Accreditation and Infection Control

Marcia R Patrick, MSN, RN, CICTacoma, WA

November 7, 2013

I have nothing to declareNo off-label use of medications will be discussedUse of brand names and images is for illustration only, no endorsement is implied

Be familiar with the salient points of the CMS Infection Control Worksheet

Discuss three critical injection practices to prevent transmission of bloodborne pathogens in the ASC

Describe at least three critical elements in safely and adequately performing high-level disinfection in the ASC

Objectives

Requires all ASCs that accept money from CMS meet specific Infection Control requirements

Result of disease outbreaks in ambulatory pts. IC requirements included in all accreditation

surveys◊ Accreditation Association for Ambulatory Health Care (AAAHC)◊ American Association for Accreditation of Ambulatory Surgery Facilities

(AAAASF)◊ American Osteopathic Association (AOA)◊ The Joint Commission (TJC)

A good idea regardless of accreditation surveys! It’s all about patient safety

Centers for Medicare and Medicaid Services- CMS

Requires: Licensed, qualified IC person Written Infection Control Plan Which IC standards are being followed-

CDC (various), AORN, specialty, etc. Surveillance plan for infections Method of notifying DOH of reportable dz Education of staff in infection control

CMS, con’t.

Hand hygiene- wash or alcohol-based hand sanitizer, appropriate times

Use of gloves, other personal protective equip. Needle and medication safety: One needle, one

syringe, one patient, one time Single dose vials are single patient use Proper placement & use of sharps containers Sterilization & disinfection Environmental cleaning Point of care testing devices (blood glucose)

CMS, con’t.

Goals of an Infection Prevention and Control Program

Protect patients Protect workers Ensure compliance with infection

prevention and control regulations and other requirements, guidelines and recommendations

Promote “zero tolerance” for infections

Elements of the Infection Surveillance, Prevention & Control Program

1. Risk Assessment based on services provided, locale, population

2. Written Infection Prevention and Control Plan

3. Authority Statement4. Infection Control Service description5. Surveillance Plan

6. Goals and Measurable Objectives 7. Prevention & Control Strategies8. Communication and Reporting9. Emergency Management & Planning10. Education11. Evaluation of Program Effectiveness

Elements, continued

◊ Provides a basis for infection prevention activities and annual surveillance plan

◊ Identify at-risk populations in your facility- high volume, high risk, or problem-prone procedures

◊Assist in focusing surveillance efforts◊ Meet regulatory and other requirements

Facility Risk Assessment

Facility Risk Assessment

Epidemiologic principles to address◊ Volumes◊ Populations served◊ General and specialty services◊ Staff◊ Surveillance data◊ Geographic location and size◊ Epidemiologically important organisms

Assessment Summary◊ Who is at risk for infection◊ What types of infections◊ Recommendations to reduce risks

Facility Risk Assessment

Surveillance Plan

Surveillance methodology – how Surveillance indicators/events - what

◊ Risk assessment - why◊ Reasons for selecting indicators◊ Committee/leadership recommendations◊ New services, procedures, treatments

Comparative databases used Outbreak identification and response

Authority Statement

Example: The Board of Directors (Medical Director/Quality Committee) authorizes and supports the Director (Manager/etc.) of Infection Prevention to institute appropriate infection control measures within the facility. This includes authority to employ whatever methods necessary when, in their judgment, there is a reasonable possibility of immediate danger to any patient(s), personnel or others in the facility.

