 1984; 251: 747-751. 29

19 Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 30 team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 31 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 32 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 33 Hospital-acquired Infections. J Hosp Infect 2001;47(Supplement):S1-S-82. Available at: 34 http://www.richardwellsresearch.com (Accessed 7 June 2013) 35

36 37 Routine meatal cleansing with antiseptic solutions is unnecessary 38 Our previous SRs1,2 found eight acceptable studies that compared meatal cleansing 39 with a variety of antiseptic/antimicrobial agents or soap and water. No reduction was 40 demonstrated in bacteriuria when using any of these preparations for meatal/peri-41 urethral hygiene compared with routine bathing or showering.3-12 42 43 Expert opinion and other SR support the view that active meatal cleansing is not 44 necessary and may increase the risk of infection.13-18 Daily routine bathing or 45 showering is all that is needed in order to maintain patient comfort. 46 47 Neither we, nor HICPAC guideline developers, identified any additional evidence of 48 acceptable quality whilst updating our systematic reviews. 49 50 51

UC19 Routine daily personal hygiene is all that is required for meatal cleansing. [Revised wording]

Class A

52

72

References 1 1 Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 2

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 3 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 4 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 5 Hospital-acquired Infections. J Hosp Infect 2001;47(Supplement):S1-S-82. Available at: 6 http://www.richardwellsresearch.com (Accessed 7 June 2013). 7

2 Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox 8 MH. epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated 9 Infections in NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 10

3 Cleland V, Cox F, Berggren H, MacInnis MR. Prevention of bacteriuria in female patients with 11 indwelling catheters. Nurs Res 1971; 20: 309-318. 12

4 Burke JP, Garibaldi RA, Britt MR. Prevention of catheter-associated urinary tract infections. 13 Efficacy of daily meatal care regimens. Am J Med 1981; 70: 655-658. 14

5 Burke JP, Jacobson JA, Garibaldi RA, Conti MT, Alling DW. Evaluation of daily meatal care 15 with poly-antibiotic ointment in the prevention of urinary catheter-associated bacteriuria. J Urol 16 1983; 129; 331-334. 17

6 Classen DC, Larsen RA, Burke JP, Stevens LE. Prevention of catheter-associated bacteriuria: 18 clinical trial of methods to block three known pathways of infection. Am J Infect Control 1991; 19 19: 136-142. 20

7 Classen DC, Larsen RA, Burke JP, Alling DW, Stevens LE. Daily meatal care for the 21 prevention of catheter-associated bacteriuria: results using frequent applications of poly-22 antibiotic cream. Infect Control Hosp Epidemiol 1991; 12: 157-162. 23

8 Huth TS, Burke JP, Larsen RA, Classen DC, Stevens LE. Randomized trial of meatal care with 24 silver sulfadiazine cream for the prevention of catheter-associated bacteriuria. J Infect Dis 25 1992; 165: 14-18. 26

9 Pellowe CM, Pratt RJ, Harper P, Loveday HP, Robinson N, Jones S, MacRae ED, and the 27 Guideline Development Group: Mulhall A, Smith G, Bray J, Carroll A, Chieveley Williams S, 28 Colpman D, Cooper L, McInnes E, McQuarrie I, Newey JA, Peters J, Pratelli N, Richardson G, 29 Shah PJR, Silk D, Wheatley C. Infection Control: Prevention of healthcare-associated infection 30 in primary and community care. Simultaneously published in: J Hosp Infect December 2003; 55 31 (Supplement 2):1-127 and Br J Infect Control December 2003 (Supplement): 4(6):1-100. 32 Available at: http://www.richardwellsresearch.com (Accessed on 7 June 2013). 33

10 Pellowe CM, Pratt RJ, Loveday HP, Harper P, Robinson N, Jones SRLJ. The epic project. 34 Updating the evidence-base for national evidence-based guidelines for preventing healthcare-35 associated infections in NHS hospitals in England: a report with recommendations. Br J Infect 36 Control 2004; 5(6): 10-15. Available at: http://www.richardwellsresearch.com (Accessed 7 June 37 2013). 38

11 Dunn S, Pretty L, Reid H, Evans D. Management of short term indwelling urethral catheters to 39 prevent urinary tract infections. A Systematic Review. Australia: The Joanna Briggs Institute for 40 Evidence Based Nursing and Midwifery. 2000. p.64. 41

12 Webster J, Hood RH, Burridge CA, Doidge ML, Phillips KM, George N. Water or antiseptic for 42 periurethral cleaning before urinary catheterization: A randomized controlled trial. Am J Infect 43 Control 2001; 29(6): 389-394. 44

13 Dieckhaus KD, Garibaldi RA. Prevention of Catheter-Associated Urinary Tract Infections. In: 45 Abrutytn E, Goldmann DA, Scheckler WE (eds). Saunders Infection Control Reference Service. 46 Philadelphia: W.B. Saunders Co.; 1998. p. 171. 47

14 Wong ES, Hooton TM. Guideline for prevention of catheter-associated urinary tract infections. 48 Am J Infect Control 1983; 11(1): 28-36. 49

15 Kunin CM. Urinary Tract Infections: Detection, Prevention, and Management, 5th ed. Baltimore: 50 Williams and Wilkins; 1997. p 249-250. 51

16 Saint S, Lipsky BA. Preventing catheter- related bacteriuria. Should we? Can we? How? Arch 52 Intern Med 1999; 159: 800-808. 53

17 NICE. Infection: Prevention and control of healthcare-associated infections in primary and 54 community care. Clinical guideline. National Institute for Health and Clinical Excellence. 2012 55 Available at: http://www.nice.org.uk (Accessed 7 June 2013). 56

73

18 Gould, C.V., Umscheid, C.A., Agarwal, R.K., Kuntz, G., Pegues, D.A. & Healthcare Infection 1 Control Practices Advisory Committee Guideline for Prevention of Catheter-Associated Urinary 2 Tract Infections 2009. Infect Control Hosp Epidemiol 2010; 31(4): 319-326. 3

4 Irrigation, instillation and washout do not prevent infection 5 Our previous SR evidence did not demonstrate any beneficial effect of bladder 6 irrigation, instillation or washout with a variety of antiseptic or antimicrobial agents in 7 preventing catheter-associated infection.1-13 8 9 Evidence from best practice supports the findings in respect of bladder irrigation, 10 instillation and washout and indicates that the introduction of such agents may have 11 local toxic effects and contribute to the development of resistant microorganisms. 12 However, continuous or intermittent bladder irrigation may be required for other 13 urological or catheter management indications.14-18 14 15 16 UC20 Do not use bladder irrigation, instillation and washout to

prevent catheter-associated infection. [Revised wording]

Class A

17 References 18 1 Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 19

team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, 20 Taylor L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based 21 Guidelines for Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing 22 Hospital-acquired Infections. J Hosp Infect 2001;47(Supplement):S1-S-82. Available at: 23 http://www.richardwellsresearch.com (Accessed 7 June 2013). 24

2 Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 25 epic2 National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in 26 NHS Hospitals. J Hosp Infect 2007 January; 65(1): supplement 1. 27

3 Davies AJ, Desai HN, Turton S, Dyas A. Does instillation of chlorhexidine into the bladder of 28 catheterised geriatric patients help reduce bacteriuria? J Hosp Infect 1987; 9: 72-75. 29

4 Ball AJ, Carr TW, Gillespie WA, Kelly M, Simpson RA, Smith PJ. Bladder irrigation with 30 chlorhexidine for the prevention of urinary infection after transurethral operations: a prospective 31 controlled study. J Urol 1987; 138: 491-494. 32

5 Jones MA, Hasan A. Controlled trial of intravesical noxythiolin in the prevention of infection 33 following outflow tract surgery. Br J Urol 1988; 62: 311-314. 34

6 Schneeberger PM, Vreede RW, Bogdanowicz JF, van Dijk WC. A randomised study on the effect of 35 bladder irrigation with povidone-iodine before removal of an indwelling catheter. J Hosp Infect 1992; 36 21: 223-229. 37

7 Warren JW, Platt R, Thomas RJ, Rosner B, Kass EH. Antibiotic irrigation and catheter-associated 38 urinary-tract infections. N Engl J Med 1978; 299: 570-573. 39

8 Muncie HLJ, Hoopes JM, Damron DJ, Tenney JH, Warren JW. Once-daily irrigation of long-term 40 urethral catheters with normal saline. Lack of benefit. Arch Intern Med 1989; 149(2): 441-443. 41

9 Kennedy AP, Brocklehurst JC, Robinson JM, Faragher EB. Assessment of the use of bladder 42 washouts/instillations in patients with long-term indwelling catheters. Brit J Urol 1992; 70(6): 610-43 615. 44

10 Cox F, Smith RF, Elliott JP, Quinn EL. Neomycin-polymyxin prophylaxis of urinary-tract infection 45 associated with indwelling catheters. Antimicrob Agents Chemother 1966; 6:165-168. 46

11 Getliffe KA. The Use of Bladder Wash-Outs to Reduce Urinary Catheter Encrustation. Br J Urol 47 1994; 73: 696-700. 48

12 Kennedy AP, Brocklehurst JC. Assessment of the Use of Bladder Washouts/Instillations in Patients 49 with Long-term Indwelling Catheters. Br J Urol 1992; 70, 610-615. 50

13 Saint S, Lipsky BA. Preventing Catheter-Related Bacteriuria: Should We? Can We? How? Arch 51 Intern Med 1999; 159(8): 800-808. 52

14 Wong ES, Hooton TM. Guideline for prevention of catheter-associated urinary tract infections. Am J 53 Infect Control 1983; 11(1): 28-36. 54

74

15 Saint S, Lipsky BA. Preventing catheter- related bacteriuria. Should we? Can we? How? Arch 1 Intern Med 1999; 59: 800-808. 2

16 Dieckhaus KD, Garibaldi RA. Prevention of Catheter-Associated Urinary Tract Infections. In: 3 Abrutytn E, Goldmann DA, Scheckler WE (eds). Saunders Infection Control Reference Service. 4 Philadelphia: W.B. Saunders Co.; 1998; 169-174. 5

17 Ward V, Wilson J, Taylor L, Cookson B, Glynn A. Preventing Hospital-Acquired Infection: Clinical 6 Guidelines. London: Public Health Laboratory Service 1997; 25-29. 7

18 Kunin CM. Urinary Tract Infections: Detection, Prevention, and Management, 5th ed. Baltimore: 8 Williams and Wilkins; 1997; 251-253. 9

 10 3.7 Education of patients, relatives and healthcare workers 11 12 Given the frequency of urinary catheterisation in hospital patients and the associated 13 risk of UTI, it is important that patients, their relatives and healthcare workers 14 responsible for catheter insertion and management are educated about infection 15 prevention. All those involved must be aware of the signs and symptoms of UTI and 16 how to access expert help when difficulties arise. Healthcare professionals must be 17 confident and proficient in associated procedures. 18 19 We identified two SR that reported the eviden20 education on reducing the risk of CAUTI within other system interventions.1,2 Most of 21 the studies included in these reviews provided low grade evidence from uncontrolled 22 before after studies where a combination of different system interventions focusing 23 on reducing the use of urethral catheters and risk of CAUTI were introduced. The 24 first SR1 identified one small CBA study3 of an educational intervention with guideline 25 change and posters that was associated with a reduction in use of urethral catheters 26 (RR 0.86; 95%CI 0.68-1.10). Another SR included one CBA study that demonstrated 27 a significant (p<0.01) increase in adherence to a clinical guideline on the insertion 28 and maintenance of urethral catheters in association with an education 29 programme.2,4 Another study reported a reduction in CAUTI and increase in 30 adherence to protocols for hand hygiene and catheter care in association with an 31 education programme; however this study did not include a control group.5 32 33 34 UC21 Healthcare workers should be trained and updated in

the appropriate use, selection, insertion, maintenance and removal of urinary catheters. [Revised wording]

Class D/ GPP

UC22 Ensure patients, relatives and carers are given

information regarding: reasons for catheter insertion; participating in the management of the catheter; minimising the risk of urinary tract infection and support and review from healthcare professionals if discharged with a catheter. [Revised recommmendation]

Class D/ GPP

References 35 1. Murphy, C., Fader, M. & Prieto, J. Interventions to minimise the initial use of indwelling urinary 36

catheters in acute care: A systematic review. Int J Nurs Stud, 2013: (in press). 37 2. Shojania KG, McDonald KM, Wachter RM, et al., (2004) Closing the Quality Gap: A Critical 38

Analysis of Quality Improvement Strategies (Vol. 1: Series Overview and Methodology). 39 Rockville (MD: Agency for Healthcare Research and Quality (US); 2004 Aug. (Technical 40 Reviews, No. 9.1.) Available from: http://www.ncbi.nlm.nih.gov/books/NBK43908/ (Accessed 7 41 June 2013). 42

75

3. Stéphan F, Sax H, Wachsmuth M. Hoffmeyer P, Clergue F, Pittet, D. Reduction of Urinary 1 Tract Infection and Antibiotic Use after Surgery: A Controlled, Prospective, Before-After 2 Intervention Study. Clinical Infect Dis 2006; 42(11): 1544-1551. 3

4. Ching, T.Y. & Seto, W.H. Evaluating the efficacy of the infection control liaison nurse in the 4 hospital. J Adv Nurs 1990; 15(10): 1128-1131. 5

5. Rosenthal, V.D., Guzman, S. & Safdar, N. Effect of Education and Performance Feedback on 6 Rates of Catheter-Associated Urinary Tract Infection in Intensive Care Units in Argentina. Infect 7 Control Hosp Epidemiol 2004; 25(1): 47-50. 8

9 3.8 System interventions for reducing the risk of infection 10 11 There have been a number of studies that report the effect of quality improvement 12 programmes on the risk of CAUTI.1 The components of these programmes include 13 various combinations of clinical guidelines for catheter insertion and maintenance, 14 education, audit and feedback of compliance with policy, physician/nurse reminder 15 systems (to prompt removal if no longer necessary), automated or nurse-driven 16 removal protocols (where the catheter is removed after a specified period e.g. 48-17 72hr, unless countermanded by the physician) and the use of bladder scanners to 18 assess urinary retention and support appropriate catheterisation.1. 19 20 We identified three SR relevant to this question.2-4 The first was a review of 21 interventions to remind physician/nurse to remove unnecessary catheters and the 22 outcome on CAUTI, urinary catheter use and catheter replacement and included 14 23 studies (one RCT, one NRCT, three CBA and nine uncontrolled before after 24 studies).2 Interventions included prewritten or computer generated stop order, nurse 25 generated daily bedside reminders to remove catheters and daily use of a checklist 26 or protocol to review need for the catheter. Some studies also implemented catheter 27 placement restrictions and education. The meta-analysis suggested that the use of 28 reminder or stop order systems reduced the rate of CAUTI was by 52% (p<0.001) 29 and the mean duration of catheterisation by 37%, with 2.61 fewer days of 30 catherisation in the intervention versus control groups, and no difference in re-31 catherisation rates. 32 33 The second SR was a review of interventions to minimise the placement of urethral 34 catheters in patients in acute care.3 It included one RCT, one NRCT and six 35 uncontrolled before after studies. Interventions included various combinations of 36 clinician reminders, stop orders and indication checklist, use of bladder scanners and 37 education. Authors concluded that the studies were too small and heterogeneous to 38 draw a definitive conclusion about the efficacy in terms of reducing inappropriate 39 catheter placement. 40 41 The third SR included three CBA and seven uncontrolled before after studies 42 measuring interventions that increased adherence to catheter care protocols or 43 reduced unnecessary catheter use.4 Interventions included reminders, stop orders, 44 use of bladder scanners, education and catheterisation protocols with audit and 45 feedback on performance. Physician/nurse reminders, in particular automatic stop 46 orders, were found to reduce the duration of catheterisation although there was 47 insufficient data to determine their effect on CAUTI. 48 49 Many studies in this area are uncontrolled before after designs and therefore 50 susceptible to bias in favour of the intervention. However these interventions 51 constitute best practice and this evidence supports the use of systems to minimise 52 the insertion of catheters and promote timely removal to reduce both the duration of 53 catheterisation and the risk of CAUTI. 54

76

1 2 UC23 Use quality improvement systems to support the

appropriate use and management of short-term urethral catheters and ensure their timely removal. These may include:

Protocols for catheter insertion Use of the bladder ultrasound scanners to

assess and manage urinary retention Reminders to view the continuing use or prompt

the removal of catheters Audit and feedback of compliance with practice

guidelines Continuing professional education.

[New recommendation]

Class D/ GPP

UC24 No patient should be discharged or transferred with an

indwelling urethral catheter without a plan documenting the:

Clinical indication(s) for continuing catheterisation

Type of catheter inserted Date of insertion Planned date for removal or a date for review by

an appropriate clinician e.g., urologist, continence adviser.

