Infection Prevention Strategies— “How Low Can You Go?” · Centers for Disease Control and...

80 June 2008 MANAGING INFECTION CONTROL

Objectives After completion of this self-study activity, the

learner will be able to:1. Define three prevention strategies of facilities that

are targeting zero healthcare-associated infections(HAIs).

2. List the three infections that the Centers forMedicare and Medicaid Services (CMS) will nolonger reimburse as of October, 2008.

3. Describe how to use physical monitors, chemicalindicators and biological indicators to monitor asteam sterilization process.

4. Develop a procedure to address a sterilizer/disinfection process failure.

Education & Training

Test QuestionsCircle the correct answer.

1. Some common infection control strategies used to target forzero healthcare-associated infections (HAIs) include root cause analysis when even one infection occurs, team work andrelentless communication.A. True B. False

2. Centers for Medicare and Medicaid Services will no longerreimburse hospitals for the following infections starting inOctober of 2008 (select three).A. Catheter-associated urinary tract infectionsB. Ventilator associated pneumoniaC. MRSA infectionD. Vascular catheter-associated infectionsE. Surgical site infection-mediastinitis after coronary artery

bypass graft

3. Assessment of medical devices to determine the correct methodof reprocessing includes a risk stratification of items that areconsidered critical, semi-critical and noncritical.A. True B. False

4. Physical monitoring of sterilization processes includes chemicaland biological indicators, as well as time, temperature and pressure recordings.A. True B. False

5. Implant loads may be released for use as long as the results of the biological indicator are subsequently negative andrecorded properly.A. True B. False

6. Non-implant loads should be released based on an evaluation of the available data in the sterilization processes for that load.The decision should be made by a knowledgeable person at the conclusion of the sterilization process.A. True B. False

7. If a load is determined to be nonsterile, remove the sterilizer fromservice, notify Biomedical Engineering and the manufacturer’sservice representative, Infection Control, and Risk Management,and then recall, repack and re-sterilize items that have beenprocessed since the last negative biological indicator.A. True B. False

Many thanks to the team at 3M HealthCare for working with Managing InfectionControl to provide the following accreditedcourse. IAHCSMM has awarded one (1)contact point for completion of this continuingeducation lesson toward IAHCSMM recertifi-cation. The CBSPD has preapproved thisinservice for one (1) contact hour for a periodof five (5) years from the date of publication,and to be used only once in a recertificationperiod. This inservice is 3M Health CareProvider approved by the California Board ofRegistered Nurses, CEP 5770 for one (1)contact hour. This form is valid up to five (5)years from the date of publication. Instructionsfor submitting results are on page 96.

Managing Infection Control and 3M HealthCare will be working collaboratively to providecontinuing education courses in monthlyeditions of Managing Infection Control.

Embracing the goal of "zero infections”by Jo Micek, RN, CIC

Infection Prevention Strategies—“How Low Can You Go?”



8. Key components to prevent infection in all employeeswith patient encounters include a clear understanding ofhand hygiene, standard precautions, aseptic technique,respiratory etiquette, and transmission-based precautions.A. True B. False

9. Semicritical items that are reprocessed should use a tapwater rinse to complete the process.A. True B. False

10. Packaging of supplies for reprocessing should be directedby the type of device to be reprocessed, the method ofreprocessing and the medical device manufacturer’srecommendations.A. True B. False

IntroductionMany of you who read this may have mixed feelings about

the challenges that face infection prevention professionals atthis time. There is the core belief that we, as healthcareproviders, wish to “do no harm” to our patients.

Although we wish we would do no harm, a report from theCenters for Disease Control and Prevention (CDC) updatesprevious estimates of healthcare-associated infections (HAIs). InAmerican hospitals alone, HAIs account for an estimated 1.7million infections and 99,000 associated deaths each year.1 Aswe look at the frequency and type of infections, 36 percent areurinary tract infections (UTI), 20 percent are surgical site infec-tions (SSI), 11 percent are pneumonias and 11 percent arebloodstream infections (BSI).1

The data is compelling and the healthcare industry isfocusing on infection prevention and challenging us to decreasemorbidity and mortality related to infection. Pressure by thepublic, private sector groups, collaborative, regulatory groups andlegislation is growing and pushing for improvement.

Targeting ZEROAt the Association for Professionals in Infection Control and

Epidemiology (APIC) 2007 annual conference, Denise Murphy,MPH, BSN, RN, CIC, president of APIC, challenged infectionprevention professionals to “Pay it Forward.”2 She presentedstories of healthcare facilities around the world that haveembraced the goal of “zero infections” and have been successful.In her presentation she discussed common infection controlstrategies in these successful programs to eliminate HAIs:1. They set their goal at zero (for BSI, VAP [ventilation-asso-

ciated pneumonia], SSI and MRSA). 2. Strong leadership, physician support, and departmental

champions were engaged.3. All used the bundle approach to evidence-based preven-

tion measures to all patients at risk for HAIs.4. They did real-time root cause analysis when even one

infection occurred.