Infection Prevention & Control Service

Composition◊ Based on organization size, type, services,

needs, regulations & requirements◊ Personnel: number, qualifications, core

competencies, (office) location, hours◊ Medical Director/Epidemiologist/ID consultant

Leadership support Authority Reporting structure, other responsibilities

Identify & prioritize goals ◊ Based on risk assessment◊ Team effort & leadership approval

Goals should address at least: ◊ Limiting acquisition & transmission of pathogens◊ Limiting unprotected exposure to pathogens◊ Enhancing hand hygiene◊ Minimizing risk associated with procedures, devices

& equipment Develop measurable objective(s)

Goals & Objectives

Program Goals

Provide cost-effective program

◊ Healthcare Associated Infections = increased cost

◊ Infection Control programs = decreased cost

Limited reimbursement from CMS for preventable harm, also other payers

Prevention & Control Strategies

Identify prevention & control strategies Base on risk for transmission, care

setting, diseases in community Hand hygiene program Minimize risk associated with

procedures, devices, equipment

Communication & Reporting

Communication systems◊ Internal◊ External

Reports◊ What is reported◊ How it is reported (written, verbal)◊ Who receives the information◊ How often

Education

Education & training for◊ Health care providers, ancillary staff

New employee orientation, competency evaluations Annual and as needed infection control education

◊ Leaders◊ Infection Prevention and Control personnel

List offerings for the year – Plan a calendar

Emergency Management & Planning

Must involve collaboration◊ Internal◊ External (local emergency mgmt, health dept.)

Plan for◊ Recognition◊ Response (including influx of infectious pts.)◊ Containment◊ Communication (internal & external)

Evaluation of Program Effectiveness

Evaluate goals & program, ability to meetMeasure success or failure, why

◊ Rate reduction- highlight accomplishments!◊ Processes improved/Compliance improved

Infection Control Program resources◊ Personnel ◊ Non-personnel (computers, clerical support)

CollaborateEstablish new goals and objectives

The written Plan documents the existence of your IC Program

The Plan should incorporate all the elements required or included in your program

Reviewed and updated as things change, at least annually

IC Program vs. Written IC Plan

Tips for Developing Written Plan

Identify regulations & requirements Identify guidelines you will use Develop outline of Infection

Prevention and Control program Can use the examples given Network with others Consider incorporating your plan

into your annual report

Demonstrate collaboration throughout plan◊ Leaders, managers, caregivers & others ◊ Collaborate in program development,

implementation, evaluation, and assessment of resources

Assign responsibility for annual reviewInclude the essential elementsDistribute your plan widely

Tips, con’t.

Single most important procedure for preventing

healthcare-associated (nosocomial) infections

Underwood MA. APIC Text 2005

CDC Guideline for Hand Hygiene in Healthcare Settings, 2002http://www.cdc.gov/handhygiene/

Hand Hygiene

DefinitionsAntiseptic – antimicrobial substances (e.g. alcohol, CHG, triclosan) applied to the skin to reduce microbial flora

Alcohol-based hand rub – alcohol-containing preparation applied to the hands to reduce the number of viable microorganisms

Antimicrobial soap – detergent containing antiseptic agent

Waterless antiseptic agent – an antiseptic agent that does not require use of exogenous water

A 24-year-old man who had quadriplegia due to a traumatic spinal cord injury was found on routine surveillance cultures to have methicillin-resistant Staphylococcus aureus (MRSA) colonization of his anterior nares. He had no history of MRSA infection or colonization. To assess the potential implications of the patient's MRSA carriage for infection control, an imprint of a health care worker's ungloved hand was obtained for culture after the worker had performed an abdominal examination of the patient. The MRSA colonies grown from this handprint on the plate (CHROMagar Staph aureus), which contained 6 µg of cefoxitin per milliliter to inhibit methicillin-susceptible S. aureus, are pink and show the outline of the worker's fingers and thumb (Panel A). With the use of a polymerase-chain-reaction assay, the mecA gene, which confers methicillin resistance, was amplified from nares and imprint isolates. After the worker's hand had been cleaned with alcohol foam, another hand imprint was obtained, and the resulting culture was negative for MRSA (Panel B). These images illustrate the critical importance of hand hygiene in caring for patients, including those not known to carry antibiotic-resistant pathogens. New England Journal of Medicine