[New recommendation]

Class D/ GPP

References 3

1 Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA and Healthcare Infection Control 4 Practices Advisory Committee Guideline for Prevention of Catheter-Associated Urinary Tract 5 Infections 2009. Infect Control Hosp Epidemiol, 2010; 31(4): 319-326. 6

2 Meddings J, Rogers MAM, Macy M, Saint S. Systematic Review and Meta-Analysis: Reminder 7 Systems to Reduce Catheter-Associated Urinary Tract Infections and Urinary Catheter Use in 8 Hospitalized Patients. Clin Infect Dis 2010; 51(5): 550-560. 9

3 Murphy, C., Fader, M. & Prieto, J. Interventions to minimise the initial use of indwelling urinary 10 catheters in acute care: A systematic review. Int J Nurs Stud 2013: (in press). 11

4 Shojania KG, McDonald KM, Wachter RM, et al., (2004) Closing the Quality Gap: A Critical 12 Analysis of Quality Improvement Strategies (Vol. 1: Series Overview and Methodology). 13 Rockville (MD: Agency for Healthcare Research and Quality (US); 2004 Aug. (Technical 14 Reviews, No. 9.1.) Available from: http://www.ncbi.nlm.nih.gov/books/NBK43908/. (Accessed 7 15 June 2013). 16

17

77

SECTION 4 1

GUIDELINES FOR PREVENTING INFECTIONS ASSOCIATED 2 WITH THE USE OF INTRAVASCULAR ACCESS DEVICES 3 (IVAD) 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45

78

Section 4 - Guidelines for preventing infections associated 1 with the use of Intravascular Access Devices (IVAD) 2 3

4.1 Introduction 4 5 This guidance is based on the best critically appraised evidence currently available. 6 The type and class of supporting evidence explicitly linked to each recommendation 7 is described. All recommendations are endorsed equally and none are regarded as 8 optional. These recommendations are not detailed procedural protocols and need to 9 be incorporated into local guidelines. 10 11 Background and context to the Guidelines 12 Intravascular access devices, including peripheral, central venous and arterial 13 catheters, are commonly used in the management of patients in acute care settings. 14 Central venous catheters (CVC) are frequently used during clinical care and include 15 peripherally inserted, non-tunneled and tunnelled, and totally implantable CVC (Table 16 1).1 The use of any of these catheters can result in bloodstream infection. 17 18 Catheter-related bloodstream infections (CR-BSI) associated with the insertion and 19 maintenance of CVC are potentially among the most dangerous complications 20 associated with healthcare.2-4 The Health Protection Agency reports that 0.5% 21 prevalence accounts for 6.8% of HCAI.2 Sixty-four per cent of CR-SBI occur in 22 patients with a device, with previous point prevalence data reporting that 0.85% 23 prevalence accounts for 7% of HCAI and, of these, 70% are primary CR-BSI.3 24 Although the prolonged use of peripheral venous catheters (PVC) may cause 25 phlebitis, they are rarely associated with CR-BSI.1 26 27 Catheter-related bloodstream infection involves the presence of systemic infection 28 and evidence implicating the intravascular catheter as its source, i.e. the isolation of 29 the same microorganism from blood cultures as that shown to be significantly 30 colonising the intravascular catheter with clinical features of bacteraemia. Catheter 31 colonisation, also referred to as central line-associated bloodstream infection 32 (CLABSI), refers to a significant growth of microorganisms on either the endoluminal 33 or the external catheter surface beneath the skin in the absence of systemic 34 infection.1,4 35 36 The microorganisms that colonise catheter hubs and the skin adjacent to the 37 insertion site are the source of most CR-BSI. Coagulase-negative staphylococci, 38 particularly Staphylococcus epidermidis, are the most frequently implicated 39 microorganisms associated with CR-BSI. Other microorganisms commonly involved 40 include Staphylococcus aureus, Candida species and enterococci.5-7 41 42 Catheter-related bloodstream infection is generally caused either by skin 43 microorganisms at the insertion site, which contaminate the catheter during insertion 44 and migrate along the cutaneous catheter track,8-10 or microorganisms from the 45 hands of healthcare workers that contaminate and colonise the catheter hub during 46 care interventions.11 Less commonly, infusate contamination or bloodstream seeding 47 from a different site of infection in the body is implicated as a cause of CR-BSI.12,13 48 49 50 51 52 53

79

Table 1. Catheters used for venous and arterial access 1 (Adopted from 2011) 1 2 3 Catheter type

Entry Site

Length

Comments

Peripheral venous catheters

Usually inserted in veins of forearm or hand

<3 inches Phlebitis with prolonged use; rarely associated with bloodstream infection

Peripheral arterial catheters

Usually inserted in radial artery; can be placed in femoral, axillary, brachial, posterior tibial arteries

<3 inches Low infection risk; rarely associated with bloodstream infection

Midline catheters

Inserted via the antecubital fossa into the proximal basilic or cephalic veins; does not enter central veins, peripheral catheters

3 to 8 inches

Anaphylactoid reactions have been reported with catheters made of elastomeric hydrogel; lower rates of phlebitis than short peripheral catheters

Nontunneled central venous catheters

Percutaneously inserted into central veins (subclavian, internal jugular, or femoral)

depending on patient size

Account for majority of CRBSI

Pulmonary artery catheters

Inserted through a Teflon® introducer in a central vein (subclavian, internal jugular, or femoral)

depending on patient size

Usually heparin bonded; similar rates of bloodstream infection as CVCs; subclavian site preferred to reduce infection risk

Peripherally inserted central venous catheters (PICC)

Inserted into basilic, cephalic, or brachial veins and enter the superior vena cava

depending on patient size

Lower rate of infection than nontunneled CVCs

Tunneled central venous catheters

Implanted into subclavian, internal jugular, or femoral veins

depending on patient size

Cuff inhibits migration of organisms into catheter tract; lower rate of infection than nontunneled CVC

Totally implantable

Tunneled beneath skin and have subcutaneous port accessed with a needle; implanted in subclavian or internal jugular vein

depending on patient size

Lowest risk for CRBSI; improved patient self-image; no need for local catheter-site care; surgery required for catheter removal

Umbilical catheters

Inserted into either umbilical vein or umbilical artery depending

on patient size

Risk for CRBSI similar with catheters placed in umbilical vein versus artery

4 5 6 References 7 1 8

Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 9

80

Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-1 Related Infections. Clin Infect Dis 2011 May; 52(9): e162-93. doi: 10.1093/cid/cir257. 2

2 Health Protection Agency. English National Point Prevalence Survey on Healthcare associated 3 Infections and Antimicrobial Use, 2011. Preliminary data. HPA 2012. London. p.140. 4

3 Smyth ETM, McIlvenny G, Enstone J, Emmerson AM, Humphreys H, Fitzpatrick F, Davies E, 5 Newcombe RG, Spencer RC. Four Country Healthcare Associated Infection Prevalence Survey 6 2006: overview of the results. J Hosp Infect 2008; 69: 230-248. 7

4 Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients: excess 8 length of stay, extra costs, and attributable mortality. JAMA 1994; 271: 1598-1601. 9

5 Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial 10 bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide 11 surveillance study. Clin Infect Dis 2004; 39: 309 17. 12

6 Gaynes R, Edwards JR. Overview of nosocomial infections caused by gram-negative bacilli. Clin 13 Infect Dis 2005; 41: 848 54. 14

7 Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed 15 short-term central venous catheters. Int Care Med 2004; 30: 62 7. 16

8 Maki DG, Weise CE, Sarafin HW. A semiquantitative culture method for identifying intravenous-17 catheter-related infection. N Engl J Med 1977; 296: 1305 9. 18

9 Mermel LA, McCormick RD, Springman SR, Maki DG. The pathogenesis and epidemiology of 19 catheter-related infection with pulmonary artery Swan-Ganz catheters: a prospective study utilizing 20 molecular subtyping. Am J Med 1991; 91: 197S 205. 21

10 Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of 22 indwelling vascular catheters: a quantitative relationship between luminal colonization and duration 23 of placement. J Infect Dis 1993; 168: 400 7. 24

11 Dobbins BM, Kite P, Kindon A, McMahon MJ, Wilcox MH. DNA fingerprinting analysis of coagulase 25 negative staphylococci implicated in catheter related bloodstream infections. J Clin Pathol 2002; 26 55: 824 8. 27

12 Anaissie E, Samonis G, Kontoyiannis D, et al. Role of catheter colonization and infrequent 28 hematogenous seeding in catheter-related infections. Eur J Clin Microbiol Infect Dis 1995; 14: 13429 7. 30

13 Raad I, Hanna HA, Awad A, et al. Optimal frequency of changing intravenous administration sets: is 31 it safe to prolong use beyond 72 hours? Infect Control Hosp Epidemiol 2001; 22: 136 9. 32

33 34 4.2 What is the evidence for these guidelines? 35 36 37 These guidelines are primarily based upon an expert review of evidence-based 38 guidelines for preventing intravascular device-related infections, developed at the 39 Centers for Disease Control and Prevention (CDC) in the United States of America 40 by the Healthcare Infection Control Practices Advisory Committee (HICPAC), 41 published in 2011.1 42 43 The AGREE II collaboration appraisal instrument was used by four appraisers to 44 independently review the updated guidelines.2 The appraisal process resulted in the 45 decision that the development processes were valid and that the guidelines were 46 evidence-based, categorised to the strength of the evidence examined, reflective of 47 current concepts of best practice, and acknowledged as the most authoritative 48 reference guidelines currently available. They were subsequently used as the 49 principal source of evidence for updating the epic2 guidelines.3 50 51 52 Following our expert review, we systematically searched, retrieved and appraised 53 additional evidence published since the 2011 HICPAC guidelines were developed. 54 Our Search period for additional evidence spanned from 2009 to 2012. The 55 recommendations are divided into nine distinct interventions: 56 57 58

1. Education of healthcare workers and patients; 59 2. General asepsis; 60 3. Selection of catheter type; 61

81

4. Selection of catheter insertion site; 1 5. Maximal sterile barrier precautions during catheter insertion; 2 6. Cutaneous antisepsis; 3 7. Catheter and catheter site care; 4 8. Catheter replacement strategies; 5 9. General principles for catheter management. 6

7 These guidelines apply to caring for all adults and children over the age of one year 8 in National Health Service (NHS) acute care settings with a central or peripheral 9 intravascular catheter that is being used for the administration of fluids, medications, 10 blood components and/or total parenteral nutrition (TPN). They should be used in 11 conjunction with the recommendations on Standard Principles for Preventing HCAI, 12 previously described in these guidelines. 13 14 Although these recommendations describe general principles of best practice that 15 apply to all patients in hospital in whom an intravascular catheter is being used, they 16 do not specifically address the more technical aspects of the care of infants under the 17 age of one year, or those children or adults receiving haemodialysis, who will 18 generally have their intravascular catheters managed in dialysis centres. 19 20 21 References 22 1. 23

Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 24 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-25 Related Infections, Clin Infect Dis. 2011 May; 52(9): e162-93. doi: 10.1093/cid/cir257. Available at: 26 http://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf (Accessed 4 June 2013). 27

2. Agree Trust. Appraisal of Guidelines for Research and Evaluation (AGREE) II. Available at: 28 http://www.agreetrust.org/ (Accessed 3 June 2013). 29

3. Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SRLJ, McDougall C, Wilcox MH. 30 epic2: National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS 31 Hospitals in England, J Hosp Infect 2007; 65S: S1-S64. 32

33 34 4.3 Education of Healthcare Workers and Patients 35 36 To improve patient outcomes and reduce healthcare costs, it is essential that 37 everyone involved in caring for patients with intravascular catheters is educated 38 about infection prevention. Healthcare workers in hospitals need to be confident and 39 proficient in infection prevention practices and to be aware of the signs and 40 symptoms of clinical infection. Well-organised educational programmes that enable 41 healthcare workers to provide, monitor, and evaluate care and continually increase 42 their competence are critical to the success of any strategy designed to reduce the 43 risk of infection. Evidence reviewed by HICPAC consistently demonstrated that the 44 risk of infection declines following the standardisation of aseptic care1-7 and increases 45 when the maintenance of intravascular catheters is undertaken by inexperienced 46 healthcare workers.4,8 47 48 We identified two recent systematic reviews (SR) that assessed the effectiveness of 49 education interventions in reducing CR-BSI.9,10 The first concluded that current 50 evidence comes predominantly from uncontrolled before-after studies that do not 51 convincingly distinguish intervention effectiveness from secular trends. Clinical 52 practices are being addressed by a wide variety of educational strategies that do not 53 draw upon pedagogic, theoretical or conceptual frameworks and consequently do not 54 provide generalisable conclusions about the most effective approaches to education 55 to improve practice.9 56

82

1 The second SR concluded that educational interventions appear to have the most 2 prolonged and profound effect when used in conjunction with audit and feedback, 3 and when availability of clinical equipment is consistent with the content of the 4 education provided. Second, educational interventions will have a greater impact if 5 baseline compliance to best practice is low. Third, repeated sessions, fed into daily 6 practice, using practical participation, appear to have a small, additional effect on 7 practice change, when compared to education alone.10 8 9 10 11 IVAD 1

Healthcare workers caring for patients with intravascular catheters should be trained and assessed as competent in using and consistently adhering to the infection prevention practices for the prevention of catheter-related bloodstream infection. [Revised wording]

Class D/ GPP

IVAD 2

Before discharge from hospital, patients with intravascular catheters and their carers should be taught any techniques they may need to use to prevent infection and safely manage their device. [Revised wording]

Class D/ GPP

12 13 References 14 1. Yoo S, Ha M, Choi D, Pai H. Effectiveness of surveillance of central catheter-related bloodstream 15

infection in an ICU in Korea. Infect Control Hosp Epidemiol 2001; 22: 433 6. 16 2. Coopersmith CM, Rebmann TL, Zack JE, et al. Effect of an education program on decreasing 17

catheter-related bloodstream infections in the surgical intensive care unit. Crit Care Med 2002; 30: 18 59 64. 19

3. Sherertz RJ, Ely EW, Westbrook DM, et al. Education of physiciansin-training can decrease the risk 20 for vascular catheter infection. Ann Intern Med 2000; 132: 641 8. 21

4. Eggimann P, Harbarth S, Constantin MN, Touveneau S, Chevrolet JC, Pittet D. Impact of a 22 prevention strategy targeted at vascular-access care on incidence of infections acquired in intensive 23 care. Lancet 2000; 355: 1864 8. 24

5. Sanders RA, Sheldon GF. Septic complications of total parenteral nutrition. A five year experience. 25 Am J Surg 1976; 132: 214 20. 26

6. Ryan JA Jr., Abel RM, Abbott WM, et al. Catheter complications in total parenteral nutrition. A 27 prospective study of 200 consecutive patients. N Engl J Med 1974; 290: 757 61. 28

7. Murphy LM, Lipman TO. Central venous catheter care in parenteral nutrition: a review. JPEN J 29 Parenter Enteral Nutr 1987; 11: 190 201. 30

8. Armstrong CW, Mayhall CG, Miller KB, et al. Prospective study of catheter replacement and other 31 risk factors for infection of hyperalimentation catheters. J Infect Dis 1986; 154: 808 16. 32

9. Frampton GK, Harris P, Cooper K, Cooper T, Cleland J, Jones J, et al. Educational interventions for 33 preventing vascular catheter bloodstream infections in critical care: evidence map, systematic 34 review and economic evaluation.  In press. Health Technology Assessment. Project No. 09/01/25. 35

10. Cherry, GM, Brown, JM, Neal, T & Shaw BN (2010) What features of educational interventions lead 36 to competence in aseptic insertion and maintenance of CV catheters in acute care? Medical 37 Teacher BEME Guide No.15, 32: 198-218. 38

39 40 4.4 General Asepsis 41 42 Hand antisepsis and meticulous aseptic technique are essential during catheter 43 insertion, manipulation, changing catheter site dressings and for accessing the 44 system. Hand antisepsis can be achieved by washing hands with an antimicrobial 45 liquid soap and water, or by using an alcohol-based handrub (ABHR).1 When hands 46 are visibly dirty or potentially contaminated with organic material, such as blood and 47

83

other body fluids or excretions, they must first be washed with liquid soap and water 1 if ABHR is going to be used to achieve hand antisepsis. 2 3 Appropriate aseptic technique should be used for the insertion and management of 4 intravenous catheters. Gloves should be worn for procedures involving contact with 5 blood or body fluids. These can be a new pair of non-sterile gloves, used in 6 conjunction with a non-touch technique, for insertion of a peripheral vascular catheter 7 or replacement of a soiled insertion site dressing, however, sterile gloves must be 8 worn for placement of central catheters.2  9

Standard principles for infection prevention, previously described in these guidelines, 10 give additional advice on hand decontamination, the use of gloves and other 11 protective equipment. 12 13 14 IVAD 3

Use an aseptic technique for the insertion and care of an intravascular access device and when administering intravenous drugs. [Revised wording]

Class B

IVAD 4

Hands must be decontaminated, either by washing with liquid soap and water or with an alcohol handrub, before and after any contact with the intravascular catheter or insertion site. [Revised recommendation]

Class A

IVAD 5

Hands that are visibly soiled or contaminated with dirt or organic material must be washed with liquid soap and water before using an alcohol handrub. [No change]

Class A

15 16 References 17 1. Boyce JM, Pittet D. Guideline for hand hygiene in health-care settings: recommendations of the 18

Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA 19 Hand Hygiene Task Force. Infect Control Hosp Epidemiol 2002; 23: S3 40. 20

2. O21 Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 22 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-23 Related Infections, Clin Infect Dis 2011 May; 52(9): e162-93. doi: 10.1093/cid/cir257. 24

25 26 4.5 Selection of Catheter Type 27 28 29 Different types of intravascular devices are available: 30 31

made of different materials; 32 have one or more lumens; 33 coated or impregnated with antimicrobial or antiseptic agents or heparin-34

bonded; 35 cuffed and designed to be tunnelled; 36 have totally implantable ports. 37

38 The selection of the most appropriate intravascular catheter for each individual 39 patient can reduce the risk of subsequent catheter-related infection. 40

84

1 2 Catheter material 3 Intravascular catheter material may be an important determinant in the development 4 of catheter-related infection. Polytetrafluroethylene (Teflon®) and polyurethane 5 catheters have been associated with fewer infections than catheters made of 6 polyvinyl chloride or polyethylene.1-3 7 8 Number of catheter lumens 9 Multi-lumen intravascular access devices may be used because they permit the 10 concurrent administration of various fluids and medications, hyperalimentation, and 11 haemodynamic monitoring among critically ill patients. 12 13 Several randomised controlled trials (RCT) and other studies suggest that multi-14 lumen catheters are associated with a higher risk of infection than single lumen 15 catheters.4-10 However, other studies examined by HICPAC failed to demonstrate a 16 difference in the rates of CR-BSI.11,12 17 18 HICPAC noted that multi-lumen catheter insertion sites may be particularly prone to 19 infection because of increased trauma at the insertion site or because multiple ports 20 increase the frequency of CVC manipulation.7,8 Although patients with multi-lumen 21 catheters tend to be more ill than those without such catheters, the infection risk 22 observed with these catheters may have been independent of the p23 underlying disease severity.9 24 25 Two additional studies were identified in our previous SRs.13 In a SR and quantitative 26 meta-analysis focused on determining the risk of CR-BSI and catheter colonisation in 27 multi-lumen catheters compared with single-lumen catheters, reviewers reported that, 28 although CR-BSI was more common in patients with multi-lumen catheters, when 29 confined to high quality studies that control for patient differences, there is no 30 significant difference in rates of CR-BSI for the two types of catheter.14 This analysis 31 suggests that multi-lumen catheters are not a significant risk factor for increased CR-32 BSI or local catheter colonisation compared with single-lumen CVC. 33 34 Another SR and quantitative meta-analysis tested whether single- versus multi-lumen 35 CVC had an impact on catheter colonisation and CR-BSI. Study authors concluded 36 that there is some evidence from five RCTs with data on 530 CVC, that for every 20 37 single-lumen catheters inserted, one CR-BSI (which would have occurred had multi-38 lumen catheters been used) would be avoided. As authors were only able to analyse 39 a limited number of trials, further large RCTs of adequate methodology are needed to 40 confirm these findings. In the meantime, it may be reasonable for patients who need 41 a CVC to choose a single-lumen catheter whenever there is no indication for a multi-42 lumen catheter.15 43 44 Neither we nor HICPAC guideline developers identified any additional evidence of 45 acceptable quality whilst updating our systematic reviews. 46 47 48 IVAD 6

Use a catheter with the minimum number of ports or lumens essential for the management of the patient. [Revised wording]

Class A

IVAD 7 If a multi-lumen catheter is used, designate one port exclusively for hyperalimentation to administer parenteral nutrition.