5. HAIs were personalized. They made the informationabout people rather than rates.

6. Data management was reliable; data was sharedroutinely with the frontline staff.

7. They communicated relentlessly to key staff andleadership.

8. Teamwork was a priority and team success was celebrated.9. They marketed the value of infection prevention to

executive leadership.2

Centers for Medicare and Medicaid Services (CMS)has focused on prevention of pneumonia and influenzawhich are the fifth leading causes of death in the UnitedStates for patients age 65 and older. Efforts to improveimmunization of both inpatients and healthcare workershave been tracked and can be found at the CMS Web siteHospital Compare (http:// www.hospitalcompare.hhs.gov).3The Web site provides detailed information about the pastperformance of every Medicare and Medicaid certifiedhospital in the country.3

As of October 2008, the CMS will no longer reimbursehealthcare facilities for costs associated to certain HAIs thatcould have been reasonably prevented through the use ofevidence-based guidelines.

The final rule (as mandated by Section 5001© of theDeficit Reduction Act) states that hospitals “will not receiveadditional payment for cases in which one of the selected conditions was not present on admission.” That is, the casewill be paid as though the secondary diagnosis was notpresent. The selected infections listed include: Catheter-associated urinary tract infections; Vascular catheter-associated infections; Surgical site infections-mediastinitis after coronary

artery bypass graft.

Reporting of conditions already present on admission(POA) from those acquired during the hospitalizationstarted in October of 2007.4 Conditions being consideredfor FY2009 and for further analysis are on Table 1. TheFinal Rule introduced three different categories of conditions that, when present, trigger a higher payment aseither a complicating condition (CC) or major compli-cating condition (MCC).

A National Collaborative such as the Institute forHealth Care Improvement (IHI.org) is moving from a100,000 Lives Campaign to 5 Million Lives Campaign with 3,100 hospitals participating with other national andlocal improvement efforts to save an estimated 122,000 livesin 18 months.5 The Surgical Care Improvement Projectprovides tools, guidance, and networking opportunities withdemonstrated success in prevention of HAIs.



CATEGORY

Conditions selected for implementation These conditions will have payment implications

beginning in October 1, 2008.

Conditions being considered for FY2009 IPPS rulemaking These conditions raise one or more implementation or

policy issues that need to be resolved before they canbe selected. CMS will work to address these issues and propose to reconsider these conditions during the FY 2009 IPPS rulemaking process.

Conditions needing further analysis After exhaustive consideration, CMS determined

that further analysis is required before considering these conditions.

CONDITIONS

Serious Preventable Events • Object left in during surgery (998.4 CC) • Air embolism (999.1 MCC) • Blood incompatibility (999.6 CC)

Catheter Associated Urinary Tract Infection, 996.64 CC & one ofthe following specific infection codes: 112.2, 590.10, 590.11, 590.2,590.3, 590.81, 590.89, 590.9, 595.0, 595.3, 595.4, 595.81, 590.89,595.9, 597.0, 597.80, 599.0

Pressure Ulcers (707.00-.01 & 7-7.09 CCs; 707.02-09 MCCs) Vascular Catheter Associated Infection (999.31 CC) Surgical Site Infection—Mediastinitis after Coronary Artery Bypass

Graft (CABG) Surgery (519.2 MCC & 36.10-.19) Falls and Trauma—Fractures, Dislocations, Intracranial Injuries,

Crushing Injuries, and Burns (Codes will be considered in FY2009IPPS Proposed Rule)

Ventilator Associated Pneumonia (VAP) (Codes will be considered in FY2009 IPPS Proposed Rule)

Staphylococcus Aureus Septicemia (038.11 + 995.91, 998.59, 999.3 MCCs)

Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) (DVT: 453.40-.42 CCs; PE: 415.11 & 415.19 MCCs)

Methicillin Resistant Staphylococcus Aureus (MRSA) (Codes will be considered in FY2009 IPPS Proposed Rule)

Clostridium Difficile-Associated Disease (CDAD) (008.45 CC) Wrong Surgery (Codes will be considered in FY2009 IPPS

Proposed Rule)

Getting Back to Basics“One means of eliminating as many HAIs as possible will be

zero tolerance for not adhering to infection prevention measuresand broken systems that lead to harm.”2 A journey to zero mustinclude all healthcare providers throughout the system.

Do we take it for granted that we understand the basics ofinfection prevention? It can be as simple as asking yourself thequestion, “Do I follow the basics?”

We know hand hygiene is an integral part of our job duties.We know:1. Hand hygiene—has been well establishedas a critical factor in

the transmission of infection. Healthcare personnel shouldunderstand proper hand hygiene practices and recommendationsand consistently practice according to those recommendations.Key Concepts• Hands contaminated with transient bacteria are a primary

means of transmission.• Hands without healthy skin are more susceptible to

becoming colonized with transient bacteria, includingmultidrug-resistant organisms (MDRO).