Why we use hand sanitizers

Opportunities for Hand Hygiene

1. Before entering patient room2. Before touching patient3. Before donning gloves4. Before handling meds, linen, clean supplies5. Between dirty and clean tasks6. After touching patient or their environment7. After handling soiled linen, dressings, etc.8. On removing gloves9. On leaving the room

Surgical Hand Antisepsis

State of the science: waterless surgical scrub solutions

1. Alcohol-based surgical hand-scrub Prewash hands and forearms with non-antimicrobial soap,

dry, then apply per manufacturer's instructions

2. Antiseptic surgical hand-scrubChlorhexidine (CHG) & Povidone Iodine (PVI) most

common

Artificial Nails

HCWs more likely to harbor gram negative pathogens on their fingertips

Outbreak of Pseudomonas aeruginosa in NICU attributed to artificial fingernails

Artificial fingernails epidemiologically implicated in several other outbreaks

Do not wear artificial fingernails or extenders when having direct contact with patients at high risk (e.g., those in intensive-care units or operating rooms) (IA)

Jewelry

◊ Skin underneath rings is more heavily colonized than comparable areas of skin on fingers without rings

◊ Study: 40% of nurses harbored gram-negative bacilli (e.g., E. cloacae, Klebsiella, and Acinetobacter) on skin under rings & certain nurses carried the same organism under their rings for several months

◊ In a more recent study involving >60 intensive care unit nurses, multivariable analysis revealed that rings were the only substantial risk factor for carriage of gram-negative bacilli and S. aureus and that the concentration of organisms recovered correlated with the number of rings worn

◊ Rings are not appropriate in the OR

◊ Earrings/necklaces must be covered in OR

CDC Guideline for Hand Hygiene in Healthcare Settings, 2002

Safe Injection, Infusion and Medication Vial Practices in

Healthcare

Maintaining Sterility

Perform hand hygiene before accessing and preparing medications

Disinfect (scrub) all vial tops & IV ports/hubs, locks with alcohol for 15 seconds before accessing (includes needleless systems) ◊ Let dry 15 seconds

A needle should never be left inserted into a medication vial septum for multiple uses◊ This provides a direct route for microorganisms to enter the vial

and contaminate the fluid

Use 5 micron filter needle for ampule

Maintaining Sterility

A new sterile needle and syringe used for each injection and each entry into vial

Do not use bags or bottles of intravenous solution as a common source of supply for more than one patient

Leftover parenteral medications should never be pooled for later administration

Single-use medication vials (e.g., propofol) should never be used for more than one patient

Assign multi-dose vials to a single patient whenever possible

IV Solutions

Sanitize hands before any contact with IV tubing or bag handling or change

Keep IV bags in plastic overwrap until ready for use (if out, date & discard in 30 days)

Begin administration within one hour of spiking IV bag/bottle (USP 797) or a soon as possible (APIC)-otherwise discard bag

IV Solution & Syringe Labeling

NEVER set an unlabeled syringe down or leave it unattended

NEVER administer a medication from an unlabeled syringe that you did not draw up & have control of from time drawn up to time given

NEVER draw up an oral or topical liquid into an injection syringe

Expiration

Discard medications upon expiration or any time there are concerns regarding the sterility

Date multidose vials when first entered & discard at 28 days or manufacturer’s expiration date, whichever is first

◊ Discard unopened vials at manufacturer’s expiration date

◊ Discard opened single dose vial/ampule discarded immediately after use on patient

◊ Discard prepared syringes at end of procedure-do not save for next case

http://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html

Irrigating Solutions

Best if irrigation solutions are discarded between patients

Warming irrigation solutions:

◊ T max <113°F, lower (104°) if IV fluids included (record temp daily)

◊ NEVER warm in microwave (any pt care item!)