Class D/ GPP

85

[Revised wording]

References 1 1. Maki DG, Ringer M. Risk factors for infusion-related phlebitis with small peripheral venous catheters. 2

A randomized controlled trial. Ann Intern Med 1991; 114: 845 54. 3 2. Sheth NK, Franson TR, Rose HD, Buckmire FL, Cooper JA, Sohnle PG. Colonization of bacteria on 4

polyvinyl chloride and Teflon intravascular catheters in hospitalized patients. J Clin Microbiol 1983; 5 18: 1061 3. 6

3. Maki DG, Ringer M. Evaluation of dressing regimens for prevention of infection with peripheral 7 intravenous catheters. Gauze, a transparent polyurethane dressing, and an iodophor-transparent 8 dressing. JAMA 1987; 258: 2396 403. 9

4. 10 RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the Prevention of 11 Intravascular Catheter Related Infections. Clin Infect Dis 2002; 35: 1281-207. 12

5. Pemberton LB, Lyman B, Lander V, Covinsky J. Sepsis from triple- vs single-lumen catheters during 13 total parenteral nutrition in surgical or critically ill patients. Arch Surg 1986; 121: 591-594. 14

6. McCarthy MC, Shives JK, Robison RJ, Broadie TA. Prospective evaluation of single and triple lumen 15 catheters in total parenteral nutrition. JPEN 1987; 11: 259-262. 16

7. Hilton E, Haslett TM, Borenstein MT, Tucci V, Isenberg HD, Singer C. Central catheter infections; 17 single- versus triple-lumen catheters. Influence of guide wires on infection rates when used for 18 replacement of catheters. Am J Med 1988; 84: 667-672. 19

8. Yeung C, May J, Hughes R. Infection rate for single-lumen vs triple-lumen subclavian catheters. 20 Infect Control Hosp Epidemiol 1988; 9:154-159. 21

9. Clark-Christoff N, Watters VA, Sparks W, Snyder P, Grant JP. Use of triple-lumen subclavian 22 catheters for administration of total parenteral nutrition. JPEN 1992; 16: 403-407. 23

10. Early TF, Gregory RT, Wheeler JR, Snyder SO Jr., Gayle RG. Increased infection rate in double-24 lumen versus single-lumen Hickman catheters in cancer patients. South Med J 1990; 83: 34 6. 25

11. Farkas JC, Liu N, Bleriot JP, Chevret S, Goldstein FW, Carlet J. Single-versus triple-lumen central 26 catheter-related sepsis: a prospective randomised study in a critically ill population. Am J Med 1992; 27 93:2 77-282. 28

12. Gil RT, Kruse JA, Thill-Baharozian MC, Carolson RW. Triple- vs single-lumen central venous 29 catheters. A prospective study in a critically ill population. Arch Intern Med 1989; 149: 1139-1143. 30

13. Pratt RJ, Pellowe C, Loveday HP, Robinson N, Smith GW, and the epic guideline development 31 team; Barrett S, Davey P, Harper P, Loveday C, McDougall C, Mulhall A, Privett S, Smales C, Taylor 32 L, Weller B, and Wilcox M. The epic Project: Developing National Evidence-based Guidelines for 33 Preventing Healthcare associated Infections. Phase 1: Guidelines for Preventing Hospital-acquired 34 Infections. J Hosp Infect 2001; 47(Supplement): S1-S-82. 35

14. Dezfulian C, Lavelle J, Nallamothu BK, Kaufman SR, Saint, S. Rates of infection for single-lumen 36 versus multilumen central venous catheters: A meta-analysis. Crit Care Med 2003: 31(9): 2385-37 2390. 38

15. Zürcher M, Tramèr M, Walder B. Colonization and Bloodstream Infection with Single- Versus Multi-39 Lumen Central Venous Catheters: A Quantitative Systematic Review. Anesth Analg 2004; 99: 177-40 82. 41

42 43 Tunnelled and totally implantable ports 44 Surgically implanted (tunnelled) devices, e.g. Hickman catheters, are commonly 45 used to provide vascular access (and stable anchorage) to patients requiring long-46 term intravenous therapy. Alternatively, totally implantable intravascular access 47 devices, e.g. Port-A-Cath , are also tunnelled under the skin, but have a 48 subcutaneous port or reservoir with a self-sealing septum that is accessible by 49 needle puncture through intact skin. 50 51 In developing their 1996 guidelines, HICPAC examined multiple studies that 52 compared the incidence of infection associated with long-term tunnelled CVC and/or 53 totally implantable intravascular devices with that from percutaneously (non-54 tunnelled) inserted catheters.1 Although, in general, most studies reported a lower 55 rate of infection in patients with tunnelled CVC,2-10 some studies (including one RCT) 56 found no significant difference in the rate of infection between tunnelled and non-57 tunnelled catheters.11-12 Additionally, most studies examined by HICPAC concluded 58 that totally implantable devices had the lowest reported rates of CR-BSI compared to 59 either tunnelled or non-tunnelled CVC.13-23 60

86

1 Additional evidence was obtained from studies of efficacy of tunnelling to reduce 2 catheter-related infections in patients with short-term CVC. One RCT demonstrated 3 that subcutaneous tunnelling of short-term CVC inserted into the internal jugular vein 4 reduced the risk for CR-BSI.24 In a later RCT, the same investigators failed to show a 5 statistically significant difference in the risk for CR-BSI for subcutaneously tunnelled 6 femoral vein catheters.25 7 8 An additional meta-analysis of RCTs focused on the efficacy of tunnelling short-term 9 CVC to prevent catheter-related infections.26 Data synthesis demonstrated that 10 tunnelling decreased catheter colonisation by 39% and decreased CR-BSI by 44%, 11 in comparison with non-tunnelled placement. The majority of the benefit in the 12 decreased rate of catheter-sepsis came from one trial of CVC inserted at the internal 13 jugular site. The reduction in risk was not significant when pooled with data from five 14 subclavian catheter trials. Tunnelling was not associated with increased risk of 15 mechanical complications from placement or technical difficulties during placement. 16 However, these outcomes were not rigorously evaluated. This meta-analysis 17 concluded that tunnelling decreased catheter-related infections, however, a synthesis 18 of the evidence in this meta-analysis does not support routine subcutaneous 19 tunnelling of short-term subclavian venous catheters and this cannot be 20 recommended unless efficacy is evaluated at different placement sites and relative to 21 other interventions. 22 23 Neither we nor HICPAC identified any additional evidence of acceptable quality whilst 24 updating our SR. 25 26 27 IVAD 8

Use a tunnelled or implanted central venous access device with a subcutaneous port for patients in whom long-term vascular access is required e.g. oncology patients. [Revised wording]

Class A

28 29 References 30 1. Pearson ML. Hospital Infection Control Practices Advisory Committee. Guideline for Prevention of

Intravascular-device-related Infections. Infect Control Hosp Epidemiol 1996 July; 17(7): 438-473. 2. Abraham JL, Mullen JL. A prospective study of prolonged central venous access in leukaemia.

JAMA 1982; 248: 2868-2873. 3. Shapiro ED, Wald ER, Nelson KA, Spiegelman KN. Broviac catheter-related bacteraemia in

oncology patients. Am J Dis Child 1982; 136: 679-681. 4. Press OW, Ramsey PG, Larson EB, Fefer A, Hickman RO. Hickman catheter infections in

patients with malignancies. Medicine 1984; 63: 189-200. 5. Darbyshire PJ, Weightman NC, Speller DC. Problems associated with indwelling central venous

catheters. Arch Dis Child 1985; 60: 129-134. 6. Pessa ME, Howard RJ. Complications of Hickman-Broviac catheters. Surg Gynecol Obstet 1985;

161: 257-260. 7. Schuman ES, Winters V, Gross GF, Hayes JF. Management of Hickman catheter sepsis. Am J

Surg 1985; 149: 627-628. 8. Rannem T, Ladefoged K, Tvede M, Lorentzen JE, Jarnum S. Catheter-related septicemia in

patients receiving home parenteral nutrition. Scand J Gastroenterol 1986; 21: 455-460. 9. Shulman RJ, Smith EO, Rahman S, Gardner P, Reed T, Mahoney D. Single- vs double-lumen

central venous catheters in pediatric oncology patients. Am J Dis Child 1988; 142: 893-895. 10. Weightman NC, Simpson EM, Speller DC, Mott MG, Oakhill A. Bacteraemia related to indwelling

central venous catheters: prevention, diagnosis, and treatment. Euro J Clin Microbio Infect Dis 1988; 7: 125-129.

11. Raad I, Davis S, Becker M, et al. Low infection rate and long durability of nontunneled silastic catheters. A safe cost-effective alternative for long-term venous access. Arch Intern Med 1993; 153: 1791-1796.

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12. Andrivet P, Bacquer A, Ngoc CV, et al. Lack of clinical benefit from subcutaneous tunnel insertion of central venous catheters in immunocompromised patients. Clin Infect Dis 1994; 18: 199-206.

13. Gyves J, Ensminger W, Niederhuber J, et al. A totally-implanted injection port system for blood sampling and chemotherapy administration. JAMA 1984; 251: 2538-2541.

14. Lokich JJ, Bothe AJ, Benotti P, Moore C. Complications and management of implanted venous access catheters. J Clin Oncol 1985; 3: 710-717.

15. Khoury MD, Lloyd LR, Burrows J, Berg R, Yap J. A totally implanted venous access system for the delivery of chemotherapy. Cancer 1985; 56: 1231-1234.

16. McDowell HP, Hart CA, Martin J. Implantable subcutaneous venous catheters. Arch Dis Childh 1986; 61: 1037-1038.

17. Brickner H, Saeter G. Fifty-intravenous chemotherapy. Cancer 1986; 57: 1124-1129.

18. Wurzel CL, Halom K, Feldman JG, Rubin LG. Infection rates of Broviac-Hickman catheters and implantable venous devices. Am J Dis Child 1988; 142: 536-540.

19. Kappers-Klunne MC, Degener JE, Stijnen T, Abels J. Complications from long-term indwelling central venous catheters in hematologic malignancy patients with special reference to infection. Cancer 1989; 64: 1747-1752.

20. Carde P, Cosset-Delaigue MF, Laplanche A, Chareau I. Classical external indwelling central venous catheter versus total implanted venous access systems for chemotherapy administration. A randomised trial in 100 patients with solid tumors. Euro J Cancer Clin Oncol 1989; 25: 939-944.

21. Pegues D, Axelrod P, McClarren C, et al. Comparison of infections in Hickman and implanted port catheters in adult solid tumor patients. J Surg Oncol 1992; 49: 156-162.

22. van der Pijl H, Frissen PH. Experience with a totally implantable venous access device (Port-A-Cath) in patients with AIDS. AIDS 1992; 6: 709-713.

23. Groeger JS, Lucas AB, Thaler HT, et al. Infectious morbidity associated with long-term use of venous access devices in patients with cancer. Ann Intern Med 1993; 119: 1168-1174.

24. Timsit JF, Sebille V, Farkas JC, Misset B, Martin JB, Chevret S, et al. Effects of subcutaneous tunneling on internal jugular catheter-related sepsis in critically ill patient: a prospective randomised multicenter study. JAMA 1996; 276: 1416-1420.

25. Timsit JF, Bruneel F, Cheval C, Mamzer MF, Garrouster-Orgeas M, Wolff M, et al. Use of tunneled femoral catheters to prevent catheter-related infection: a randomised controlled trial. Ann Intern Med 1999; 130: 729-735.

26. Randolph A, Cook D, Gonzales C, Brun-Buisson C. Tunneling short-term central venous catheters to prevent catheter-related infection: A meta-analysis of randomized controlled trials. Crit Care Med 1998; 26(8): 1452-1457.

1 2 Antimicrobial impregnated catheters and cuffs 3 Some catheters and cuffs are marketed as anti-infective and are coated or 4 impregnated with antimicrobial or antiseptic agents, e.g. chlorhexidine/silver 5 sulfadiazine, minocycline/ rifampin, platinum/silver, and ionic silver in subcutaneous 6 collagen cuffs attached to CVC. Evidence reviewed by HICPAC1-11 indicated that the 7 use of antimicrobial or antiseptic-impregnated CVC in adults whose catheter is 8 expected to remain in place for more than five days could decrease the risk for CR-9 BSI. This may be cost-effective in high-risk patients (intensive care, burn and 10 neutropenic patients) and in other patient populations in whom the rate of CR-BSI 11 exceeds 3.3 per 1,000 catheter days despite implementing a comprehensive strategy 12 to reduce rates of CR-BSI.1 13 14 A meta-analysis of 23 RCTs published between 1988-1999 included data on 4,660 15 catheters (2,319 anti-infective and 2,341 control).12 Eleven of the trials in this meta-16 analysis were conducted in intensive care unit (ICU) settings; four among oncologic 17 patients, two among surgical patients; two among patients receiving TPN and four 18 among other patient populations. Study authors concluded that antibiotic and 19 chlorhexidine-silver sulfadiazine coatings are anti-infective for short (approximately 20 one week) insertion time. For longer insertion times, there was no data on antibiotic 21 coating, and there is evidence of lack of effect for first generation chlorhexidine-silver 22 sulfadiazine coating. For silver-impregnated collagen cuffs, there is evidence of lack 23 of effect for both short- and long-term insertion. 24 25

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Second generation chlorhexidine/silver sulfadiazine catheters with chlorhexidine 1 coating on both the internal and external luminal surfaces are now available. The 2 external surface of these catheters have three times the amount of chlorhexidine and 3 extended release of the surface bound antiseptics than that in the first generation 4 catheters (which are coated with chlorhexidine/silver sulfadiazine only on the external 5 luminal surface). Early studies indicated that the prolonged anti-infective activity 6 associated with the second generation catheters improved efficacy in preventing 7 infections. 13 8 9 A SR and economic evaluation in 2006 concluded that rates of CR-BSI are 10 statistically significantly reduced when an antimicrobial CVC was used. Studies in 11 this review report the best effect when catheters were treated with 12 minocycline/rifampin, or internally and externally treated with silver or 13 chlorhexidine/silver sulfadiazine. A trend to statistical significance was seen in 14 catheters only extraluminally coated. Investigation of other antibiotic treated 15 catheters is limited to single studies with non-significant results.14 16 17 We identified one additional SR and one RCT in our updated search. A collaborative 18 network meta-analysis of CVC use in adults conducted in 2010 indicated that 19 rifampicin-based impregnated CVC was the only type of impregnated/coated CVC 20 that reduced catheter colonisation and CR-BSI compared with standard CVC. 15 In a 21 single blind non-inferiority trial, authors concluded that CVC coated with 5-fluorouracil 22 were non-inferior to chlorhexidine and silver sulfadiazine coated CVCs with respect 23 to the incidence of catheter colonisation (2.9% vs. 5.3%, respectively).16 24 25 Expert guidelines recommend the use of a chlorhexidine/sulfadiazine or minocycline/ 26 rifampin-impregnated CVC in patients whose catheter is expected to remain in place 27 more than five days if CLABSI is not decreasing following the implementation of a 28 comprehensive strategy to reduce rates of CLABSI. 17 29 30 31 IVAD 9

Use an antimicrobial impregnated central venous access device for adult patients whose catheter is expected to remain in place for > 5 days if rates remain above the agreed benchmark despite implementing a comprehensive strategy to reduce catheter related bloodstream infection. [Revised recommendation]

Class A

32 33 References 34 1. Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of central venous catheter related

bloodstream infection by use of an antiseptic-impregnated catheter. A randomized controlled trial. Ann Intern Med 1997; 127: 257-66.

2. chlorhexidine and silver-sulfadiazine impregnated central venous catheters for the prevention of bloodstream infection in leukaemic patients: a randomized controlled trial. J Hosp Infect 1997; 37: 145-156.

3. Heard SO, Wagle M, Vijayakumar E, McLean S, Brueggemann A, Napolitano LM, Edwards LP, -lumen central venous catheters coated

with chlorhexidine and sliver sulfadiazine on the incidence of catheter-related bacteremia. Arch Intern Med 1998; 158(1): 81-87.

4. -analysis dealing with the effectiveness of chlorhexidine and silver-sulfadiazine impregnated central venous catheters. J Hosp Infect 1998; 40: 166-168.

5. Oda T, Hamasaki J, Kanda N, Mikami K. Anaphylactic shock induced by an antiseptic-coated central venous catheter. Anesthesiology 1997; 87: 1242-1244.

6. Veenstra DL, Saint S, Sullivan S. Cost-effectiveness of antiseptic-impregnated central venous

89

catheters for the prevention of catheter-related bloodstream infection. JAMA 1999; 282(6): 554-560.

7. Raad I, Darouiche R, Dupuis J, Abi-Said D, Gabrielli A, Hachem R, Harris R, Jones J, Buzaid A, Robertson C, Shenaq S, Curling P, Burke T, Ericsson C, the Texas Medical Center Catheter Study Group. Central venous catheters coated with minocycline and rifampin for the prevention of catheter-related colonization and bloodstream infections. A randomized, double-blind trial. Ann Intern Med. 1997; 127: 267-74.

8. Colin GR. Decreasing catheter colonization through the use of an antiseptic-impregnated catheter: a continuous quality improvement project. Chest 1999; 115: 1632-40.

9. Darouiche RO, Raad I, Heard S, Thornby JL, Wenker OC, Gabrielli A, Berg J, Khardori N, Hanna H, Henchem R, Harris R, Mayhall G. A comparison of two antimicrobial-impregnated central venous catheters. N Engl J Med 1999; 340: 1-8.

10. Veenstra DL, Saint S, Saha S, Lumley T, Sullivan S. Efficacy of antiseptic-impregnated central venous catheters in preventing catheter related bloodstream infection: a meta-analysis. JAMA 1999; 281(3): 261-267.

11. Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med 2000 March 7; 132(5): 391-402.

12. Walder B, Pittet D, Tramer M. Prevention of bloodstream infections with central venous catheters

treated with anti-infective agents depends on catheter type and insertion time: evidence from a meta-analysis. Infect Control Hosp Epidemiol Dec 2002; 23(12): 748-56.

13. containing chlorhexidine/silver sulfadiazine extends protection against catheter infections in vivo. Antimicrob Agents Chemother 2001; 45: 1535-8.

14. Hockenhull JC, Dwan K, Boland A, Smith G, Bagust A, Dickson R, Dundar Y, Gambol C, McCleod C, Walley T. The clinical and cost effectiveness of central venous catheters treated with anti-microbial agents in preventing bloodstream infections: a systematic review and economic evaluation. Health Techno Assess Rep 2006. Available online at: http://www.hta.nhsweb.nhs.uk/ (Accessed 4 June 2013).

15. Wang H, Huang T, Jing J, Jin J, Wang P, Yang M, Cui W, Zheng Y, Shen H. Effectiveness of different cental venous catheters for catheter-related infections: a network meta-analysis. J Hosp Infect 2010; 76(1): 1-1.