• Healthcare workers need to clearly understand when andhow to perform hand hygiene. When using an antiseptic or alcohol-based hand rub it is important to communicate

The Joint Commission (TJC) and the National PatientSafety Goals (NPSG) continue to push these basic prin-ciples of infection prevention in the requirementscurrently under field review at this time with a deadlinefor comment of April 8, 2008.22

NPSG Requirement 7C Implement best practices to facilitate the prevention of

multiple drug-resistant organism (MDRO) infections inacute care hospitals, focusing on methicillin-resistantStaphylococcus aureus (MRSA) and Clostridium difficile-associated disease (CDAD).NPSG Requirement 7D

Implement best practices for prevention of catheter-associated bloodstream infections (CABSI).NPSG Requirement 7E

Implement best practices for prevention of surgicalsite infections (SSI).NPSG Goal 13

Encourage patients’ active involvement in their owncare as a patient safety strategy. (Includes implemen-tation expectations related to hand hygiene,respiratory hygiene, contact precautions, and preven-tion of adverse events for surgical patients.)

Table 1. Centers for Medicare and Medicaid Services (CMS) FY2008 Inpatient Prospective Payment System (IPPS) Final Rule4


the manufacturer’s recommendations for the volume ofthe product. Clear communication should be provided onwhen alcohol-based hand products can be used.

• Healthcare worker adherence to hand hygiene recommen-dations depend on clearly understood policies, targetededucation, healthy skin condition of the hands, the conven-ience of hand hygiene products, and monitoring ofperformance with feedback.11

Now let’s ask some questions of ourselves. • If everyone washed their hands the way I do would

infections go up or down?• Do I use the right amount of alcohol-based hand

product?• Do I wash my hands after I remove my gloves?

2. Standard Precautions—is the basis for all types of precau-tions to prevent transmission of infectious agents. Infectiousagents may be present in blood body fluids and body secretions.Key Concepts• Knowledge of proper donning and removal of personal

protective equipment (PPE).• Gowns should be used to prevent exposure to the

employee’s skin or clothing to blood, body fluids andbody secretions.

• Gloves should be worn to prevent exposure to blood,body fluids and secretions.

• Mask, eye protection and face shield should be used duringpatient care activities that may generate splashes or spraysof blood, body fluids and secretions.

• Soiled patient care equipment should be handled in amanner that prevents the transfer of microorganisms toothers or to the environment.

• Environmental surfaces or objects that are cleaned bythe employee must follow established manufacturer’sguidelines. Employees should be familiar with thoseprocedures and the correct PPE needed to perform thoseprocedures.

• Needles and other sharps should be handled with care.Use of a safety device is preferred. Waste disposal inappropriate puncture-resistant container.

• Use of protective equipment for resuscitation of patientsto avoid mouth contact.12

Now let’s ask some questions of ourselves. • Do I have the right PPE in my work space to do my

duties?• Do I have the right size PPE?• Are puncture-resistant containers placed in areas that are

easily accessed and are they anchored to prevent themfrom tipping over?


3. Respiratory hygiene/cough etiquette—In response to the experience with SARS outbreaks in 2003, standard precautions incorporated source containmentof respiratory secretions. These measures apply to visitors, patients and any person with signs of respi-ratory infection.Key Concepts • Instruct symptomatic persons to cover mouth/nose

when sneezing/coughing. • If tissues are used they should be promptly

discarded in a no-touch receptacle.• Hand hygiene is performed after soiling of hands

with respiratory secretions.• Don a mask if unable to cover mouth/nose.12

Now let’s ask some questions of ourselves.• Do I have the supplies I need to follow good respi-

ratory etiquette?• Am I putting other employees at risk by not

following these practices?

4. Transmission-based precautions—This work practicecan be as unique as each healthcare facility. TheHealthcare Infection Control Practices AdvisoryCommittee (HICPAC) published updated guidelines ontransmission-based precautions. The 2007 Guidelinefor Isolation Precautions addresses multidrug-resistantorganisms and evidence-based practices to help combattheir spread.12 In different institutions signage mayvary and depending on the communicated expectationsof the facility the work practices can be varied. Ahealthcare worker may work at more than one facilityand see different signage and expectations from onefacility to the next.Key Concepts• The patient who has not been identified or is

not suspected of being colonized or infected witha transmissible pathogen represents a risk toother patients.

• Risk of transmission is determined by hostsusceptibility, route of transmission, duration andintensity of exposure.

• Risk of transmission is also determined by avail-ability and behavior of healthcare providers withpatient contact.

• Appropriate and timely initiation of transmission-based precautions based on clinical diagnosis.12

You may or may not be required to go into isolationrooms, however, you may be responsible for setting up isolation carts and distributing them throughout your facility.

87June 2008 MANAGING INFECTION CONTROL


If so, questions to consider include:• Do I have established lists for different types of

isolation or a general list for all isolation carts?• What are my responsibilities for providing PPE for

these carts?• If I have to go into isolation rooms, am I comfortable

reading the signs and following them?• Where can I find this information if I need it?