Medication containing irrigations: obtain from Pharmacy - single patient use

Eye Drops, Ointments, Ear Drops

Hand hygiene before & after

Glove if contact with mucous membranes anticipated

Administer all eye & ear products using “no touch” technique to prevent contamination

If break in technique discard the container ASAP

Prefer single patient use

Topicals

◊ Sanitize hands◊ Prevent contamination of bulk

containers; use smallest available ◊ Small size can be dedicated to

single patient and then discarded◊ Remove desired amount with a

sterile applicator or tongue blade (no double-dipping) or squeeze onto a sterile gauze in a clean area

Cleaning, Disinfection, Sterilization

Risks in Invasive Procedures Both Inside and Outside the Traditional OR

Improper environmentInadequate cleaning, disinfection, and sterilization

◊ Staff not trained adequately◊ Antiquated equipment◊ Borrowed equipment◊ Improper use of equipment◊ Compromised cleaning procedures

Definitions

Cleaning: removal of all soil from objects/surfacesDecontamination: removal of all pathogenic microorganisms from objects to ensure they are safe to handle

Disinfection: elimination of many or all pathogenic organisms with the exception of bacterial spores

Sterilization: complete elimination, destruction of all microbial life

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

CLEANING

Cleaning

Defined as the physical removal of all visible soil, dust, and other foreign materials

Effective cleaning will reduce microbial contamination on environmental surfaces & equipment

Cleaning is the first and most important step before disinfection or sterilization can occur

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Presoaking

Prevents soils & proteins from drying on the instruments

Softens soils and assists with removal Prevents biofilm development Presoaking the instruments should ideally

occur immediately following the surgical procedure

Sprays, foams, availableAAMI ST79 2010; 7.4.1 p. 53

Enzymatic Detergents

Detergents are defined as substances capable of dislodging, removing and dispersing solid or liquid soils from a surface being cleaned

Enzymatic detergents usually consist of a detergent base with a neutral pH to which one or more enzymes and a surfactant is added

AAMI ST79, 2010, 7.5.2, p.55

Manual Cleaning

Follows presoaking Instruments washed submerged under water

to prevent potential exposure to microorganisms through aerosolization

Use a basket to lift out sharp items Staff must wear PPE including eye and face

protection Some endoscope washers may allow you to

eliminate manual cleaning

AAMI ST 79, 2010, 2.17, p.8

Ultrasonics for Delicate Instruments (e.g. eye instruments)

Effectiveness is based on cavitation: sonic waves generate minute bubbles on instrument surface

Bubbles then expand, become unstable, then collapse or implode

Implosion generates very localized vacuum areas that literally dislodges/sucks off the soil

Must clean machine per instructions AAMI ST79, 2010, 7.5.3.3, p. 57

DISINFECTION

Washer Disinfectors

Mechanically cleans instruments using a spray action called impingement ◊ Impingement is the water force making

contact with the instrument Several cycle processes; final step is

heated air drying Render instruments safe to handle

Spaulding Classification for Medical Devices

In 1972, Dr. Earl Spaulding developed a system for classifying medical instrumentation and equipment

◊ Non-critical – devices that touch intact skin, environmental surfaces – LOW LEVEL DISINFECTION

◊ Semi-critical – devices in contact with intact mucous membranes or skin that is not intact – HIGH LEVEL DISINFECTION

◊ Critical - (high risk) devices enter sterile tissue or bloodstream – STERILIZATION

APIC Text, 2009, p. 21-1-5

Device classification Examples Spaulding process classification

EPA Product Classification

Critical (enters sterile tissue or vascular system)

Implants, scalpels, needles, other surg. Instruments

Sterilization-sporicidal chemical; prolonged contact

Sterilant/disinfectant

Semi critical (touches mucous membranes)

Flexible endoscopes, laryngoscopes, ET tubes, vaginal specula

High level disinfection-sporicidal chemical; short contact

Sterilant/disinfectant

Hydrotherapy tanks

Intermediate level disinfection

Hospital disinfectant with label claim for tuberculocidalactivity

Non critical (touches intact skin)