16. Walz JM. Avelar RL. Longtine KJ. Carter KL. Mermel LA. Heard SO. 5-FU Catheter Study Group. Anti-infective external coating of central venous catheters: a randomized, noninferiority trial comparing 5-fluorouracil with chlorhexidine/silver sulfadiazine in preventing catheter colonization. Crit Care med. 2010; 38(11): 2095-2102.

17. ger EP., Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the Prevention of Intravascular Catheter Related Infections. Clin Infect Dis 2002; 35: 1281-207.

1 4.6 Selection of Catheter Insertion Site 2 3 4 The site at which a vascular access catheter is placed can influence the subsequent 5 risk of CR-BSI because of variation in both the density of local skin flora and the risk 6 of thrombophlebitis. Central venous catheters are generally inserted in the 7 subclavian, jugular or femoral veins, or peripherally inserted into the superior vena 8 cava by way of the major veins of the upper arm, i.e. the cephalic and basilar veins of 9 the antecubital space. Peripheral venous catheters are normally inserted in the 10 upper extremity, although alternatives, such as the foot and scalp, may be used in 11 children and babies. 12 13 Subclavian, jugular and femoral placements 14 HICPAC examined a number of studies comparing insertion sites and concluded that 15 CVC inserted into subclavian veins had a lower risk for catheter-related infection than 16 those inserted into either jugular or femoral veins.1-11 Guideline developers 17 suggested that internal jugular insertion sites may pose a greater risk for infection 18 because of their proximity to oropharyngeal secretions and because CVC at this site 19 are difficult to immobilise.12 However, mechanical complications associated with 20 catheterisation might be less common with internal jugular than with subclavian vein 21 insertion. 22

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1 Femoral catheters have been demonstrated to have relatively high colonisation rates 2 compared to subclavian and internal jugular sites when used in adults, and current 3 guidelines suggest the femoral site should be avoided because it is presumed to be 4 associated with both a higher risk of deep vein thrombosis (DVT) and catheter-5 related infection than are internal jugular or subclavian catheters.4,9-11,13-15 One study 6 also found that the risk of infection associated with catheters placed in the femoral 7 vein is accentuated in obese patients.2 Thus, in adult patients, a subclavian site is 8 preferred for infection control purposes, although other factors, e.g. the potential for 9 mechanical complications, risk for subclavian vein stenosis, and catheter-operator 10 skill, should be considered when deciding where to place the catheter. 11 12 Two meta-analyses16,17 indicate that the use of real-time two dimensional ultrasound 13 for the placement of CVC substantially reduced mechanical complications, compared 14 with the standard landmark placement technique. Consequently, the use of 15 ultrasound may indirectly reduce the risk of infection by facilitating mechanically 16 uncomplicated subclavian placement. In the UK, guidelines from the National 17 Institute for Health and Clinical Excellence (NICE) provide recommendations for the 18 2D placement of CVC.18 19 20 Antecubital placement 21 Peripherally inserted central venous catheters (PICC) may be used as an alternative 22 to subclavian or jugular vein catheterisation. These are inserted into the superior 23 vena cava by way of the major veins of the upper arm. HICPAC indicate that they 24 are less expensive, associated with fewer mechanical complications, e.g. thrombosis, 25 haemothorax, infiltration and phlebitis, and easier to maintain than short peripheral 26 venous catheters, due to a reduced need for frequent site rotation. Additionally, 27 previous evidence examined by HICPAC suggested that PICC are associated with a 28 lower rate of infection than that associated with other non-tunnelled CVC,19,20 perhaps 29 because the skin at the antecubital fossa is less moist and oily and colonised by 30 fewer microorganisms than the chest and neck12,20 and because an antecubital 31 placement removes the catheter away from endotracheal and nasal secretions. 32 Finally, HICPAC noted that further studies were needed to adequately determine how 33 long PICC could be safely left in place and to determine whether routine replacement 34 influenced the risk of associated infection. 21 In a prospective cohort study using data 35 from two randomised trials and a SR to estimate rates of PICC-related bloodstream 36 infection in hospitalised patients, authors concluded that PICC used in high-risk 37 hospitalised patients are associated with a rate of CR-BSI similar to conventional 38 CVC placed in the internal jugular or subclavian veins (2 to 5 per 1,000 catheter-39 days). 22 40 41 Peripheral venous catheters 42 To reduce the risk of catheter related-infection and phlebitis, it is preferable to use an 43 upper-extremity site for inserting a PVC in adults and to replace a lower extremity to 44 an upper extremity site as soon as possible.12 In paediatric patients, the upper or 45 lower extremity and the scalp (in young infants) can be used for siting a PVC. 23,24 46 47 We identified a SR and meta-analysis from 2012,25 in which investigators reviewed 48 two RCTs, eight cohort studies and data from a national HCAI programme. These 49 provided evidence that the selection of insertion site is not a significant factor in 50 preventing CR-BSI. The meta-analysis demonstrated no difference in the risk of CR-51 BSI between the femoral, subclavian and internal jugular sites, having removed two 52 studies that were statistical outliers. The authors concluded that a pragmatic 53 approach to site selection for central venous access, taking into account underlying 54 disease (e.g. renal disease), the expertise and skill of the operator and the risks 55

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associated with placement, should be utilised.25 Catheters placed in the internal 1 jugular and femoral site should be placed under direct ultrasound guidance, as this 2 technique reduces the risk of placement complications.18 3 4 5 IVAD10 In selecting an appropriate intravascular insertion site,

assess the risks for infection against the risks of mechanical complications and patient comfort. [Revised wording]

Class D/ GPP

IVAD11 Unless medically contraindicated, use the upper

extremity for nontunnelled catheter placement. [Revised recommendation]

Class C

IVAD12 Use implantable access devices for patients who

require long-term, intermittent vascular access. For patients requiring regular or continuous access, a tunnelled central venous access device is preferable. [No change]

Class C

6 7 References 8 1. Mermel LA, McCormick RD, Springman SR, Maki DG. The pathogenesis and epidemiology of 9

catheter-related infection with pulmonary artery Swan-Ganz catheters: a prospective study utilizing 10 molecular subtyping. Am J Med 1991; 91(suppl): S197 S205. 11

2. Parienti JJ, Thirion M, Megarbane B, et al. Femoral vs jugular venous catheterization and risk of 12 nosocomial events in adults requiring acute renal replacement therapy: a randomized controlled 13 trial. JAMA 2008; 299: 2413 22. 14

3. Moretti EW, Ofstead CL, Kristy RM, Wetzler HP. Impact of central venous catheter type and 15 methods on catheter-related colonization and bacteraemia. J Hosp Infect 2005; 61: 139 45. 16

4. Nagashima G, Kikuchi T, Tsuyuzaki H, et al. To reduce catheter-related bloodstream infections: is 17 the subclavian route better than the jugular route for central venous catheterization? J Infect 18 Chemother 2006; 12: 363 5. 19

5. Ruesch S, Walder B, Tramer MR. Complications of central venous catheters: internal jugular versus 20 subclavian access a systematic review. Crit Care Med 2002; 30: 454 60. 21

6. Sadoyama G, Gontijo Filho PP. Comparison between the jugular and subclavian vein as insertion 22 site for central venous catheters: microbiological aspects and risk factors for colonization and 23 infection. Braz J Infect Dis 2003; 7: 142 8. 24

7. Heard SO, Wagle M, Vijayakumar E, et al. Influence of triple-lumen central venous catheters coated 25 with chlorhexidine and silver sulfadiazine on the incidence of catheter-related bacteremia. Arch 26 Intern Med 1998; 158: 81 7. 27

8. Richet H, Hubert B, Nitemberg G, et al. Prospective multicenter study of vascular-catheter-related 28 complications and risk factors for positive central-catheter cultures in intensive care unit patients. J 29 Clin Microbio 1990; 28: 2520 5. 30

9. Safdar N, Kluger DM, Maki DG. A review of risk factors for catheter-related bloodstream infection 31 caused by percutaneously inserted, noncuffed central venous catheters: implications for preventive 32 strategies. Medicine (Baltimore) 2002; 81: 466 79. 33

10. Lorente L, Jimenez A, Iribarren JL, Jimenez JJ, Martin MM, Mora ML. The micro-organism 34 responsible for central venous catheter related bloodstream infection depends on catheter site. 35 Intensive Care Med 2006; 32: 1449 50. 36

11. Traore O, Liotier J, Souweine B. Prospective study of arterial and central venous catheter 37 colonization and of arterial-and central venous catheter-related bacteremia in intensive care units. 38 Crit Care 2005; 33: 1276 80. 39

12. 40 Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 41 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-42 Related Infections. Clin Infect Dis 2011 May; 52(9): e162-93. 43

13. Merrer J, De Jonghe B, Golliot F, et al. Complications of femoral and subclavian venous 44 catheterization in critically ill patients:a randomized controlled trial. JAMA 2001; 286: 700 7. 45

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14. Goetz AM, Wagener MM, Miller JM, Muder RR. Risk of infection due to central venous catheters: 1 effect of site of placement and catheter type. Infect Control Hosp Epidemiol 1998; 19: 842 5. 2

15. Deshpande KS, Hatem C, Ulrich HL, et al. The incidence of infectious complications of central 3 venous catheters at the subclavian, internal jugular, and femoral sites in an intensive care unit 4 population. Crit Care Med 2005; 33:13 20; discussion 234 5. 5

16. Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central 6 venous catheters:a meta-analysis of the literature. Crit Care Med 1996; 24: 2053 8. 7

17. Hind D, Calvert N, McWilliams R, et al. Ultrasonic locating devices for central venous cannulation: 8 meta-analysis. BMJ 2003; 327: 361. 9

18. National Institute for Clinical Excellence. Ultrasound locating devices for place central venous 10 catheters (No. 49).September 2002. Available from: http://www.nice.org.uk (Accessed 7 June 2013) 11

19. Raad I, Davis S, Becker M, et al. Low infection rate and long durability of nontunneled silastic 12 catheters. A safe cost-effective alternative for long-term venous access. Archives of Intern Med 13 1993; 153: 1791-1796. 14

20. Ryder MA. Peripheral access options. Surg Oncol Clinic N Am 1995; 4: 395-427. 15 21. Noble WC. Skin microbiology: coming of age. J Med Microbio 1984; 17: 1-12. 16 22. Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central 17

venous catheters used in hospitalized patients. Chest 2005; 128: 489-495. 18 23. Maki DG, Goldman DA, Rhame FS. Infection control in intravenous therapy. Ann Intern Med 1973; 19

79: 867 87. 20 24. Band JD, Maki DG. Steel needles used for intravenous therapy. Morbidity in patients with 21

hematologic malignancy. Arch Intern Med 1980; 140: 31 4. 22 25. Marik PE, Flemmer M, Harrison W. The risk of catheter-related bloodstream infection with femoral 23

venous catheters as compared to subclavian and internal jugular venous catheters: A systematic 24 review of the literature and meta-analysis. Crit Care Med 2012; 40: 2479 2485. 25

26 27 4.7 Maximal Sterile Barrier Precautions during Catheter 28 Insertion 29 30 31 Using maximal sterile barrier precautions during the placement of central 32 venous catheters will significantly reduce the risk of infection 33 The importance of strict adherence to hand decontamination and aseptic technique 34 as the cornerstone for preventing catheter-related infection is widely accepted. 35 Although this is considered adequate for preventing infections associated with the 36 insertion of short peripheral venous catheters, it is recognised that central venous 37 catheterisation carries a significantly greater risk of infection. 38 39 Studies examined by HICPAC concluded that if maximal sterile barrier (MSB) 40 precautions were consistently used during CVC insertion, catheter contamination and 41 subsequent catheter-related infections could be significantly minimised.1-4 A 42 prospective randomised trial that tested the efficacy of MSB to reduce infections 43 associated with long-term, nontunnelled subclavian silicone catheters, compared with 44 routine procedures, found that they significantly decreased the risk of CR-BSI.1 45 46 Maximal sterile barrier precautions involve wearing sterile gloves and gown, a cap, 47 mask and using a full body sterile drape (similar to the drapes used in the operating 48 theatre) during insertion of the catheter.5 However, there is no specific evidence that 49 wearing a facemask or cap during catheter insertion is important in preventing CR-50 BSI. 51 52 It has been generally assumed that CVC inserted in the operating theatre pose a 53 lower risk of infection than those inserted on inpatient wards or other patient care 54 areas.6 However, data examined by HICPAC from two prospective studies suggests 55 that the difference in risk of infection depended largely on the magnitude of barrier 56 protection used during catheter insertion, rather than the surrounding environment, 57 i.e. ward versus operating room.1,2 58 59

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A SR of the value of MSB to prevent CLABSI defined the components as: the person 1 inserting the catheter should wear a head cap, facemask, sterile body gown and 2 sterile gloves and use a full-size sterile drape. Their search identified 95 articles 3 discussing the prevention of CLABSI. The majority of these articles were narrative 4 reviews or consensus statements. Three primary research studies, differing in 5 design, patient population and clinical settings, comparing infection outcomes using 6 MSB with less stringent barrier techniques, concluded that the use of MSB resulted in 7 a reduction in catheter-related infections. The authors concluded that using MSB 8 appears to decrease transmission of microorganisms, delay colonisation and reduce 9 the rate of HCAI. They also suggested that biological plausibility and the available 10 evidence support using MSB during routine insertion of a CVC to minimise the risk of 11 infection. They recommended that, given the lack of adverse patient reactions, the 12 relatively low cost of MSB and the high cost of CR-BSI, it is probable that MSB will 13 prove to be a cost-effective, or even a cost-saving intervention. 7 14 15 Neither we nor HICPAC guideline developers identified any additional evidence of 16 acceptable quality whilst updating our systematic reviews. 17 18 19 IVAD13 Use maximal sterile barrier precautions, including a

sterile gown, sterile gloves, and a large sterile drape, for the insertion of central venous access devices. [No change]

Class C

20 21 References 22 1. Raad II, Hohn DC, Gilbreath BJ, Suleiman N, Hill LA, Bruso PA, Marts K, Mansfield PF, Bodey

GP.Prevention of central venous catheter-related infections by using maximal sterile barrier precautions during insertion.Infect Control Hosp Epidemiol 1994; 15: 231 8.

2. Mermel LA, McCormick RD, Springman SR, Maki DG. The pathogenesis and Epidemiology of catheter-related infection with pulmonary artery Swan-Ganz catheters: a prospective study utilizing molecular subtyping. Am J Med 1991; 91(suppl 3B): 197S-205S.

3. Sherertz RJ, Ely EW, Westbrook DM, et al. Education of physicians in-training can decrease the risk for vascular catheter infection. Ann Intern Med 2000; 132: 641 8.

4. Carrer S, Bocchi A, Bortolotti M, Braga N, Gilli G, Candini M, Tartari S. Effect of different sterile barrier precautions and central venous catheter dressing on the skin colonization around the insertion site. Minerva Anestesiol 2005; 71: 197 206.

5. Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-Related Infections. Clin Infect Dis 2011 May; 52(9): e162-93.

6. Pearson ML. Hospital Infection Control Practices Advisory Committee. Guideline for Prevention of Intravascular-device-related Infections. Infect Control Hosp Epidemiol 1996 July; 17(7): 438-473.

7. Hu KK, Lipsky BA, Veenstra DL, Saint S. Using maximal sterile barriers to prevent central venous catheter-related infection: A systematic evidence-based review. Am J Infect Control 2004; 32: 142-6.

4.8 Cutaneous Antisepsis 23 24 25 Appropriate preparation of the insertion site will reduce the risk of catheter-26 related infection 27 Microorganisms that colonise catheter hubs and the skin surrounding the vascular 28 catheter insertion site are the cause of most CR-BSIs.1-3 As the risk of infection 29 increases with the density of microorganisms around the insertion site, skin 30 cleansing/antisepsis of the insertion site is therefore one of the most important 31 measures for preventing catheter-related infections.4 Since the early 1990s, 32

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research has focused on confirming the most effective antiseptic agent for skin 1 preparation prior to the insertion of intravascular devices, in order to prevent 2 catheter-related infections, especially CR-BSI. In the UK, clinicians principally used 3 alcohol, or either povidone iodine (PVI) or chlorhexidine gluconate (CHG), in various 4 strengths, and the latter two as either aqueous or alcoholic solutions. During the last 5 several years, alcoholic CHG has become the standard solution for skin cleansing 6 prior to the insertion of intravascular access devices. The widespread use of this 7 solution is based on a variety of well-conducted studies that, in general, show that 8 CHG is superior to other skin disinfectants for pre-insertion skin cleansing in 9 contributing to multifaceted strategies for minimising the risk of CR-BSI. Alcoholic 10 solutions of CHG combine the benefits of quick drying, rapid action and excellent 11 residual activity. 12 13 A prospective randomised trial of agents used for cutaneous antisepsis demonstrated 14 that 2% aqueous CHG was superior to either 10% PVI or 70% alcohol for preventing 15 central venous and arterial catheter-related infections.5 A further prospective, 16 randomised trial demonstrated that a 4% alcohol-based solution of 0.25% CHG and 17 0.025% benzalkonium chloride was more effective in preventing central venous or 18 arterial catheter colonisation and infection than 10% PVI.6 19 20 The use of 5% PVI solution in 70% ethanol has been shown to be associated with a 21 substantial reduction of catheter-related colonisation and infection compared with 22 10% aqueous PVI. 7 Clinicians may find this useful for those patients for whom 23 alcoholic CHG is contra-indicated. 24 25 A meta-analysis of CHG compared with PVI solution for vascular catheter-site care 26 suggested that CHG preparations reduced the risk of catheter-related infection by 27 49% (95% CI .28 to .88).8 Additionally, an economic decision analysis based on 28 available evidence suggested that the use of CHG, rather than PVI, for skin care 29 would result in a 1.6% decrease in the incidence of CR-BSI, a 0.23% decrease in the 30 incidence of death, and finacial savings per catheter used. 9 31 32

n 33 lipids) the skin before catheter insertion and during routine dressing changes has, in 34 the past, been considered a standard component of many hyperalimentation 35 protocols. However, there was no evidence available to HICPAC to show that the 36 use of these agents provided any protection against catheter-related infection, and 37 their use could greatly increase local inflammation and patient discomfort.4 38 39 Several studies were examined that focused on the application of antimicrobial 40 ointments to the catheter site at the time of catheter insertion, or during routine 41 dressing changes, to reduce microbial contamination of catheter insertion sites.3 42 Reported efficacy in preventing catheter-related infections by this practice yielded 43 contradictory findings.9-14 There was also concern that the use of polyantibiotic 44 ointments that were not fungicidal could significantly increase the rate of colonisation 45 of the catheter by Candida species.15,16 46 47 We identified one recent SR of the clinical efficacy and perceived role of CHG in skin 48 antisepsis that included studies about intravascular access.17 The authors suggested 49 a potential source of bias, as many studies have overlooked the importance of 50 alcohol when assessing the efficacy of CHG. The authors assessed the attribution of 51 CHG in each study as correct, incorrect or intermediate. Studies were scored and 52 analysis was performed separately to assess CHG efficiency. Authors concluded 53 that CHG is more efficient than PVI or any other technique alone, but that the 54 presence of alcohol provides additional benefit. The authors suggested that vascular 55

95

catheters require an immediate activity of antiseptic provided by alcohol prior to 1 insertion. They also require a long lasting antiseptic, as they stay in place for 2 prolonged periods of time. Chlorhexidine gluconate meets this requirement well. 3 4 5 IVAD 14

Decontaminate the skin site with a single use application of 2% chlorhexidine gluconate in 70% isopropyl alcohol prior to the insertion of a central venous access device. Allow the antiseptic to dry before inserting the central venous access device. [Revised wording]

Class A

IVAD 15

Use a single use application of alcoholic povidone-iodine solution for patients with a history of chlorhexidine sensitivity. Allow the antiseptic to dry before inserting the central venous access device. [Revised wording]

Class D/ GPP

IVAD 16

Do not apply organic solvents, e.g., acetone, ether, to the skin before the insertion of a central venous access device. [No change]

Class D/ GPP

IVAD 17

Do not routinely apply antimicrobial ointment to the catheter placement site prior to insertion. [No change]

Class D/ GPP

6 7 References 8 1. Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med 2000 March 7;

132(5): 391-402. 2. Fletcher SJ, Bodenham AR. Catheter-related sepsis: an overview Part 1. Br J Inten Care 1999;

9(2): 46-53. 3. Mimoz O, Pieroni L, Lawrence C, Edouard A, Costa Y, Samii K, Brun-Buisson C. Prospective,

randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter colonization and infection in intensive care unit patients. Crit Care Med 1996; 24(11): 1818-1823.

4. Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-Related Infections, Clin Infect Dis 2011 May; 52(9): e162-93.

5. Maki DG, Ringer M, Alvarado CJ. Prospective randomized trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet 1991; 338: 339-343.

6. Mimoz O, Pieroni L, Lawrence C, Edouard A, Costa Y, Samii K, Brun-Buisson C. Prospective, randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter colonization and infection in intensive care unit patients. Crit Care Med 1996; 24(11): 1818-1823.

7. Parienti JJ, du Cheyron D, Ramakers M, Malbruny B, Leclercq R, Le Coutour X, Charbonneau P, (for) Members of the NACRE Study Group. Alcoholic povidone-iodine to prevent central venous catheter colonization: a randomized unit-crossover study. Crit Care Med 2004; 32(3): 708-13.

8. Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med 2002; 136: 792 801.

9. Larsen E. Guideline for use of topical antimicrobial agents. Am J Infect Control 1988; 16: 253-66. 10. Rannem T, Ladefoged K, Hegnhoj F, Hylander Moller E, Bruun B, Farnum S. Catheter-related

sepsis in long-term parenteral nutrition with Broviac catheters. An evaluation of different disinfectants. Clin Nutr 1990; 9: 131-136.

11. Prager RL, Silva J. Colonization of central venous catheters. South Med J 1984; 77: 458-461. 12. Moran JM, Atwood RP, Rowe MI. A clinical and bacteriologic study of infections associated with

venous cutdowns. NEJM 1965; 272: 554-560. 13. Norden CW. Application of antibiotic ointment to the site of venous catheterization: a controlled trial.

J Infect Dis 1969; 120: 611-5.

96

14. Zinner SH, Denny-Brown BC, Braun P, Burke JP, Toala P, Kass EH. Risk of infection with indwelling intravenous catheters: effect of application of antibiotic ointment. J Infect Dis 1969; 120: 616-619.

15. Jarrad MM, Freeman JB. The effects of antibiotic ointments and antiseptics on the skin flora beneath subclavian catheter dressings during intravenous hyperalimentation. J Surg Res 1977; 22: 520-526.

16. Maki DG, Band JD. A comparative study of polyantibiotic and iodophor ointment in prevention of vascular catheter-related infection. Am J Med 1981; 70: 739-744.

17. Maiwald, M.; Chan, E.S., 2012. The Forgotten Role of Alcohol: A Systematic Review and Meta-Analysis of the Clinical Efficacy and Perceived Role of Chlorhexidine in Skin Antisepsis. PLoS ONE; 7(9): e44277.

1 2 4.9 Catheter and Catheter Site Care 3 4 5 Infections can be minimised by good catheter and insertion site care 6 The safe maintenance of an intravascular catheter and relevant care of the insertion 7 site are essential components of a comprehensive strategy for preventing catheter-8

9 and connection port, the use of an appropriate intravascular catheter site dressing 10 regimen and using flush solutions to maintain the patency of the catheter. 11 12 Choose the right dressing and disinfectant for insertion sites to minimise 13 infection 14 Following placement of a peripheral or venous intravascular catheter, a dressing is 15 used to protect the insertion site. Because occlusive dressings trap moisture on the 16 skin and provide an ideal environment for the rapid growth of local microflora, 17 dressings for insertion sites must be permeable to water vapour.1 The two most 18 common types of dressings used for insertion sites are sterile, transparent, semi-19 permeable polyurethane dressings coated with a layer of an acrylic adhesive 20

ze and tape dressings. Transparent dressings are 21 permeable to water vapour and oxygen and impermeable to microorganisms. 22 23 HICPAC reviewed the evidence related to which type of dressing provided the 24 greatest protection against infection, including the largest controlled trial of dressing 25 regimens on PVCs2, a meta-analysis comparing the risk of CR-BSI using transparent 26 versus gauze dressings3 and a Cochrane review.4 All concluded that the choice of 27 dressing can be a matter of preference. If blood is oozing from the catheter insertion 28 site, a gauze dressing might be preferred. 29 30 Gauze dressings are not waterproof and require frequent changing in order to inspect 31 the catheter site. They are rarely useful in patients with long-term intravascular 32 catheters. Sterile transparent, semi-permeable polyurethane dressings have become 33 a popular means of dressing catheter insertion sites. They reliably secure 34 intravascular catheters, permit continuous visual inspection of the catheter site, allow 35 patients to bathe and shower without saturating the dressing and require less 36 frequent changing than that required for standard gauze and tape dressings, thus 37 saving personal time. 38 39 We identified one SR and meta-analysis, undertaken as part of a quality 40 improvement collaborative, which synthesised the effects of the routine use of CHG-41 impregnated sponge dressings in reducing centrally inserted CR-BSI.5 The 42 reviewers concluded that CHG-impregnated sponge dressings are effective in 43 preventing CR-BSI (OR 0.43; 95% CI 0.29 to 0.64) and catheter colonisation (OR 44 0.43; 95% CI 0.36. to 0.51). 45

97

1 A SR and meta-analysis of the efficacy of daily bathing with CHG for reducing 2 bloodstream infections was also identified.6 Twelve studies were included: one RCT, 3 one cluster non-randomised controlled trial and ten controlled interrupted time series, 4 all performed in adult acute care settings, five of which reported insertion technique, 5 including the use of CHG. There was a high level of clinical heterogeneity and 6 moderate statistical heterogeneity, which remained following a subgroup analysis by 7 type of CHG formulation. The authors concluded that among ICU patients, daily 8 CHG bathing with CHG liquid (OR 0.47; 95% CI 0.31 to 0.71) or cloths (OR 0.41; 9 95% CI 0.25 to 0.65) reduces the risk of CR-BSI. Similar benefit is obtained 10 regardless of whether CHG cloths or liquid preparation is used (OR 0.44; 95% CI 11 0.44 to 0.59). This review is not generalisable to paediatric care. 12 13 A single RCT compared the efficacy of two commercially available alcohol based 14 antiseptic solutions for preparation and care of CVC insertion sites, with and without 15 octenidine dihydrochloride.7 Data was collected from 2002-2005 and published in 16 2009. Authors concluded that octenidine in alcoholic solution to be a better option 17 than alcohol alone for the prevention of CVC-associated infections and may be as 18 effective as CHG in practice, but that a comparative trial is needed. 19 20 21 22 IVAD 18

Use a sterile, transparent, semi-permeable polyurethane dressing to cover the intravascular insertion site. [Revised wording]

Class D/ GPP

IVAD 19

Transparent, semi-permeable polyurethane dressings should be changed every 7 days, or sooner if they are no longer intact or moisture collects under the dressing. [No change]

Class D/ GPP

IVAD 20

Use a sterile gauze dressing if a patient has profuse perspiration or if the insertion site is bleeding or oozing and changed when inspection of the insertion site is necessary or when the dressing becomes damp, loosened or soiled. The continued need for a gauze dressing should be assessed daily and replaced by a transparent dressing as soon as possible. [Revised wording]

Class D/ GPP

23 IVAD 21

Do not change the transparent, semi-permeable polyurethane dressings applied to peripheral vascular catheter insertion site unless the integrity of the dressing is disturbed or there is pooling of fluid/blood under the dressing. [New recommendation]

Class D/ GPP

IVAD 22

Dressings used on tunnelled or implanted catheter insertion sites should be replaced every 7 days until the insertion site has healed, unless there is an indication to change them sooner. A dressing is no longer required once the insertion site is healed. [Revised recommendation]

Class D/ GPP

98

1 2 References 3 1. Fletcher SJ, Bodenham AR. Catheter-related sepsis: an overview Part 1. Br J Inten Care 1999;9

(2): 46-53. 2. Maki DG, Ringer M. Evaluation of dressing regimens for prevention of infection with peripheral

intravenous catheters. Gauze, a transparent polyurethane dressing, and an iodophor-transparent dressing. JAMA 1987; 258: 2396 403.

3. Hoffmann KK, Weber DJ, Samsa GP, Rutala WA. Transparent polyurethane film as an intravenous catheter dressing. A meta-analysis of the infection risks. JAMA 1992; 267: 2072 6.

4. for central venous catheters (Review). Cochrane Database Syst Rev 2003. Issue 3, p. 1-18.

5. Chan RJ, Northfield S, Alexander A, Rickard C. Using the collaborative evidence based practice model: a systematic review and uptake of chlorhexidine-impregnated sponge dressings on central venous access devices in a tertiary cancer centre. Aust J Cancer Nurs 2012; 13(2): 10-15.

6. -Price LS, Safdar N. The efficacy of daily bathing with chlorhexidine for reducing healthcare-associated bloodstream infections: a meta-analysis. Infect Control Hosp Epidemiol 2012; 33(3): 257-267.

7. Dettenkofer M, Wilson C, Gratwohl A, Schmoor C, Bertz H, Frei R, Heim D, Luft D, Schultz S, Widmer AF. Skin disinfection with octenidine dihydrochloride for central venous catheter site care: a double-blind, randomized, controlled trial. Clin Microbiol Infect 2010; 16: 600-606.

Use an appropriate antiseptic agent for disinfecting the catheter insertion site 4 during dressing changes 5 Research previously described in this guideline has described the superior 6 effectiveness of using CHG to minimise the density of microorganisms around 7 vascular catheter insertion sites.1-3 Consequently, alcoholic CHG is now being widely 8 used in the UK for disinfecting the insertion site during dressing changes. 9 10 Studies focused on the use of antimicrobial ointment applied under the dressing to 11 the catheter insertion site to prevent catheter-related infection do not clearly 12 demonstrate efficacy.4,5 13 14 Most modern intravascular catheters and other catheter materials are generally 15 alcohol-resistant, i.e. they are not damaged by contact with alcohol. However, 16 alcohol, and other organic solvents and oil-based ointments and creams, may 17 damage some types of polyurethane and silicon catheter tubing, e.g. some catheters 18

19 disinfectants that are compatible with specific catheter materials must therefore be 20 followed. 21 22 23 IVAD 23

Use 2% chlorhexidine gluconate in 70% isopropyl alcohol (or alcoholic povidone iodine for patients with a sensitivity to chlorhexidine) to clean the catheter insertion site during dressing changes, and allow to air dry unless device specific recommendations from the manufacturer indicate otherwise. [Revised wording]

Class A

24 IVAD 24

Single use sachets of antiseptic solution or single use antiseptic-impregnated swabs or wipes should be used to disinfect the insertion site. [Revised wording]

Class D/ GPP

IVAD 25

Do not apply antimicrobial ointment to catheter insertion sites as part of routine catheter site care.

Class D/ GPP

99

[No change] IVAD 26

Healthcare workers should ensure that intravascular catheter-site care is compatible with catheter materials (tubing, hubs, injection ports, luer connectors and extensions) and carefully check

recommendations. [Revised wording]

Class D/ GPP

1 References 2 1. Maki DG, Ringer M, Alvarado CJ. Prospective randomized trial of povidone-iodine, alcohol, and 3

chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet 4 1991; 338: 339-343. 5

2. Mimoz O, Pieroni L, Lawrence C, Edouard A, Costa Y, Samii K, Brun-Buisson C. Prospective, 6 randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter 7 colonization and infection in intensive care unit patients. Crit Care Med 1996; 24(11): 1818-1823. 8

3. Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine 9 solution for vascular catheter-site care: a meta-analysis. Ann Intern Med 2002; 136: 792 801. 10

4. Prager RL, Silva J. Colonization of central venous catheters. South Med J 1984; 77: 458-461. 11 5. Maki DG, Band JD. A comparative study of polyantibiotic and iodophor ointment in prevention of 12

vascular catheter-related infection. Am J Med 1981; 70: 739-744. 13 14 15 4.10 Catheter Replacement Strategies 16 17 When and how catheters are replaced can influence the risk of infection 18 A catheter replacement strategy is composed of two elements; the frequency and the 19 method of catheter replacement. 20 21 Frequency 22 The risk of phlebitis and catheter colonisation, both associated with CR-infection, 23 could be reduced by catheter replacement and site rotation every 72-96 hours.1 24 However, decisions regarding the frequency of CVC replacement are more 25 complicated. The evidence showed duration of catheterisation to be a risk factor for 26 infection and advocates routine replacement of CVC at specified intervals as a 27 measure to reduce infection.2-5 Other studies, however, suggested that the daily risk 28 of infection remains constant and showed that routine replacement of CVC, without a 29 clinical indication, does not reduce the rate of catheter colonisation or the rate of CR-30 BSI.6-7 Conclusions from a systematic review agree that exchanging catheters by any 31 method every three days was not beneficial in reducing infections, compared with 32 catheter replacement on an as-needed basis. 8 33 34 Methods 35 Two methods are used for replacing CVC; placing a new catheter over a guide wire 36 at the existing site, or percutaneously inserting a new catheter at another site. Guide 37 wire insertion has been the accepted technique for replacing a malfunctioning 38 catheter (or exchanging a pulmonary artery catheter for a CVC when invasive 39 monitoring was no longer needed) as they are associated with less discomfort and a 40 significantly lower rate of mechanical complications than those percutaneously 41 inserted at a new site. Studies of the risks for infection associated with guide wire 42 insertions examined by HICPAC yielded conflicting results. One prospective study 43 showed a significantly higher rate of CR-BSI associated with catheters replaced over 44 a guide wire compared with catheters inserted percutaneously.6 However, three 45 prospective studies (two randomised) showed no significant difference in infection 46 rates between catheters inserted percutaneously and those inserted over a guide 47 wire.7,9-10 Because these studies suggest that the insertion of the new catheter at a 48

100

new site does not alter the rate of infectious complications per day but does increase 1 the incidence of mechanical complications, guide wire exchange is recommended. 2 Most studies examined by HICPAC concluded that, in cases where the catheter 3 being removed is known to be infected, guidewire exchange is contraindicated.7,9-12 4 5 A SR concluded that, compared with new site replacement, guidewire exchange was 6 associated with a trend toward a higher rate of subsequent catheter colonisation, 7 regardless of whether patients had a suspected infection at the time of replacement. 8 Guidewire exchange was also associated with trends toward a higher rate of catheter 9 exit-site infection and CR-BSI. However, guidewire exchange was also associated 10 with fewer mechanical complications relative to new-site replacement. 8 11 12 Methods are available and techniques have been described which allow a diagnosis 13 of CR-BSI to be made without the need for catheter removal.13 Such approaches 14 could be used prior to the replacement of a new catheter over a guide wire in order to 15 reduce the subsequent risk of CR-infection.13,14 16 17 Neither we nor HICPAC guidleine developers identified and additional evidence for 18 these recommendations whilst updating our systematic reviews. 19 20 Peripheral vascular devices 21 We identified one RCT comparing a routine three-day re-siting of PVC compared with 22 a clinically indicated re-siting. Intravascular device related (IVD) complication rates 23 were 68 per 1,000 IVD days (clinically indicated) and 66 per 1,000 IVD days (routine 24 replacement) (p= 0.86; HR 1.03; 95% CI, 0.74-1.43). Re-siting a device on clinical 25 indication would allow one in two patients to have a single cannula per course of 26 intravenous treatment, as opposed to one in five patients managed with routine re-27 siting; overall complication rates appear similar. Clinically indicated re-siting would 28 achieve savings in equipment, staff time and patient discomfort.15 29 30 A recent update of a Cochrane Review published in 2010 found no evidence to 31 support changing catheters every 72 to 96 hours. Consequently, healthcare 32 organisations may consider changing to a policy whereby catheters are changed only 33 if clinically indicated. This would provide significant cost savings and would spare 34 patients the unnecessary pain of routine re-sites in the absence of clinical indications. 35 To minimise peripheral catheter-related complications, the insertion site should be 36 inspected at each shift change and the catheter removed if signs of inflammation, 37 infiltration, or blockage are present.16 38 39 40 IVAD 27

Do not routinely replace central venous access devices as a method to prevent catheter-related infection. [Revised wording]

Class A

IVAD 28

Guide wire assisted catheter exchange to replace a malfunctioning catheter, or to exchange an existing catheter should only be used when there is no evidence of infection at the catheter site or a diagnosed catheter-related bloodstream infection. [Revised wording]

Class A

IVAD 29

Do not use guide wire assisted catheter exchange for patients with known or suspected catheter-related bloodstream infection. If continued vascular access is

Class A

101

required, remove the implicated catheter, and replace it with another catheter at a different insertion site. [Revised wording]

IVAD 30

Peripheral vascular catheters should be removed as soon as they are no longer required or when complications occur. [New recommendation]

Class D/ GPP

IVAD 31 The insertion site should be inspected at a minimum on every shift a Visual Infusion Phlebitis score recorded. The catheter should be removed if there are signs of inflammation, infiltration or blockage. [New recommendation]

Class D/ GPP

IVAD 32 Peripheral vascular catheters should be re-sited when clinically indicated and not routinely at 72-96 hours, unless device specific recommendations from the manufacturer indicate otherwise. [New recommendation]

Class B

1 References 2 1.

Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-Related Infections, Clin Infect Dis. 2011 May;52(9):e162-193.