5. Aseptic Technique—is basic to all healthcare practicesettings. This technique was originally developed for the operative setting, however, it has been modified for use on patients undergoing invasive procedures orwound management.Key ConceptsSterile practices include (but are not limited to):• Providing maximum reduction of skin microorganisms

without damaging tissue before donning sterile gloves.• Applying hospital-approved antiseptics according to

manufacturer’s recommendations.

• Removal of hair from site, only when necessary,using clippers.

• Use of barriers to decrease the risk of transmissionby maintaining a sterile field.

• Appropriate attire to support this practice.• Gloves should be sterile.• Procedures should be performed in rooms that

meet current regulations.13

Clean technique refers to practices that reduce the numbers of microorganisms and minimize the risk oftransmission from personnel or the environment to patients.

• Proper hand hygiene.• Use of single-use patient devices and equipment.• Properly reprocessed reusable devices.• Use of barriers to reduce microbial contamination

from personnel to patient such as gloves, gowns andhair coverings.

• Gloves can be clean or sterile depending on the typeand extent of the wound care procedure.13

Device Classification

Critical (enters steriletissue or vascularsystem) Implant,scalpels, needles, othersurgical instruments, etc.

Semicritical (touchesmucous membranes)Flexible endoscopes,laryngoscopes, entotrachal tubes andother similar instruments.

Noncritical (touchesintact skin) tethescopes:tabletops, floors, etc.

Spaulding Process Classification

Sterilization:Sporicidal chemical,prolonged contact

High-level disinfection:Sporocidal chemical:short contact

Intermediate-leveldisinfection

Low-level disinfection

EPA ProductClassification

Sterilant/disinfectant

Sterilant/disinfectant

Hospital disinfectant with label claim for tuberculocidal activityHospital disinfectantwithout label claim fortuberculocidal activity



If so, questions to consider include:• Can I readily delineate my clean and

dirty areas?• Is my area organized to prevent cross

contamination?• Does my work practice support this?• Do I recognize when there is a break in

technique and respond accordingly?

These basic concepts are the foundation ofinfection prevention work practices and areessential skills necessary to prevent infection forall healthcare providers. Many of these basicprinciples are echoed throughout guidelines andrecommendations of many professional organi-zations, and provide opportunities to movetoward our target of zero.

Educating healthcare workers according totheir level of responsibility in the healthcaresetting on risk factors for HAIs, clinical indica-tion of HAIs and prevention measures was a strategy utilized by many of the facilitiestargeting zero. This concept of compliance withinfection prevention practices and zero tolerancefor noncompliance with established recommendedpractices is echoed throughout organizationsdetermining best practices for reprocessing ofour instruments.

Properly Reprocessed Medical Devices

CDC’s National Nosocomial InfectionsSurveillance (NNIS) system, which monitorsreported trends in nosocomial infections (HAIs) inparticipating U.S. acute care hospitals, finds that:

• 38 percent of all HAIs in a surgicalpatient are surgical site infections.

• 4 percent to 16 percent of all HAIsamong all hospitalized patients aresurgical site infections.

• 2 percent to 5 percent of patients under-going surgery will develop a surgicalsite infection.

• The length of stay related to a surgical site infection can increasean average of 7.5 days costing an estimated $130 million to $845million per year in the United States.5,8

The World Alliance for Patient Safety initiated work on the secondGlobal Patient Safety Challenge in January 2007. The initiative, “SafeSurgery Saves Lives,” aims to improve the safety of surgical care aroundthe world. By focusing attention on surgery as a public health issue, theWorld Health Organization is recognizing the importance of improving the safety of surgical care.14

The risk of introduction of pathogens that could lead to an infection iswell recognized. Failure to properly process these medical devicesincrease the risks of person-to-person transmission (e.g., hepatitis B virus)and the transmission of environmental pathogens.15

The most important role of healthcare workers responsible for reprocessing medical devices is to ensure established work practices are done consistently and produce properly reprocessed medical devicesfor use.

The most important role of healthcare workers responsible for reprocessing medical devices is to ensure established work practices

are done consistently and produce properly reprocessed medical devices for use.

Table 2. Spaulding Definitions for Medical Device Reprocessing16

Modified from Favero MS, Bond WW: Chemical disinfection of medical and surgical material. In:Block SS, ed: Disinfection, sterilization and preservation, ed. 4 Philadelphia, 191 Lea & Febiger.



ASSESSMENT OF THE DEVICE TODETERMINE THE PROCESS TO USE

E.H. Spaulding developed guidance tohelp determine the degree of reprocessing that should be done on patient care items. He separated items into the following threecategories: critical items, semicritical items,and noncritical items (see Table 2 on page 88).

Noncritical items are those items thatcome in contact with intact skin which is aneffective barrier. Most noncritical items can becleaned in the area they are used.