Stethoscopes, tabletops, bedrails, blood pressure cuffs

Low level disinfection

Hospital disinfectant without label claim for tuberculocidal activity

Low Level Disinfection

Kills most bacteria, some viruses, some fungi Appropriate for non critical medical devices

and environmental surfaces Quaternary ammonium compounds (Quats)

are low level disinfectants ◊ Many quats are effective against TB and Hepatitis B

OK for use on blood spills and in OR environment

CDC Guideline for Disinfection & Sterilization in Healthcare Facilities, 2008

Environmental Cleaning and Disinfection

Have a written procedure for cleaning ALL environmental surfaces and equipment

◊ What, who, when, how◊ EPA-registered hospital disinfectant/detergent◊ Pop-up wipes very handy for small surfaces◊ Spray bottles discouraged, use nozzle top◊ Use original containers or manufacturer's label

APIC Text, 2009, Ch 100

Intermediate Level Disinfectants

Kills Mycobacterium tuberculosis, vegetative bacteria (e.g. Staphylococcus aureus), most viruses & fungi

Most phenolic disinfectants are classified as intermediate level

Appropriate for hard surfaces, floors, non-critical medical devices

Phenolic disinfectants are used cautiously where there are infants

APIC Text, 2009, Ch 100

High-Level Disinfection

A process (usually liquid chemicals or wet pasteurization) that eliminates:

◊ Many or all pathogenic microorganisms on inanimate objects

◊ Except large numbers of bacterial spores

◊ Short exposure times (<30 minutes)

CDC Guideline for Disinfection & Sterilization in Healthcare Facilities, 2008

High-Level Disinfection

Any instrument that will touch mucous membranes or non-intact skin

◊ Flexible endoscopes◊ Ultrasound probes, vaginal and anal, used with

sheath◊ Brushes used to clean instruments for HLD◊ Laryngoscope blades◊ Vaginal specula & related equipment◊ Diaphragm fitting rings

APIC Text 2009, p.21-6.

High Level Disinfection

Endoscopes- GI, GU, can’t tolerate high heat Sometimes for arthroscopes, laparoscopes

◊ Large studies of HLD arthroscopes have shown no increased risk of infection compared to sterilized arthroscopes

Follow label directions for soak time, temperature, use life, shelf life, product restrictions◊ No OPA for urology scopes per label on some OPA

products Use in well-ventilated area, wear PPE Many HLD products are similar: compare NEVER use HLD for environmental cleaning!

APIC Text 2009, p.21-3.

FDA-Approved Agents for Chemical High-Level Disinfection

Use for temperature-sensitive devices◊ Glutaraldehyde (> 2.0%) Cidex, Metricide, etc.*◊ Ortho-phthalaldehyde – OPA (0.55%) many brands◊ Hydrogen peroxide-HP (7.5%) Sporox◊ Peracetic acid-PA (0.2%) Steris ◊ HP (1.0%) and PA (0.08%) Peract◊ HP (7.5%) and PA (0.23%) Endospore (no test strips!)◊ Glutaraldehyde (1.12%) and Phenol/phenate (1.93%)

Sporicidin◊ 2% Activated Hydrogen Peroxide (Resert XL)

*Brand names used for illustration only, no endorsement is implied.

APIC Text 2009, p.21-3.

High-Level Disinfection

Glutaraldehyde and Ortho-phthalaldehyde – OPA◊ Various formulations and brands

Ready to use or requires activation (mixing) 14, 28 and 72 day formulations (maximum use days)

◊ Must use test strips to assess concentration prior to each use Minimum Effective Concentration (MEC) specific to each product

◊ Product must be rinsed thoroughly Sterile or potable water (dependent upon intended use of

instrument)

◊ Maintain log ◊ Must be neutralized for disposal (Glycine)

HLD Flexible Scopes

Immediately: wet wipe down outside of scope Take to soiled utility room (cart or tray, “enclosed”) Leak test (if fails, stop and send scope for repair) Initiate cleaning process- enzymatic soak Scrub and flush all channels, ports, valves, etc. Rinse, rough dry Immerse in HLD for product label-designated time, flush

and fill all channels to prevent air bubbles Rinse x 3, rinse channels with alcohol, blow dry Hang vertically to store, closed cabinet preferred

APIC Text 2009, p.21-3.