2. Richet H, Hubert B, Nitenberg G, et al. Prospective multicenter study of vascular catheter related complications and risk factors for positive central catheter cultures in intensive care unit patients. J Clin Microbio 1990;28:2520-2525.

3. Gil RT, Kruse JA, Thill-Baharozian MC, Carolson RW. Triple- vs single-lumen central venous catheters. A prospective study in a critically ill population. Arch Intern Med 1989;149:1139-1143.

4. Miller JJ, Venus B, Mathru M. Comparison of the sterility of long-term central venous catheterisation using single-lumen, triple-lumen, and pulmonary artery catheters. Crit Care Med 1984;12:634-637.

5. Ullman RF, Gurevich I, Schoch PE, Cunha BA. Colonization and bacteremia related to duration of triple-lumen intravascular catheter placement. American J Infect Control 1990;18:201-207.

6. Cobb DK, High KP, Sawyer RG, et al. A controlled trial of scheduled replacement of central venous and pulmonary artery catheters. N Engl J Med 1992;237:1062-1068.

7. Michel LA, Bradpiece HA, Randour P, Pouthier F. Safety of central venous catheter change over a guide wire for suspected catheter-related sepsis: a prospective randomised trial. Intern Surg1988;73:180-186.

8. Cook D, Randolph A, Kemerman P, Cupido C, King D, Soukup C, Brun-Buisson C. Central venous catheter replacement strategies: A systematic review of the literature. Crit Care Med 1997;25(8):1417-1424.

9. Armstrong CW, Mayhall CG, Miller KB, et al. Prospective study of catheter replacement and other risk factors for infection of hyperalimentation catheters. J Infect Dis 1986; 154: 808-816.

10. Synder RH, Archer FJ, Endy T, et al. Catheter infection. A comparison of two catheter maintenance techniques. Ann Surg 1988;208:651-653.

11. Pettigrew RA, Lang SDR, Haydock DA, Parry BR, Bremner DA, Hill GL. Catheter-related sepsis in patients on intravenous nutrition: a prospective study of quantitative catheter cultures and guide wire changes for suspected sepsis. Brit J Surg 1985;72:52-55.

12. Newsome HH Jr, Armstrong CW, Mayhall CG, et al. Mechanical complications from insertion of subclavian venous feeding catheters: comparison of de novo percutaneous venipuncture to change of catheter over guide wire. J Parent Enteral Nutr 1984;8:560-562.

13. Farr BM. Accuracy and cost-effectiveness of new tests for diagnosis of catheter-related bloodstream infections. Lancet 1999;354:1487-8.

14. Siegman-Igra Y, Anglim AM, Shapiro D, Adal KA, Strain B, Farr MB. Diagnosis of vascular catheter-related bloodstream infection: a meta-analysis. J Clin Microbio 1997;35:928-36.

15. Rickard CM, McCann D, Munnings J, McGrail MR. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial. BMC Med. 2010; 8: 53.

102

16. Webster J, Osborne S, RickardCM, NewK. Clinically-indicated replacement versus routine replacement of peripheral venous catheters. Cochrane Database Syst Rev 2013; Issue 4.

1 4.11 General Principles for Catheter Management 2 3 Aseptic technique is important when accessing the system 4 Evidence demonstrating that contamination of the catheter hub contributes to 5 intraluminal microbial colonisation of catheters, particularly long-term catheters, was 6 considered by HICPAC.1-7 Catheter hubs are accessed more frequently when 7 catheterisation is prolonged and this increases the risk of a CR-BSI originating from a 8 colonised catheter hub rather than the insertion site.7 Evidence from a prospective 9 cohort study suggested that frequent catheter hub manipulation increases the risk for 10 microbial contamination.8 Additional studies concurred and recommended that hubs 11 and sampling ports should be disinfected using either povidone-iodine or 12 chlorhexidine before they are accessed,9,10,11 13 14 A randomized prospective clinical trial investigated the use of needleless connectors 15 or standard caps attached to CVC luer connections Results suggested that the use of 16 needleless connectors may reduce the microbial contamination rate of CVC luers 17 compared with standard caps. Furthermore, disinfection of needleless connectors 18 with either chlorhexidine/alcohol or povidone iodine significantly reduced external 19 microbial contamination. Both these strategies may reduce the risk of catheter-20 related infections acquired via the intraluminal route. 12 21 22 We found no evidence comparing the efficacy of different methods of 23 decontaminating ports and hubs prior to access. Expert opinion, based on 24 consensus and evidence from studies of skin decontamination prior to insertion and 25 during dressing changes, suggests that injection ports or catheter hubs should be 26 decontaminated before and after accessing the system using CHG in 70% alcohol. 27 Although most intravascular catheters and catheter hub materials are now chemically 28 compatible with alcohol or iodine, some may be incompatible and therefore the 29

recommendations should be followed.13 30 31 32 IVAD33

Use 2% chlorhexidine gluconate in 70% isopropyl alcohol (or alcoholic povidone iodine for patients with a sensitivity to chlorhexidine) to decontaminate the access port or catheter hub and allow to dry before and after accessing the system unless device specific recommendations from the manufacturer indicate otherwise. [Reworded recommendation]

Class D/ GPP

33 References 34 1. deCicco M, Chiaradia V, Veronesi A, et al. Source and route of microbial colonization of parenteral

nutrition catheters. Lancet 1982;2:1258-1261. 2. Capell S, Linares J, Sitges-Serra A. Catheter sepsis due to coagulase-negative staphylococci in

patients on total parenteral nutrition. European Journal of Clinical Microbio Infect Dis1986:5:40-42. 3. Salzman MB, Isenberg HD, Shapiro JF, Lipsitz PJ, Rubin LG. A prospective study of the catheter

hub as the portal of entry for microorganisms causing catheter-related sepsis in neonates. J Infect Dis 1993;167:487-490.

4. Peters G, Locci R, Pulverer G. Adherence and growth of coagulase-negative staphylococci on surfaces of intravenous catheters. J Infect Dis 1982;146:479-482.

5. Linares J, Sitges-Serra A, Garau J, Perez JL, Martin R. Pathogenesis of catheter sepsis: a prospective study with quantitative and semiquantitative cultures of catheter hub and segments. J

103

Clin Microbio1985;21:357-360. 6. Sitges-Serra A, Linares J, Perez JL, Jaurrieta E, Lorente L. A randomized trial on the effect of

tubing changes on hub contamination and catheter sepsis during parenteral nutrition. JPEN 1985;9:322-325.

7. Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis 1993;168:400-407.

8. Weist K, Sperber A, Dietz E, Ruden H. Contamination of stopcocks mounted in administration sets for central venous catheters with replacement at 24 hrs versus 72 hrs: a prospective cohort study. Infect Control Hosp Epidemio 1997;18(5 Pt 2):24.

9. Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of central venous catheter related bloodstream infection by use of an antiseptic-impregnated catheter. A randomized controlled trial. Ann Intern Med 1997;127:257-66.

10. Salzman MB, Isenberg HD, Rubin LG. Use of disinfectants to reduce microbial contamination of hubs of vascular catheters. J Clin Microbio 1993;31:475-479.

11. Rushman KL, Fulton JS. Effectiveness of disinfectant techniques on intravenous tubing latex injection ports. J Intraven Nurs1993;16:304-308.

12. Casey AL, Worthington T, Lambert PA, Quinn D, Faroqui MH, Elliott TSJ. A randomized, prospective clinical trial to assess the potential infection risk associated with the PosiFlow® needleless connector. J Hosp Infect 2003;54:288-93

13. NICE community 1 2 Inline filters do not help prevent infections 3 In-line filters are used to reduce the incidence of infusion-related phlebitis, however, 4 HICPAC identified no good quality evidence to support the efficacy of in-line filters in 5 preventing infections associated with intravascular catheters and infusion systems. 6 Guideline developers concluded that filtration of medications or infusates in the 7 pharmacy is a more practical and efficient method for removing the majority of 8 particulates. In addition, in-line filters may become blocked, particularly when used 9 with certain solutions, e.g., dextran, lipids, mannitol, resulting in increased line 10 manipulations and decreased availability of administered drugs.1 There may a be a 11 role for the use of in-line filtration of parenteral nutrition solutions for reasons other 12 than the prevention of infection but these are beyond the scope of these guidelines. 13 IVAD34

In-line filters should not be used routinely for infection prevention purposes. [No change]

Class D/ GPP

14 Reference 15 1. 16

Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 17 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-18 Related Infections, Clin Infect Dis. 2011 May;52(9):e162-93. 19

20

Using antimicrobial solutions to prevent infection 21 The procedure of flushing and then leaving the lumen of the CVC filled with an 22

23 measure to prevent CR-BSI in specific circumstances, such as when treating a 24 patient with a long-term cuffed or tunnelled catheter or port who has a history of 25 multiple CR-BSI despite optimal maximal adherence to aseptic technique. Evidence 26 reviewed by HICPAC 1 demonstrated the effectiveness of this type of prophylaxis. 27 However, the majority of the studies were conducted in haemodialysis patients and 28 therefore outside the scope of this guideline. 29 30 We identified a systematic review of randomised controlled trials published in 2012 31 that concluded that the scientific evidence for the effectiveness of the routine use of 32

104

antibiotic-based lock solutions is weak,2 thus supporting the HICPAC evidence. In 1 addition, there is concern that the use of such solutions could lead to an increase in 2 antimicrobial resistant microorganisms.1 3 4 An additional placebo - RCT of daily ethanol locks to prevent CR-BSI in patients with 5 tunneled catheters3 found the reduction in the incidence of endoluminal CR-BSI using 6 preventive ethanol locks was non-significant, although the low incidence of 7 endoluminal CR-BSI precludes definite conclusions and the low incidence of CR-BSI 8 in the placebo arm meant the study was underpowered in retrospect. Significantly 9 more patients treated with ethanol locks discontinued their prophylactic treatment 10 due to non-severe, ethanol related adverse effects. 11 12 13 IVAD35 Antibiotic lock solutions should not be used routinely to

prevent catheter-related bloodstream infections. Class D/ GPP

[No change] 14 15 References 16 1. 17

Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 18 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-19 Related Infections, Clin Infect Dis. 2011 May;52(9):e162-93. 20

2. Snaterse M, Ruger W, Scholte op Reimer WJ, Lucas C. Antibiotic-based catheter lock solutions for 21 prevention of catheter-related bloodstream infection: a systematic review of randomised controlled 22 trials. J Hosp Infect. 2010; 75(1): 1-11 23

3. Slobbe L, Doordurjn JK, Lugtenburg PJ, el Barzouhi A, Boersma E et al Prevention of catheter-24 related bacteraemia with a daily ethanol lock in patients with tunnelled catheters: a randomised, 25 placebo-controlled trial. PLos ONE. 2010; 5(5): e10840 26

27 28 Systemic antibiotic prophylaxis does not prevent CR-BSI 29 HICPAC identified no studies that demonstrated that oral or parenteral antibacterial 30 or antifungal drugs reduced the incidence of CR-BSI among adults. However, among 31 low birth weight infants, two studies on vancomycin prophylaxis demonstrated a 32 reduction in CR-BSI but no reduction in mortality. Since the prophylactic use of 33 vancomycin is an independent risk factor for the acquisition of vancomycin-resistant 34 Enterococcus (VRE), it is likely that the risk of acquiring VRE outweighs the benefit of 35 using prophylactic vancomycin.1 36 Long-term tunnelled CVC are frequently used for patients with cancer who require 37 intravenous treatments. A Cochrane Review published in 2003 concluded that 38 prophylactic antibiotics or catheter flushing with vancomycin and heparin may be of 39 benefit in reducing the risk of catheter-related infections in these high risk cancer 40 patients.2 However, this practice should not be used routinely in order to minimise the 41 development of antimicrobial resistance.3 42 43 IVAD36

Do not routinely administer intranasal or systemic antimicrobials before insertion or during the use of an intravascular device to prevent catheter colonisation or bloodstream infection. [Revised wording]

Class A

References 44 1. Centers for Disease Control and Prevention. Guidelines for the Prevention of intravascular-catheter-45

related Infections. Morbidity and Mortality Weekly Report 2002;51(No.RR-10):1-29.Available from 46 http://www.cdc.gov/mmwr/PDF/rr/rr5110.pdf 47

105

2. Van de Wetering MD, van Woensel JBM. Prophylactic antibiotics for preventing early central venous 1 catheter Gram positive infections in oncology patients (Review), The Cochrane Database of 2 Systematic Reviews 2003; Issue 1:1-16. 3

3. Garland J, Heard, SO, Lipsett PA, Masur H, 4 Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 5 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-6 Related Infections, Clin Infect Dis. 2011 May;52(9):e162-93. 7

8 A dedicated catheter lumen is needed for parenteral nutrition 9 A prospective epidemiologic study examining the risk for CR-BSI in patients receiving 10 TPN reviewed by HICPAC concluded that either using a single lumen catheter or a 11 dedicated port in a multilumen catheter for TPN would reduce the risk of infection.1 12 We identified no new evidence in our search for evidence. 13 14 IVAD37 A single-lumen catheter should be used to administer

parenteral nutrition. If a multilumen catheter is used, one port must be exclusively dedicated for hyperalimentation and all lumens must be handled with the same meticulous attention to aseptic technique. [Revised wording].

Class D/ GPP

15 16 References 17 1. Centers for Disease Control and Prevention. Guidelines for the Prevention of intravascular-catheter-18

related Infections. Morbidity and Mortality Weekly Report 2002;51(No.RR-10):1-29.Available from 19 http://www.cdc.gov/mmwr/PDF/rr/rr5110.pdf 20

21 22 Maintaining device patency and preventing catheter thrombosis may help 23 prevent infections 24 The placement of a CVC or pulmonary artery catheter leads to thrombus formation 25 within a short period of insertion providing a focus for bacterial growth.1 Catheters 26 manufactured from silicone or polyethylene, and placed in the subclavian vein are 27 less often associated with thrombus formation.2 Between 35% and 65% of patients 28 with long term CVC develop a thrombosis of the large vessels and patients are 29 treated with prophylactic heparin to prevent the formation of both deep-vein 30 thrombosis and catheter thrombus.3-9 31 32 The use of anticoagulants 33 Heparin may be administered through several different routes. An early meta-34 analysis of randomised controlled trials compared the effectiveness of heparin 35 administration via an infusion, subcutaneously or intermittent flush for the prevention 36 of thrombus formation and CR-BSI in patients with short-term CVC.10 Prophylactic 37 heparin infusion was associated with a decrease in catheter thrombus formation, 38 deep vein thrombosis, catheter colonisation and a trend towards reductions in CR-39 BSI but was not statistically significant. HICPAC identified an additional prospective 40 randomised trial, which demonstrated a significant decrease in the rate of CR-BSI in 41 patients with non-tunnelled CVC who received continuous heparin infusion.11 Heparin 42 bonded catheters have also be shown to reduce the risk of both thrombus formation 43 and CR-BSI.12-15 44 45 We identified one SR of heparin bonded CVC in children.16 The reviewers identified 46 two RCT of 287 children aged one day to 16 years to receive either a heparin-47 bonded (HB) catheter or a standard catheter. There was no significant difference in 48 the median duration of catheter patency in the two groups, seven days in the 49

106

heparin-bonded catheter group and six days in the standard catheter group. Authors 1 also reported a trend towards a reduction in the risk of catheter-related thrombosis 2 and catheter occlusion in the heparin bonded group. The risk of catheter colonisation 3 and catheter-related infection were significantly reduced in the treatment group, with 4 a delay to infection in the heparin-bonded catheter group. However the reviewers 5 considered the need for further studies to confirm the efficacy the heparin-bonded 6 catheters. 7 8 The use of warfarin has also been shown to reduce the risk of catheter-related 9 thrombosis in some patient groups but not in others and is generally not associated 10 with a reduction in infection related complications.17-23 11 12 Heparin versus Normal Saline Intermittent Flushes 13 Systemic heparin as either an infusion or flush has a number of side effects that 14 contraindicate its routine use for maintaining the patency of CVC and prevent 15 thrombus formation, these include thrombocytopenia, allergic reactions and 16 bleeding.24 Sodium chloride injection (0.9%) is an alternative to the use of heparin 17 flush. 18 19 Three SR and meta-analysis of RCT evaluating the effect of heparin on duration of 20 catheter patency and on prevention of complications associated with the use of 21 peripheral venous and arterial catheters concluded that heparin at doses of 10 U/ml 22 for intermittent flushing is no more beneficial than flushing with normal saline alone.25-23 27 However, manufacturers of implanted ports or opened-ended catheter lumens may 24 recommend heparin flushes for maintaining CVC that are infrequently accessed. 25 26 We identified one SR (CVC11) and two RCT comparing heparin vs 0.9% sodium 27 chloride to maintain the patency of CVC (CVC12) and PVC (PVC1) respectively.28-30 28 A SR of heparin flushing and other interventions to maintain patency of central 29 venous catheters concluded that the evidence base for heparin flushing and other 30 interventions to prevent catheter occlusion is limited and published studies are of low 31 quality. The reviewers concluded that there is no direct evidence of the effectiveness 32 of heparin flushes to prevent catheter-related bloodstream infection or other central 33 line complications. 34 35 In a single centre RCT of newly placed multi-lumen CVC in patients in MICU and 36 surgical/burn/ trauma ICU, 0.9% sodium chloride and heparin flush solutions were 37 found to have similar rates of lumen non-patency. Given potential safety concerns 38 with the use of heparin, 0.9% sodium chloride may be the preferred flushing solution 39 for short-term use central venous catheter maintenance. Secondary outcomes for 40 CRBSI were non-significant between groups 41 42 In a single centre cluster RCT of 214 medical patients found that twice-daily heparin 43 (100 U/mL) flushes for maintenance of peripheral venous catheters was more 44 effective than saline solution. The number of catheter-related phlebitis/ occlusions 45 and the number of catheters per patient were reduced, with potential advantages to 46 both patients and the health system, no infection outcomes were measured.47

107

IVAD38

Do not use systemic anticoagulants routinely to prevent catheter-related bloodstream infection. [Revised wording]

Class D/ GPP

IVAD39

Use sterile 0.9 percent sodium chloride for injection to flush and lock catheter lumens that are in frequent use. [Revised wording]

Class A

1 2 References 3 1. Hoar PF, Wilson RM, Managano DT, et al. Heparin bonding reduces thrombogenicity of pulmonary-4

artery catheters. New England Journal of Medicine 1981;305:993-95. 5 2. Ge X, Cavallazzi R, Li C, Pan SM, Wang YW, Wang FL. Central venous access sites for the 6

prevention of venousthrombosis, stenosis and infection. Cochrane Database of Systematic Reviews 7 2012, Issue 3. Art. No.: CD004084. . 8

3. Raad ML II, Khalil S-AM, Costerton JW, et al. The relationship between the thrombotic and infectious 9 complications of central venous catheters. Journal of the American Medical Association 10 1994;271:1014-1016. 11