Key Concepts• Many Environmental Protection

Agency (EPA) registered disinfectantshave a 10 minute label time for expo-sure of the chemical to the surface. Ithas been demonstrated by multipleinvestigators that these disinfectants areeffective against vegetative bacteria,yeasts, mycobacteria and viruses atexposure times of 30 to 60 seconds.12

• Manufacturer’s recommendations needto be checked to assure the disinfec-tant can be safely used to clean the product.

Semicritical items are items that comeinto contact with mucous membranes and non-intact skin. These items should be free ofall microorganisms but may have a smallnumber of bacterial spores present.

Key Concepts• These items require at a minimum

high-level disinfection using chem-ical sterilants.

• Chemical compatibility with thedevice and the effect of extended use of the disinfectant on the deviceshould be considerations whenselecting a disinfectant.

• Should be rinsed with sterile waterafter high-level disinfection to preventcontamination with organisms thatmay be present in tap water.

• If tap water or a filtered water rinse isused, it should be followed with analcohol rinse and forced air drying.17

• Reprocessed items should be driedand stored in an area that protectsthem from possible contamination.



Critical items are items that would come in contact or enter steriletissue or the vascular system.

Key Concepts• These items may be purchased sterile or should be sterilized.• Manufacturer’s guidelines for proper cleaning and sterilization,

including running the correct sterilization cycle should be followed.18

Questions to consider:• Are new items checked to assure they are being cleaned according

to the degree of exposure? If so, do I know who to ask if I havequestions? Who makes those determinations?

• Are the items being sterilized according to the manufacturer’sinstructions for use?

• Are extended steam sterilization cycles (cycle longer than theminimum sterilizer manufacturer recommend cycle) being used if required?15

CLEANINGCleaning is defined as the removal of foreign material from objects

and is normally accomplished using water with detergents or enzymatic

products. This is a critical step in the success ofdisinfection or sterilization which require theitem to be absent of foreign material that couldinterfere with its reprocessing.

Key Concepts• Cleaning can be done manually if there

is an absence of a mechanized processor if the item would be damaged if anautomated process was utilized.

• Manual cleaning uses two methods. Thefirst is friction due to mechanical scrub-bing or rubbing and the second is usingfluids under pressure to remove foreignmaterial from channels after brushing.

• Use of a washer-disinfector shouldinclude:> Careful attention to proper loading

of the instruments;> Instruments should be disassem-

bled and hinges open.

INSTRUMENT INSPECTION Inspection of the instruments ensures

instruments are in good working order/alignmentbefore they are processed.

Key Concepts• Use a well-lit clean area;• Instruments should be dry before you

check them;• Check that the serrations of each instru-

ment meet evenly;• Check that the ratchets close easily and

that they do not spring open; • Check that the instrument opens and

closes easily;• Check for all parts of the instrument

(e.g., screws of the speculum are inplace);

• Leak test and examine flexible endo-scopes to assure proper operation;

• Coat instruments with a water-solublelubricant (instrument milk) to protectfrom corrosion and to provide lubrica-tion for the hinges following lubricantlabel guidelines;

• Items with lumens should first be moistened with distilled or demineral-ized water;

• If imperfections are found, separate outand follow agency policy for dealingwith broken equipment.15,18



Questions to consider:• Do I have the right PPE to do cleaning safely?• Do I know how to operate the equipment and check

solutions, readings and understand what readings ortriggers require action?

• Do my departmental procedures clearly communicatethe types of chemicals that should be used throughoutthe process?

INSTRUMENT PACKAGINGInstrument packaging ensures that the protective coverings

suit the type of sterilization.Key Concepts• The protective coverings and device being sterilized

must be assessed to assure that the packaging and steril-ization processes meet the manufacturer’s requirementsfor the product being sterilized and the sterilizer;


• If commercially customized organizing trays orcassettes are used, the tray’s manufacturer mustprovide scientific documentation of the ability tosterilize and store the tray;

• Instruments should be packaged in an acceptablepackaging material to allow adequate contact of sterilant with all surfaces;

• Manufacturer’s guidelines should be followed if arigid sterilization container system is used.

• Paper/plastic peel pouches should not be placedinside container systems.17

MONITORING THE STERILIZATION PROCESSESThree types of monitors are used to evaluate the

effectiveness of a sterilization process.Physical Monitors provide real-time assessment of the

sterilization cycle conditions and provide permanent records(charts, digital records). Read and initial physical monitoringat the end of each sterilization cycle to detect sterilizationproblems, such as incorrect cycle parameters for the load andcycle parameters not achieved as soon as possible.17,21

Chemical Indicators (CIs) are designed to respond witha chemical or physical change to one or more of the physicalconditions within the sterilizing chamber. Chemical indicatorsassist in the detection of potential sterilization failures thatcould result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer.15 Chemical indicators are used with physical monitors and biological indicators to assess the efficacy of the sterilization process.

External chemical indicators (Class 1 CIs) should be usedon the outside of each package unless the internal CI is visible todenote that the package has been exposed to the physical condi-tions of the sterilization process.17,21 This should be checkedafter sterilization and before use.21 If the external CI has notreached its appropriate endpoint, the package should not be used.

Internal chemical indicators should be used in eachpackage, tray or container to be sterilized. This may be asingle variable (Class 3), a multi-variable (Class 4), or integrating (Class 5) indicator, but Class 4 and Class 5 CIsprovide additional information.18 The CI should be placed inthe most challenging area for steam penetration.18,21 If theinternal CI has not reached its appropriate endpoint, thepackage should not be used. A supervisor should use profes-sional judgment to determine if the entire load may not beproperly sterilized by evaluating the other monitoring tools.21

A Class 5 integrating indicator may be used inside aprocess challenge device (PCD) that is representative of the load to monitor loads that do not contain implantables.21

The load should not be used if the Class 5 integrating indicatorhas not reached its appropriate endpoint.

A Class 5 integrating indicator should be used inside thebiological indicator process challenge device (BI PCD) tomonitor loads that contain implants. “The load should be quarantined until the results of the BI testing are available.”21

The usage of Class 6 emulating indicators are notaddressed in AAMI or AORN recommended practices.

Bowie-Dick Test Packs are used each day in eachdynamic-air-removal steam sterilizer to detect air leaks, inadequate vacuums and steam quality.17,21

Biological Indicators (BIs) are the only sterilizationprocess monitoring devices that provide a direct measure ofthe lethality of the process.21 To provide useful information,the appropriate BI must be chosen for the type of sterilizationprocess being performed, placed in a PCD that is representativeof the load being processed and incubated according to manufacturer’s instructions. BI PCDs are to be used to:

• Routinely monitor sterilizers at least weekly, but preferably every day that the sterilizer is in use;

• Routinely monitor each type of cycle for which a sterilizer is designed to be used;

• Monitor each type of tray configuration routinelyflash sterilized;

• Monitor each implant load, quarantining the loaduntil the BI is negative;

• Perform sterilization qualification testing;• Perform product testing.21

Running a BI in each load will ensure that all of therequired testing is performed, will ensure patient safety byusing a consistent method to release each load, will reduce the cost of recall and the chance that a nonsterile medicaldevice was released for use.

Routine Load releaseNon-implant loads—release of these loads should be

an active decision based upon evaluation of the available data(physical monitors, chemical and biological indicators) fromthe sterilization process for that load. The decision to releasethe load should be made by a knowledgeable person at theconclusion of the sterilization process.

Implant Loads—sterilization of implant loads must be closely monitored and each load containing an implantshould be quarantined until the BI test is negative.17,21 In anemergency quarantine is allowed to be broken under certaindocumented medical exceptions.21

Key Concepts• Physical monitors should be read and initialed at

the end of each cycle.• External CIs should be read before the package is

released for use.




• The internal CI is retrieved when the package/container is opened by the user.

• Sterilizers should be routinely monitored with a BI PCD weekly,preferable daily.

• A BI PCD should also be used with each implant load and implantsshould not be released until the BI is negative.

• A BI PCD should also be used for sterilization qualification testing.• The user should be trained and knowledgeable and demonstrate

competency in interpretation of the CI/BI.• Frequency of use of indicators should be, at a minimum, used according

to established standards and manufacturer’s recommendations.• Using BIs in every load will improve patient safety by detecting all

sterilization process failures and applying the same high standard ofcare for all patients.

The goal of the sterilization process is to destroy all microorganisms onthe surface of an item or fluid to prevent disease transmission associated withthe use of that item. Consideration of the material the device is made of willimpact the type of sterilization utilized. The item must be able to withstand the process of sterilization without loss of integrity or function of the device.

Questions to consider:• Do I know which type of processing should be done for each device

that comes to my area? If not, do I know who to ask?• Do I know what type of CIs go in which type of item to

be processed?• Do I know what type of BI PCD to use for each sterilization cycle tested?• Do I know how to interpret the CI and BI results?• Have the healthcare workers who will be opening and checking

the internal CIs been educated on how to interpret the indicator?• Do I consistently document according to my procedure?• Do I quarantine implants until the BI is negative?• Have we evaluated how often we use indicators and determined at

what interval we will monitor our sterilizer loads such as monitoringeach load with a BI and quarantining to eliminate recalls?

• Are there healthcare workers using sterilizers and reprocessing equipment that have not been trained?

STERILIZATION PROCESS FAILUREIf physical monitoring of a cycle indicates any malfunction and if the

malfunction cannot be corrected immediately, the cycle should be terminatedin accordance with manufacturer’s guidelines and an investigation should beconducted.19,21 If the sterilization cycle has been completed and the chemicalor biological indicator indicates a questionable cycle the same type of investigation of the sterilizer should be conducted.

The load should be considered nonsterile and the sterilizer should beremoved from service. When a load is recalled the typical steps include:1. Immediate shut down of the sterilizer;2. Notification of Biomedical Engineering, Infection Control, and Risk

Management;3. Recall and repack and re-sterilize items that have been processed since

the last negative BI.17,21


Key steps to investigate an exposure investigation after a sterilization or disinfection process failure.19

The steps are:1. Confirm disinfection or sterilization reprocessing failure

did occur. 2. Embargo any improperly disinfected/sterilization items.