4. Chastre J., Comud F, Bouchama A, et al. Thrombosis as a complication of pulmonary-artery 12 catheterisation within the internal jugular vein. New England Journal of Medicine 1982;306:278-281. 13

5. Valerio D, Hussey JK, Smith FW. Central venous thrombosis associated with intravenous feeding: a 14 prospective study. Journal of Parenteral and Enteral Nutrition 1981;5:240-242. 15

6. Andrew M, Marzinotto V, Pencharz P, et al. A cross-sectional study of catheter-related thrombosis in 16 children receiving total parenteral nutrition at home. Journal of Pediatrics 1995;126:358-363. 17

7. Krafte-Jacobs B, Sivit CJ, Mejia R, et al. Catheter-related thrombosis in critically ill children: 18 comparison of catheters with and without heparin bonding. Journal of Pediatrics 1995;126:50-54. 19

8. Talbott GA, Winters WD, Bratton SL, et al. A prospective study of femoral catheter-related 20 thrombosis in children. Archives of Pediatric and Adolescent Medicine 1995;149:288-289. 21

9. Centers for Disease Control and Prevention. Guidelines for the Prevention of intravascular-catheter-22 related Infections. Morbidity and Mortality Weekly Report 2002;51(No.RR-10):1-29.Available from 23 http://www.cdc.gov/mmwr/PDF/rr/rr5110.pdf 24

10. Randolph AG, Cook DJ, Gonzales CA, Andrew M. Benefit of Heparin in Central Venous and 25 Pulmonary Artery Catheters: A Meta-analysis of Randomized Controlled Trials. Chest January 26 1998;113(1):165-171. 27

11. Bern MM, Lokich JJ, Wallach SR, Bothe A Jr, Benotti PN, Arkin CF, et al. Very low doses of warfarin 28 can prevent thrombosis in central venous catheters. A randomized prospective trial. Annals of 29 Internal Medicine 1990;112:423-428. 30

12. Abdelkefi A, Torjman L, Ladeb S, et al. Randomized trial of prevention of catheter-related 31 bloodstream infection by continuous infusion of low-dose unfractionated heparin in patients with 32 hematologic and oncologic disease. J Clin Oncol 2005; 23:7864 7870. 33

13. Pierce CM, Wade A, Mok Q. Heparin-bonded central venous lines reduce thrombotic and infective 34 complications in critically ill children. Intensive Care Med 2000; 26:967 972. 35

14. Appelgren P, Ransjo U, Bindslev L, Espersen F, Larm O. Surface heparinization of central venous 36 catheters reduces microbial colonization in vitro and in vivo: results from a prospective, randomized 37 trial. Crit Care Med 1996; 24:1482 1489. 38

15. Abdelkefi A, Achour W, Ben Othman T, et al. Use of heparin-coated central venous lines to prevent 39 catheter-related bloodstream infection. J Support Oncol 2007; 5:273 278. 40

16. Shah PS, Shah N. Heparin-bonded catheters for prolonging the patency of central venous catheters 41 in children. Cochrane Database Syst Rev 2007, Issue 4. Art. No.: CD005983. DOI: 42 10.1002/14651858.CD005983.pub2. 43

17. Boraks P, Seale J, Price J, et al. Prevention of central venous catheter associated thrombosis using 44 minidose warfarin in patients with haematological malignancies. Br J Haematol 1998; 101:483 486. 45

18. Bern MM, Lokich JJ, Wallach SR, et al. Very low doses of warfarin can prevent thrombosis in central 46 venous catheters. A randomized prospective trial. Ann Intern Med 1990; 112:423 428. 47

19. Akl EA, Karmath G, Yosuico VED, Kim SY, Barba M, Sperati F, Cook D, Schu¨nemann H. 48 Anticoagulation for thrombosis prophylaxis in cancer patients with central venous catheters. 49 Cochrane Database of Systematic Reviews 2007; Issue 3. Art. No.: CD006468. DOI: 10.1002/ 50 14651858.CD006468.pub2. 51

20. Akl EA, Muti P, Schunemann HJ. Anticoagulation in patients with cancer: an overview of reviews. Pol 52 Arch Med Wewn 2008; 118:183 193. 53

21. Klerk CP, Smorenburg SM, Buller HR. Thrombosis prophylaxis in patient populations with a central 54 venous catheter: a systematic review. Arch Intern Med 2003; 163:1913 1921. 55

108

22. Van Donk P, Rickard CM, McGrail MR, Doolan G. Routine replacement versus clinical monitoring of 1 peripheral intravenous catheters in a regional hospital in the home program: a randomized controlled 2 trial. Infect Control Hosp Epidemiol 2009; 30:915 917. 3

23. Webster J, Clarke S, Paterson D, et al. Routine care of peripheral intravenous catheters versus 4 clinically indicated replacement: randomised controlled trial. BMJ 2008; 337:a339. 5

24. Passannante A, Macik BG. Case report: the heparin flush syndrome: a cause of iatrogenic 6 hemorrhage. American Journal of Medical Science July 1998;296:71-73. 7

25. Randolph AG, Cook DJ, Gonzales CA, Andrew M. Benefit of heparin in peripheral venous and 8 arterial catheters: systematic review and meta-analysis of randomised controlled trials. British 9 Medical Journal 1998;316:969-975. 10

26. Goode CJ, Titler M, Rakel B, Ones DS, Kleiber C, Small S, et al. A meta-analysis of effects of 11 heparin flush and saline flush: quality and cost implications. Nursing Research 1991;40:324-30. 12

27. Peterson FY, Kirchoff KT. Analysis of the research about heparinized versus nonheparinized 13 intravascular lines. Heart and Lung 1991;20:631-640 14

28. Mitchell MD, Anderson DBJ , Williams K, Umscheid CA Heparin flushing and other interventions to 15 maintain patency of central venous catheters: a systematic review. Journal of Advanced Nursing. 16 2009;65(10):2007 2021 17

29. Schallom ME, Prentice D, Sona C, Micek S, Srupky LP. Hepariin or 0.9% sodium chloride to 18 maintain central venous catheter patency: A randomized trial. Crit Care Med 2012; 40: 1820 1826 19

30. Bertolino G, Pitassi A, Tinelli C Staniiscia A, Guglielmana B, Scudeller L, Balduini C. Intermittent 20 flushing with heparin versus saline for maintenance of peripheral intravenous catheters in a medical 21 department: a pragmatic cluster-randomized controlled study. Worldviews Evid Based Nurs. 22 2012;9(4):221-226. 23

24 25 Safer sharps devices require vigilance 26 Needle-free infusion systems and connection devices have been widely introduced to 27 reduce the incidence of sharp injuries and minimise the risk of transmission of 28 bloodborne pathogens to healthcare workers.1 There is limited evidence that 29 needleless devices or valves reduce the risk of catheter colonisation when compared 30 to standard devices.2 In addition, the design features of some of these devices pose 31 a potential risk for contamination and have been associated with reports of an 32 increase in bloodstream infection rates.3-6 33 34 IVAD40

The introduction of new intravascular devices or components should be monitored for an increase in the occurrence of device-associated infection. If an increase in infection rates is suspected, this should be reported to the Medicines and Healthcare Products Regulatory Agency. [No change]

Class D/ GPP

IVAD41

When safer sharps devices are used, healthcare workers should ensure that all components of the system are compatible and secured to minimise leaks

recommendations for changing the needle-free components should be followed. [Revised wording]

Class D/ GPP

IVAD42

When needle-free devices are used, the risk of contamination should be minimised by decontaminating the access port before and after use with a single use application of 2% chlorhexidine gluconate in 70% isopropyl alcohol (or alcoholic povidone iodine for patients with a sensitivity to chlorhexidine) unless device specific recommendations from the manufacturer indicate otherwise.

Class D/ GPP

109

[Revised wording] 1 References 2 1. Centers for Disease Control and Prevention. Evaluation of safety devices for preventing 3

percutaneous injuries among health care workers during phlebotomy procedures- Minneapolis-St 4 Paul, New York City, and San Francisco, 1993-1995. Morbidity and Mortality Weekly 1997;46(2):21-5 25. 6

2. 7 Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 8 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-9 Related Infections, Clin Infect Dis. 2011 May;52(9):e162-93. 10

3. Rupp ME, Sholtz LA, Jourdan DR, et al. Outbreak of bloodstream infection temporally associated 11 with the use of an intravascular needleless valve. Clin Infect Dis 2007; 44:1408 14. 12

4. Salgado CD, Chinnes L, Paczesny TH, Cantey JR. Increased rate of catheter-related bloodstream 13 infection associated with use of a needleless mechanical valve device at a long-term acute care 14 hospital. Infect Control Hosp Epidemiol 2007; 28:684 8. 15

5. Maragakis LL, Bradley KL, Song X, et al. Increased catheter-related bloodstream infection rates 16 after the introduction of a new mechanical valve intravenous access port. Infect Control Hosp 17 Epidemiol 2006; 27:67 70. 18

6. Field K, McFarlane C, Cheng AC, et al. Incidence of catheter-related bloodstream infection among 19 patients with a needleless, mechanical valve-based intravenous connector in an Australian 20 hematology-oncology unit. Infect Control Hosp Epidemiol 2007; 28:610 3. 21

22 23 Change intravenous administration sets appropriately 24 HICPAC reviewed three well-controlled studies on the optimal interval for the routine 25 replacement of intravenous (IV) solution administration sets.1 A SR of 13 RCT with 26 4783 patients concluded that there is no evidence that changing intravenous 27 administration sets more often than every 96 hours reduces the incidence of 28 bloodstream infection. The reviewers were unable to conclude if changing 29 administration sets less often than every 96 hours affects the incidence of infection 30 from the studies. There were no differences between participants with central versus 31 peripheral catheters; nor between participants who did and did not receive parenteral 32 nutrition, or between children and adults. Administration sets that do not contain 33 lipids, blood or blood products may be left in place for intervals of up to 96 hours 34 without increasing the incidence of infection. There was no evidence to suggest that 35 administration sets, which contain lipids should not be changed every 24 hours as 36 currently recommended.2 37 38 39 IVAD43

Administration sets in continuous use do not need to be replaced more frequently every 96 hour unless device specific recommendations from the manufacturer indicate otherwise or they become disconnected or an intravascular access device is replaced. [Revised recommendation]

Class A

40 IVAD44

Administration sets for blood and blood components should be changed when the transfusion episode is complete or every 12 hours (whichever is sooner), or

[No change]

Class D/ GPP

110

IVAD45

Administration sets used for total parenteral nutrition (fat emulsion) infusions should be changed every 24 hours unless device specific recommendations from the manufacturer indicate otherwise. [Revised recommendation]

Class D/ GPP

1 2 References 3

1. 4 Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint S, and the Healthcare Infection 5 Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-6 Related Infections, Clin Infect Dis. 2011 May;52(9):e162-93. 7

2. 8 intravenous administration set replacement. Cochrane Database of Systematic Reviews 2005; 9 Issue 4. Art. No.: CD003588. DOI: 10.1002/14651858.CD003588.pub2. 10

11 System interventions to reduce catheter-related infection 12

13 delivering high quality health care. In 2005 the Department of Health issued a series 14 of high impact interventions (HII) that were derived from national and international 15 evidence-based guidelines for the prevention of healthcare associated infection and 16 base on experience from the Institute of Healthcare Improvement 100,000 Lives 17 Campaign focused on reducing patient harm.1 The HII focused on increasing the 18 reliability of care and ensuring that recommendations were implemented every time 19 for every patient. The intervention for the prevention of infection associated with the 20 use of intravascular devices included six key interventions often referred to as a 21

22 included: 23

aseptic insertion of an appropriate device; 24 correct siting of the device; 25 effective cutaneous antisepsis; 26

27 and for the continuing care or the device: 28 hand decontamination and asepsis for any contact with the device; 29 daily observation of the insertion site; and 30 clean, intact dressing. 31

32 There have been a small number of well designed studies2,3 that describe the use of 33

-BSI, which have stimulated individual 34 observational and quality improvement (QI) reports of the results of using key 35 evidence based practices in preventing CR-BSI. The most prominent of these was a 36 study conducted in the ICU setting of 108 hospitals in the USA which was then 37 adopted by other countries including the UK.4 Authors reported the success of five 38 evidence based practices combined with system and organisational support, which 39 resulted in a 66% decrease in CR-BSI 18 months after the inception of the 40 programme [0.62 (95% confidence interval [CI], 0.47 to 0.81)] to [0.34 (95% CI, 0.23 41 to 0.50)] and sustained reductions thereafter.5 The intervention comprised: hand 42 hygiene using ABHR; maximum sterile barrier precautions for insertion; cutaneous 43 antisepsis of the insertion site with 2% CHG; avoiding the femoral site, and removing 44 CVC as soon as they were no longer clinically indicated. In addition, system 45

46 equipment needed in a cart for ease of access; the use of a checklist; authorising 47 staff to halt procedures if best practice was not being followed; daily rounds to ensure 48 the timely removal of CVC; feedback of CR-BSI cases to clinical staff and 49 organisational support to purchase essential equipment and solutions prior to the 50 start of the study. 51

111

1 Audit and feedback are an essential component of any quality improvement 2

3 maintain vigilance and sustain improvement. The use of dashboards and statistical 4 process control charts alerts clinicians to variability outside control limits and prompts 5 scrutiny of practice and organisational systems and remedial action to be taken. 6 7

8 CR-BSI.7-9 None were included in the systematic review as they failed to meet study 9 quality criteria. The features of any QI initiative need to be tailored to the local 10 conditions and may include some or all of the following: 11

Hand hygiene; aseptic insertion using maximum sterile barrier precautions 12 CVC) aseptic technique (PVC); cutaneous antisepsis using 2% CHG in 13 alcohol unless contraindicated; appropriate siting of the CVC or PVC; and 14 prompt removal when no longer indicated; 15

Audit and feedback; 16 Education and training 17 Accessibility of equipment and appropriate system changes developed with 18

clinical staff to make best practice the norm. 19 20 IVAD46 Use quality improvement systems to support the

appropriate use and management of intravascular access devices (CVC and PVC) and ensure their timely removal. These may include:

Protocols for device insertion and maintenance; Reminders to review the continuing use or

prompt the removal of intravascular devices; Audit and feedback of compliance with practice

guidelines; Continuing professional education.

[New recommendation]

Class C/ GPP

21 22 References 23 1. Department of Health. Saving Lives: a delivery programme to reduce Healthcare Associated 24

Infection including MRSA. London: Department of Health; 2005. 25 2. Eggimann P, Harbarth S, Constantin MN, Touveneau S, Chevrolet JC, Pittet D. Impact of a 26

prevention strategy targeted at vascular-access care on incidence of infections acquired in intensive 27 care. Lancet 2000; 355:1864 1868. 28

3. Berenholtz SM, Pronovost PJ, Lipsett PA et al. Eliminating catheter related bloodstream infections 29 in the intensive care unit. Crit Care Med 2004; 32: 2014-2020. 30

4. Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove C, Sexton B, Hyzy R, 31 Welsh R, Roth G, Bander J, Kepros J, Goeschel C, An intervention to decrease catheter-related 32 bloodstream infections in the ICU. N Engl J Med 2006;355:2725-2732. 33

5. Pronovost PJ, Goeschel CA, Colantuoni E, et al. Sustaining reductions in catheter related 34 bloodstream infections in Michigan intensive care units: observational study. BMJ 2010;340:309. 35

6. Curran E, Harper P, Loveday H, Gilmour H,, Jones S, Benneyan J, Hood J, Pratt RJ. Results of a 36 multicentre randomised controlled trial of statistical process control charts and structured diagnostic 37 tools to reduce ward acquired meticillin-resistant Staphylococcus aureus: the CHART Project. 38 Journal of Hospital Infection 2008;70;127-135 39

7. Scales DC. Dainty K. Hales B. Pinto R. Fowler RA. Adhikari NK. Zwarenstein M. A Multifaceted 40 intervention for quality improvement in a network of intensive care units. JAMA. 2011;305(4):363-41 372. 42

8. Munoz-Price LS. Dezfulian C. Wyckoff M. Lenchus JD. Rosalsky M. Birnbach DJ. Arheart KL. 43 Effectiveness of stepwise interventions targeted to decrease central catheter associated blood 44 stream infections. Crit Care Med 2012; 40: 1464 1469. 45

9. Bion J. Richardson A. Hibbert P. Beer J. Abrusci T. McCutcheon M. Cassidy J. Eddleston J. 46 47

interventional programme to minimise central venous catheter- blood stream infections in intensive 48

112

care units in England. BMJ Qual Safe. Online First, published on 20 September 2012 as 1 10.1136/bmjqs-2012-001325. 2

3

113

SECTION A - APPENDICES 1 2 A.1 Guideline Development Team 3 Professor Heather P. Loveday (Project Lead), Professor of Evidence-based 4

Healthcare, College of Nursing, Midwifery and Healthcare, University of West 5 London (London). 6

Ms Jennie A. Wilson, Reader, Healthcare Epidemiology, University of West 7 London (London). 8

Dr Jacqui Prieto, Senior Clinical Academic Research fellow, University of 9 Southampton (Southampton). 10

Professor Mark Wilcox, Professor of Medical Microbiology, University of Leeds 11 (Leeds). 12

Professor Robert J. Pratt CBE, Professor of Nursing, University of West London 13 (London). 14

Ms Aggie Bak, Research Assistant, University of West London (London). 15 Ms Jessica Browne, Research Assistant, University of West London (London). 16 Ms Sharon Elliott, Senior Lecturer (Director Clinical Simulation), University of 17

West London (London). 18 Ms Mana Golsorkhi, Research Assistant, University of West London (London). 19 Mr Roger King, Lecturer (Operating Department Practice), University of West 20

London (London). 21 Ms Caroline Smales, Senior Lecturer (Infectious Diseases), University of West 22

London (London). 23 Ms Alison Tingle, Principal Research Programme Officer, University of West 24

London (London). 25 26 27 A.2 Guideline Development Advisory Group 28 Dr Debra Adams, NHS Trust Development Authority 29 Ms Susan Bennett, Lay member 30 Dr Tim Boswell, Nottingham University Hospitals NHS Trust 31 Ms Maria Cann, Lay member 32 Ms Tracey Cooper, South London NHS Trust 33 Dr Peter Cowling, Northern Lincolnshire & Goole Hospitals NHS Trust 34 Ms Judith Hudson, Association Healthcare Cleaning Professionals 35 Ms Theresa Neale, Urology Nurse Specialist, British Association of Urological 36

Nurses (Consultant) 37 Dr Jeff Phillips, Consultant Intensivist and Clinical Lead for Anaesthetics 38

(Consultant) 39 Dr Jacqui Prieto, University of Southampton (Infection Prevention Adviser) 40 Mr Julian Shah, Consultant Urologist, (Consultant) 41 Professor Mark Wilcox, Leeds Teaching Hospitals and University of Leeds 42 Ms Caroly Fry, Department of Health (Observer) 43 Professor Brian I. Duerden CBE,  Duerden Microbiology Consulting Ltd (Chair of 44

the face-to-face meeting) 45 Ms Meg Morse, Administrator officer, University of West London 46

47 48

49 50

114

A.3 Consultation Process 1 2 The following organizations are approached for comment: 3 4 Advisory Committee on Antimicrobial Resistance and Healthcare Associated 5 Infection 6 Association for Continence Advice 7 Association of British Healthcare Industries 8 Association of Healthcare Cleaning Professionals 9 British Association of Critical Care Nurses 10 British Association of Urological Surgeons 11 British Association Urological Nurses 12 British Health Care Trades Association 13 British Infection Association (BIA) 14 British Medical Association (BMA) 15 British Society for Antimicrobial Chemotherapy (BSAC) 16 C-diff Support 17 Chartered Society of Physiotherapy 18 Foundation Trust Network 19 General Medical Council (GMC) 20 Health and Safety Executive (HSE) 21 Health Education England 22 Health Professions Council 23 Health Protection Scotland 24 Healthcare Infection Society (HIS) 25 Healthwatch England 26 HPA Scotland 27 Infection Prevention Society (IPS) 28 Intensive Care Society 29 Medicines and Healthcare Products Regulatory Agency (MHRA) 30 MRSA Action UK 31 N I Public Health Agency 32 NHS Confederation 33 NHS Trust Development Authority 34 Northern Ireland Executive 35 Nursing and Midwifery Council (NMC) 36 Public Health England 37 Public Health Wales Health Protection 38 Royal College of Anaesthetists 39 Royal College of Midwives 40 Royal College of Nursing 41 Royal College of Pathologists 42 Royal College of Physicians 43 Royal College of Radiologists 44 Royal College of Surgeons of England 45 Royal Pharmaceutical Society of Great Britain 46 Royal Society of Medicine 47 Scottish Government 48 Spinal Injury Association 49 The Lee Spark Necrotising Fasciitis Foundation 50 The Patients Association 51 UK Clinical Pharmacists Association 52 Unison 53 Welsh Assembly Government 54

55

115

A.4 Standard Principles Systematic Review Process 1 2 Hospital Hygiene - Systematic Review Process 3

Systematic Review Questions 1. What is the evidence that the patient environment (including clinical

equipment) is a significant factor in the transmission of healthcare associated infection?

2. What is the effectiveness and cost effectiveness of conventional cleaning vs. enhanced cleaning of the patient bed space in reducing environmental contamination and healthcare associated infection?

3. What is the effectiveness and cost effectiveness of antimicrobial surfaces (e.g. silver, copper) in the patient environment in reducing environmental contamination and healthcare associated infection?

4. What is the effectiveness of education interventions in improving healthcare workers knowledge and behaviour in the maintaining a clean patient environment (including clinical equipment) and in reducing environmental contamination and healthcare associated infection?

5. What is the effectiveness of system interventions in driving improvements in hospital environmental hygiene and in reducing environmental contamination and healthcare associated infection?

Databases and Search Terms Used

DATABASES Medline, Cumulative Index to Nursing and Allied Health Litrature (CINAHL), Embase, NEHL Guideline Finder, National Instirure For Health and Clinical Excellence, The Cochrane Library (CDSR, CCRCT, CMR), US Guideline Clearing House, DARE (NHS Evidence, HTA), Prospero

MeSH TERMS infection control; cross infection;, equipment contamination; disease transmission; disinfection; disinfectants; soaps; anti-infective agents; surface-active agents; hospital housekeeping; Hydrogen Peroxide; Silver THESAURUS AND FREE TEXT TERMS hospital hygiene; hospital housekeeper; blood spill; blood exposure; blood splash Search date: Jan 2005-Nov 2012

4

Search Results Total number of articles located = 5944

Sift 1 Criteria Abstract indicates that the article: relates to infections associated with hospital hygiene, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions.

Articles Retrieved Total number of articles retrieved from sift 1 = 164

116

1

Sift 2 Criteria Full Text confirms that the article relates to infections associated with hospital hygiene is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions.

Articles Selected for Appraisal Total number of articles selected for appraisal during sift 2 = 24

2

Critical Appraisal All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion.

Accepted and Rejected Evidence Total number of articles accepted after critical appraisal = 10 Total number of articles rejected after critical appraisal = 14

3

4

117

Hand hygiene - Systematic Review Process 1

Systematic Review Questions 1. What is the effectiveness and cost effectiveness of hand decontamination

preparations on hand hygiene compliance among healthcare workers, reductions in healthcare associated infection, reduction in transient and/or resident skin microorganisms and the removal of organic soil?

2. What is the most effective hand decontamination technique, including duration, for achieving reductions in transient and/or resident skin microorganisms and the removal of organic soil?

3. What is the effectiveness of hand decontamination preparations on user preference and minimising contact dermatitis/ allergy in healthcare workers?

4. What is the effectiveness of system interventions, electronic monitoring and education programmes in increasing hand hygiene compliance among healthcare workers and reducing infection?

5. What is the effectiveness of interventions that provide patients with opportunities to decontaminate their hands while in hospital?

Databases and Search Terms Used

DATABASES Medline, Cumulative Index to Nursing and Allied Health Litrature (CINAHL), Embase, NEHL Guideline Finder, National Instirure For Health and Clinical Excellence, The Cochrane Library (CDSR, CCRCT, CMR), US Guideline Clearing House, DARE (NHS Evidence, HTA), Prospero, PsycINFO

MeSH TERMS infection control; cross infection; equipment contamination; disease transmission; disinfectants; soaps; anti-infective agents; surface active agents; Guideline Adherence; consumer satisfaction THESAURUS AND FREE TEXT TERMS Handwashing; skin; nails; antisepsis; decontamination; WHO Five Moments; Multimodal campaign; patient education; hand hygiene audit; hand hygiene compliance Search date

Jan 2006-Jan 2013 2

Search Results Total number of articles located = 8223

Sift 1 Criteria Abstract indicates that the article: relates to infections associated with hand hygiene, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions.

Articles Retrieved

Total number of articles retrieved from sift 1 = 255

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1 2

Sift 2 Criteria Full Text confirms that the article relates to infections associated with hand hygiene is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions.

Articles Selected for Appraisal Total number of articles selected for appraisal during sift 2 = 78

3

Critical Appraisal All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion.

Accepted and Rejected Evidence Total number of articles accepted after critical appraisal = 17 Total number of articles rejected after critical appraisal = 61

4

5

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Personal Protective Equipment - Systematic Review Process 1 2

Systematic Review Questions

1. What is the evidence that healthcare workers use of clinical gloves is clinically appropriate and cost effective?

2. What is the effect of glove use on hand hygiene compliance? 3. What is the effect of glove material (vinyl, latex or nitrile) on user preference

and hypersensitivity, protection against blood borne infections, glove porosity and tears? (adapted from NICE 139)

4. What is the evidence that the uniforms / clothes of healthcare workers contribute to the transmission of healthcare-associated infection?

5. What is the evidence that the use of protective clothing reduces the risk of transmission of healthcare-associated infection?

6. What is the effectiveness of personal protective equipment (aprons, gloves and mouth/facial protection) in preventing the transmission of blood borne viruses?

7. What is the effectiveness of facial protection (facemasks, respirators) in preventing the transmission of respiratory pathogens?

8. What is the effectiveness of education interventions in improving healthcare workers knowledge and behaviour in the appropriate use of personal protective equipment and reducing infection?

Databases and Search Terms Used DATABASES Medline, Cumulative Index to Nursing and Allied Health Litrature (CINAHL), Embase, NEHL Guideline Finder, National Instirure For Health and Clinical Excellence, The Cochrane Library (CDSR, CCRCT, CMR), US Guideline Clearing House, DARE(NHS Evidence, HTA), Prospero MeSH TERMS

infection control; cross infection; equipment contamination; universal precaution; disease transmission; protective clothing; disposable equipment; masks; gloves, protective; eye protective devices; education; health education, medical education; inservice training; health knowledge

THESAURUS AND FREE TEXT TERMS Infection; contamination; antisepis; universal precaution; disease transmission; disinfection; sterilisation; decontamination; disposable equipment; masks; gloves; face shield; goggles; apron; gown; protective clothes; visor; hood; eye protection devices Search date (Apron, Gloves(AG): Apr 2011-feb 2013), (Facial Protection(FP): Jan 2006-Jan 2013)

3 4 5 6 7 8 9 10 11 12 13

Search Results Total number of articles located = AG (867), FP (8160)

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Critical Appraisal All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion.

Accepted and Rejected Evidence Total number of articles accepted after critical appraisal = AG(6), FP(4) Total number of articles rejected after critical appraisal = AG(0), FP(2)

26 27 28

29

Sift 1 Criteria Abstract indicates that the article: relates to infections associated with protective clothing, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions.

Articles Retrieved Total number of articles retrieved from sift 1 = AG (32), FP (25)

Sift 2 Criteria Full Text confirms that the article relates to infections associated with protective clothing is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions.

Articles Selected for Appraisal Total number of articles selected for appraisal during sift 2 = AG (6), FP (6)

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Sharps - Systematic Review Process 1 2

Systematic Review Questions

1. What are the risk factors associated with sharps injuries in secondary healthcare? (B)

2. What are the changes in legislation in relation to the use and disposal of sharps and the prevention of injuries in healthcare settings?(B)

3. What is the effectiveness and cost effectiveness of using safety needle cannulae vs. standard cannulae on healthcare workers compliance with recommended use and disposal, risk of infection and injury to patients or healthcare workers? (adapted from NICE 139) Note: This question may refer to PVC RQs too.

4. What is the effectiveness and cost effectiveness of healthcare workers using safety needle devices (needle free, retractable needles, safety re-sheathing devices) vs. standard needles on healthcare workers compliance with recommended use and disposal, risk of infection and injury to patients or healthcare workers? (adapted from NICE 139)

5. What is the effectiveness of education interventions in improving healthcare workers knowledge and behaviour in the use and disposal of sharps?

Databases and Search Terms Used

DATABASES Medline, Cumulative Index to Nursing and Allied Health Litrature (CINAHL), Embase, NEHL Guideline Finder, National Instirure For Health and Clinical Excellence, The Cochrane Library (CDSR, CCRCT, CMR), US Guideline Clearing House, DARE(NHS Evidence, HTA), Prospero

MeSH TERMS infection control; cross infection; universal precautions, equipment contamination; disease transmission; needlestick injuries; education; health education; medical education; inservice training; health knowledge THESAURUS AND FREE TEXT TERMS Needles; syringes; sharps; resheathing; safe needle; safe lancet; safe cannula, needle retract; needle covered; needle capped; needle fixed; needle uncapped; needleless; needle free Search date Jan 2005-feb 2013

3

Search Results Total number of articles located = 3989

Sift 1 Criteria Abstract indicates that the article: relates to infections associated with sharps, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions.

Articles Retrieved Total number of articles retrieved from sift 1 = 18

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Sift 2 Criteria Full Text confirms that the article relates to infections associated with sharps is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions.

Articles Selected for Appraisal Total number of articles selected for appraisal during sift 2 = 2

1

Critical Appraisal All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion.

Accepted and Rejected Evidence Total number of articles accepted after critical appraisal = 1 Total number of articles rejected after critical appraisal = 1

2

3

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1 A.5 Short-term indwelling urethral catheters Systematic 2

Review Process 3

Systematic Review Questions 1. What are the clinical indications for the use of short-term urinary

catheters?(B) 2. What is the risk associated with short-term catheterisation in terms of

bacteriuria, CAUTI, other morbidities and mortality?(B) 3. What is the effectiveness (in terms of patient acceptability and reduced risk of

bacteriuria, CAUTI, other morbidities and mortality) and the cost effectiveness of different types of short-term indwelling urinary catheters (material, coatings and design)?

4. What is the most effective catheter insertion technique in terms of patient acceptability and minimisation of urethral trauma, bacteriuria, CAUTI and other morbidities?

5. What is the most effective and cost effective means of maintaining meatal hygiene and a closed drainage system?

6. What is the effectiveness of system interventions in reducing the use and duration of short-term urinary catheterisation to minimize the risk of bacteriuria, CAUTI, other morbidities and mortality?

7. What is the effectiveness of system interventions in improving healthcare

timely removal of indwelling urinary catheters to minimize the risk of bacteriuria, CAUTI, other morbidities and mortality?

Databases and Search Terms Used DATABASES

Medline, Cumulative Index to Nursing and Allied Health Litrature (CINAHL), Embase, NEHL Guideline Finder, National Instirure For Health and Clinical Excellence, The Cochrane Library (CDSR, CCRCT, CMR), US Guideline Clearing House, DARE (NHS Evidence, HTA), Prospero

MeSH TERMS infection control; cross infection; disease transmission; urinary tract infections; urinary catheterization; indwelling catheters; irrigation; biofilms; hydrogen ion concentration; nursing education; nursing care; inservice training

THESAURUS AND FREE TEXT TERMS Urinary catheterisation; urinary tract infection; cross infection; disease transmission; bacteriuria; funguria; encrustation; bladder irrigation; washout; lubrication; urinary dipstick; patient education; quality improvement

Search date Jan 2007-apr 2013

4

Search Results Total number of articles located = 7073

Sift 1 Criteria Abstract indicates that the article: relates to infections associated with

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short-term indwelling urinary catheters, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions.

Articles Retrieved Total number of articles retrieved from sift 1 = 54

1

Sift 2 Criteria Full Text confirms that the article relates to infections associated with short-term indwelling urinary catheters is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions.

Articles Selected for Appraisal Total number of articles selected for appraisal during sift 2 = 16

2

Critical Appraisal All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion.

Accepted and Rejected Evidence Total number of articles accepted after critical appraisal = 10 Total number of articles rejected after critical appraisal = 6

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A.6 Intravascular Access Devices Systematic Review Process

Systematic Review Questions

1. What types of central vascular catheter (material, coating, antibiotic impregnation, cuffed, tunnelled, midline, PICC) and peripheral vascular catheter (material, coating, antibiotic impregnation) are most effective in reducing the risk of catheter-related bloodstream infections and related complications/adverse events including phlebitis, related mortality, catheter-tip colonisation, premature line removal?

2. Which central catheter/peripheral catheter insertion site is associated with the lowest risk of catheter-related bloodstream infection and related complications including (phlebitis, related mortality, catheter-tip colonisation and premature line removal)?

3. What is the evidence that additional ports or lumens increase the risk of catheter-related bloodstream infection) and related complications/adverse events including phlebitis, mortality, catheter tip colonisation and premature line removal?

4. Which infection prevention precautions used for inserting intravascular catheters, are most effective in reducing the risk of CR-BSI and related complications/adverse events including phlebitis, catheter-tip colonisation, premature line removal and mortality?

5. What levels of barrier precautions are most effective in reducing the risk of CR-BSI and related complications/adverse events including phlebitis, catheter-tip colonisation, premature line removal and mortality?

6. What is the most effective skin antisepsis solution/antiseptic impregnated product, for decontamination of the skin prior to insertion of CVC and PVC to reduce the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality?

7. What is the effectiveness of antiseptics vs. antiseptic impregnated products (sponges or cloths) for decontaminating skin the insertion site or surrounding area skin whilst a CVC and PVC is in situ in reducing the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality?

8. What is the evidence for the effectiveness of using antibiotics or antiseptics to lock or flush or clean the catheter hub or entry ports of CVC and PVC in reducing the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality?

9. What is the effectiveness of the low-dose systemic anticoagulation to reduce the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality?

10. Which dressing type is the most clinically effective in reducing the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality and how frequently should dressings be changed?

11. What is the optimal frequency to change or re-site PVC or midline catheters to reduce the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality?

12. What is the evidence for the effectiveness of replacing administration sets to reduce the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality?

13. What is the effectiveness of the prophylactic administration of systemic antimicrobials in reducing the incidence of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and

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mortality? 14. What is the evidence that the needle-safe devices are associated with

increased risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and mortality?

15. What is the effectiveness of system interventions in reducing the risk of CR-BSI and related complications including, phlebitis, catheter-tip colonisation, premature line removal and moknowledge and behaviour relating to the use of CVAD and PVD?

Databases and Search Terms Used DATABASES

Medline, Cumulative Index to Nursing and Allied Health Litrature (CINAHL), Embase, NEHL Guideline Finder, National Instirure For Health and Clinical Excellence, The Cochrane Library (CDSR, CCRCT, CMR), US Guideline Clearing House, DARE (NHS Evidence, HTA), Prospero

MeSH TERMS infection control; cross infection; disease transmission; universal precautions; central venous catheter; bacteremia; chlorhexidine; povidone-iodine; anticoagulants; sepsis; sterilisation; antisepsis; catheterization; peripheral catheterization; peripheral catheter; THESAURUS AND FREE TEXT TERMS PICC; TPN; catheter hub; implantable catheter; catheter port; needle- free devices; needleless connector; intravenous-access; skin preparation; care bundle; Matching Michigan; catheter team, IV team; specialist nurses Search date Jan 2010-feb 2013

Search Results Total number of articles located = 8053

Sift 1 Criteria Abstract indicates that the article: relates to infections associated with intravascular access devices, is written in English, is primary research or a systematic review or a meta-analysis, and appears to inform one or more of the review questions.

Articles Retrieved Total number of articles retrieved from sift 1 = 96

Sift 2 Criteria Full Text confirms that the article relates to infections associated with intravascular access devices is written in English, is primary research or a systematic review or a meta-analysis, and informs one or more of the review questions.

127

Articles Selected for Appraisal Total number of articles selected for appraisal during sift = 27

Critical Appraisal All articles which described primary research, a systematic review or, a meta-analysis and met the sift 2 criteria were independently critically appraised by two appraisers. Consensus and grading was achieved through discussion.

Accepted and Rejected Evidence Total number of articles accepted after critical appraisal = 20

Total number of articles rejected after critical appraisal = 7

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A.7 Systematic Review Process

Initial Search for Published evidence An initial search was made for national and international guidelines and systematic reviews of randomised control trials.

Systematic Review Questions Search questions were based on the scope of the original review and advice from the Guideline Development Group.

Literature Search Databases to be searched were identified together with search strategy, i.e., relevant medical subject headings (MESH), free text and thesaurus terms.

Sift 1 Abstracts of all articles retrieved from the search were reviewed against pre-determined inclusion criteria, e.g. relevant to a review question, primary research / systematic review / meta-analysis, written in English.

Sift 2 Full text of all articles meeting inclusion criteria were reviewed against pre-determined criteria to identify primary research which answers review questions.

Critical Appraisal All articles which describe primary research, a systematic review or, a meta-analysis were critically appraised by two experienced appraisers. Consensus and grading was achieved through discussion in the context of pre-determined grading criteria.