All items reprocessed since the last successfulprocessing (as demonstrated by process measures and/or physical, chemical or biological indicators) should be embargoed.19

3. Immediate shut down of the equipment in question untilits proper function can be demonstrated. This mayinclude notification of the sterilizer manufacturer repre-sentative to perform repairs or evaluation of the unit.

4. Inform key stakeholders including risk management, the medical director, nursing director, the involvedmedical/surgical units and personnel involved in the sterilization/disinfection processes. A face-to-face meetingis recommended to assure complete communication ofthe facts with feedback from all attendees.


Thorough investigation of brokensystems that may lead to patientharm echoes a culture of safetyand commitment that can move us forward on our journeytoward “targeting zero.”

5. A complete and thorough evaluation of the cause of the sterilization/disinfection failure should be completedpromptly. Critical to this process is careful tracking anddocumentation of items that have been reprocessed withaccurate documentation of the results of each load.

6. The infection prevention specialist will develop a linelisting of those patients who have potentially been



exposed. This line list will include the patient name, identification number, date(s) of exposure,contaminated device used, underlying risk factors forinfection, whether an infection developed and anyother adverse events.

7. Once the failure of disinfection or sterilization has been documented with possible patient exposure to a contaminated item, it is crucial to determine whether the failure could result in an adverse patient event.Assessing risk should always be based on a review of the scientific literature and/or compliance withnational guidelines.

8. All stakeholders should be kept informed of the progressof the investigation.

9. An hypothesis should be developed regarding the potential mechanisms of the failure. Corrective actionsshould be completed and any item that has been identified as a part of the failure should be reprocessed.

10. Develop a method to assess potential adverse patientevents. Specific lab tests may be necessary such as

cultures and/or testing for possible bloodborne pathogens.Access to specific tests and receipt of results should beeasily accessible by the patients.

11. In conjunction with the legal department notify appropriate State and Federal authorities if required byregulation or law.

12. Consider patient notification.13. Develop a long-term follow up plan.14. Perform an after action report for the appropriate or health-

care system committee(s).

Questions to consider:• Do I know what triggers a concern regarding

disinfection and sterilization?• Should I be concerned if there is water or utility

disruption in my facility? If so, how would thatimpact the operations in my department?

• How often should I monitor with a BI PCD to reduceand possibly eliminate recalls (e.g., every load, daily,or weekly)?



1. A2. A, D, E3. A4. A5. B

6. A7. A8. A9. B

10. A

ANSWERS

SummaryPrevention of surgical site infections is

a multifaceted issue that involves thepatient, the healthcare workers, the environ-ment and the medical devices that are used.The challenge to healthcare providers is tominimize the risk for surgical site infectionthrough evidence-based processes that limitthe risks and provide our patients with thesafest possible environment. Taking time to“check” your practices and assure that weutilize “best practices” as we reprocessmedical devices, along with thorough inves-tigation of broken systems that may lead topatient harm echoes a culture of safety andcommitment that can move us forward onour journey toward “targeting zero.” ✛

References1. Estimates of Healthcare-Associated Infections,

Division of Healthcare Quality Promotion(DHQP), May 30, 2007.

2. Murphy, DM. Go for Zero the Pay it Forward,APIC News, Fall 2007.

3. CMS, Hospital Compare website, http://www.hospitalcompare.hhs.gov.

4. Centers for Medicare and Medicaid Services,Hospital acquired Conditions (Present onAdmission indicator); http://www.cms.hhs.gov/HospitalAcqCond/06_Hospital-Acquired%20Conditions.asp accessed 3/10/08.

5. Million Lives Campaign, Surgical Site InfectionPrevention, http://www.ihi.org/ihi/Topics/PatientSafety/SurgicalSiteInfections/SurgicalSiteInfectionsCaseForImprovement.

6. Association for Professionals in InfectionControl and Epidemiology. Dispelling themyths: the true cost of health-care associatedinfections [white paper] February 2007.

7. Siegel JD, Rhinehart E, Jackson M, Chiarello L,and the Healthcare Infection Control PracticesAdvisory Committee, 2007 Guideline forIsolation Precautions: Preventing Transmissionof Infectious Agents in Healthcare Settings,June 2007 http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf.

8. Overview of 5 Million Lives Campaign, IHI.org(accessed 3/10/08).

9. Pay it Forward, Supplemental Resources http://www.apic.org/Content/NavigationMenu/PracticeGuidance/PayItForward/Targeting_Zero.htm.

Nursing CE Application FormThis inservice is approved by the California Board of Registered Nurses, CEP

5770 for one (1) contact hour. This form is valid up to one (1) year from the date of publication.1. Make a photocopy of this form.2. Print your name, address and daytime phone number and position/title.3. Add the last 4 digits of your social security number or your nursing license number.4. Date the application and sign. 5. Answer the true/false CE questions. KEEP A COPY FOR YOUR RECORDS.6. Submit this form and the answer sheet to: 3M Sterilization Assurance, Attn HC4160 RR Donnelly Fulfillment Services 585 Hale Ave N., Oakdale, MN 55128-99357. For questions or follow-up, contact [email protected]. Participants who score at least 70% will receive a certificate of completion

within 30 days of Managing Infection Control’s receipt of the application.

ApplicationPlease print or type.

Name______________________________________________________________

Mailing Address______________________________________________________

City, State, Country, Zip _______________________________________________

Daytime phone ( )__________________________________________

Position/Title_______________________________________________________

Social Security or Nursing License Number ________________________________

Date application submitted _____________________________________________

Signature __________________________________________________________Offer expires June 2013

On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this programfor the following:

1) Overall content ___________________

2) Met written objectives ______________

3) Usability of content ________________

Sterile Process and Distribution CEU InformationCEU Applicant Name _________________________________________________

Address___________________________________________________________

City____________________________ State________ Zip Code ______________

The CBSPD (Certification Board for Sterile Processing and Distribution) haspre-approved this inservice for one (1) contact hour for a period of five (5) years fromthe date of publication. Successful completion of the lesson and post test must bedocumented by facility management and those records maintained by the individualsuntil recertification is required. DO NOT SEND LESSON OR TEST TO CBSPD.

For additional information regarding Certification contact: CBSPD, 121 StateHwy 31N, Suite 500, Flemington, NJ 08822 or call 908-788-3847 or visit the Web siteat www.sterileprocessing.org.

IAHCSMM has awarded one (1) contact point for completion of this continuingeducation lesson toward IAHCSMM recertification.

<01/08>



10. Sehulster LM, Chinn RYW, Arduino MJ, Carpenter J, Donlan R,Ashford D, Besser R, Fields B, McNeil MM, Whitney C, Wong S,Juranek D, Cleveland J. Guidelines for environmental infectioncontrol in health-care facilities. Recommendations from CDC and theHealthcare Infection Control Practices Advisory Committee (HICPAC).Chicago IL; American Society for Healthcare EngineeringAmericanHospital Association; 2004.

11. Underwood, MA, Hand Hygiene. Association for Professionals inInfection Control and Epidemiology (APIC), Text of InfectionControl and Epidemiology, 2nd Edition, 2005.

12. Georgia. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and theHealthcare Infection Control Practices Advisory Committee, 2007Guideline for Isolation Precautions: Preventing Transmission ofInfectious Agents in Healthcare Settings, June 2007.

13. DeCastro MG, Iwamoto, P, Aseptic Technique. Association forProfessionals in Infection Control and Epidemiology (APIC) Text ofInfection Control and Epidemiology, 2nd Edition, 2005.

14. World Alliance for Patient Safety, Second Global Patient SafetyChallenge, “Safe Surgery Saves Lives”, Jan, 2007: http:// www.who.int/patientsafety/challenge/safe.surgery/en/index.html.

15. Nelson, DB, Multi-society Guideline for Reprocessing FlexibleGastrointestinal Endoscopes, SHEA Position Paper. Infection Controland Hospital Epidemiology; July 2003.

16. Favero M, Bond W. Chemical disinfection of medical surgical mate-rial. In: Block S, editor. Disinfection, sterilization, and preservation.5th edition. Philadelphia:Lippencott, Williams and Wilkens; 2001. p. 881-917.

17. Recommended Practices for Sterilization in Perioperative PracticeSettings. Association of periOperative Registered Nurses. AORNStandards, Recommended Practices, and Guidelines. 2007.

18. Recommended Practices for Selection and Use of Packaging Systemsfor Sterilization. AORN Standards, Recommended Practices, andGuidelines.2007.

19. Rutala WA, Weber DJ, How to Assess Risk of Disease Transmissionto Patients When There is a Failure to Follow RecommendedDisinfection and Sterilization Guidelines. Disinfection, Sterilizationand Antisepsis, 2007.

20. Rutala WA, An Overview of Disinfection and Sterilization inHealthcare Facilities, Disinfection, Sterilization and Antisepsis; 2007.

21. Association for the Advancement of Medical Instrumentation.Comprehensive guide to steam sterilization and sterility assurance inhealth care facilities. ANSI/AAMI ST79: 2008.

22. The Joint Commission Draft, 2009 National Patient Safety Goals forHospitals & Critical Access Hospitals. http://www.jointcommission.org/NR/rdonlyres/5928FA30-6BAB-4017-8DF6-5545E5470154/0/09_Hospital_NPSG_FR.pdf (accessed 3/11/2008).

Jo Micek, RN, CIC, is an infection prevention coordinator atLiberty Hospital in Liberty, Mo. Ms. Micek lectures on infectionprevention and control and is a member of the Missouri BasicTraining Program for Infection Control Professionals.

Copyright©2008/Workhorse Publishing L.L.C./All Rights Reseved. Reprint with permission from Workhorse Publishing L.L.C.

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