Automated Endoscope Reprocessors (AERs)

Perform some or all of the functions: leak testing, cleaning, disinfection, alcohol rinse and air drying of scopes

MUST ensure all lumens are properly connected to the system

APIC Text 2009, p.21-6.

Minimum Effective Concentration (MEC) Test Strips

Dilution of chemical occurs during routine use Test strips for monitoring the MEC, specific to

each product; test prior to each use, log Do not use test strips beyond expiration date QC test & document when opening a new bottle;

refer to manufacturer’s protocol

AORN Perioperative Standards & Recommended Practices, 2012, p. 489

High Level Disinfectant LogTray/Equipment

DateProcessed

Solution Expiration Date

Test StripExpiration Date

MEC Test Result(+ Pass or - Fail)

Solution Temperature

Solution Soak Time

Initials

Test Strip Example

- Fail + Pass

IMPORTANT!Solution must be discarded by expiration date, EVEN when MEC test passes

Cleaning/Disinfection in Endoscopy

Key Infection Prevention Interventions for cleaning and processing endoscopes

◊ Keep the scope moist – enzymatic soak◊ Transport in covered container◊ Consistent and complete cleaning of all channels◊ Manual cleaning includes

Valves Channels Connectors All detachable parts Brushes

Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes, 2011SGNA published updated guidance 9.12

◊ Leak testing and scope inspection◊ Processing: Per manufacturer

ChemicalAutomated endoscope washer-

disinfectorUse alcohol for final rinse, blow air

◊ Hang to dry (vented cabinet designed for hanging and storage of scopes)

◊ Do not store in case!

Cleaning/Disinfection in Endoscopy Setting (2)

Cleaning/Disinfection in Endoscopy Setting (3)

Documentation log◊ Patient name◊ Type of scope - Serial number ◊ Date and time of processing◊ Enzymatic soak time if manual◊ Chemical indicator results◊ Machine – bay number◊ Soak time if manual◊ Soak temperature◊ Attach print-out if available

ENDOSCOPY REPROCESSING LOG

Today’s Date: ___________________ Results Of Pre-Process Test:___________

Disinfectant: ____________________ Expiration Date Of Test Strips:__________

Activation Date: _________________

PatientName

Processor #

Load # Scope Leak Test

CleaningTime

SoakTime

Soak temp

Rinse Alcohol Purge

Initials

Competency, Process Monitoring

Training of ALL staff responsible for cleaning instruments, scopes, equipment (vacations?)

Post the procedure in work area Ensure proper equipment, PPE, supplies

available Competency evaluation initially & at least

annually Maintain training records Periodic visual monitoring of practice Consider microbiological monitoring if indicated

AAMI ST79 2010, 4.2, p. 37http://www.unc.edu/depts/spice/dis/Endoscope.html

STERILIZATION

Types of Sterilizers

Thermal (Heat)◊ Moist (Tabletop or large; Gravity, & High Speed

Vacuum)◊ DryChemical◊ ETO (ethylene oxide, “gas”)◊ Other chemicals- H2O2 gas plasma (Sterrad);

Steris◊ Ozone- commercial use◊ Radiation- commercial use

Example of a tabletop steam autoclave.

CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 59

Steam Gravity Sterilization

Low cost, quick turnover, no toxic chemicals, accommodates large loads

Steam enters the chamber by gravity & displaces air (so steam can penetrate load)

Takes longer for steam to reach required temperature

May not penetrate complex instruments

CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 59-60

Steam Pre-Vacuum or High Speed Vacuum, Pulse Vacuum

Low cost, quick turnover, no toxic chemicals, accommodates large loads

Air is removed (so steam can penetrate load) by a pump before steam at an elevated temperature is rapidly introduced, then rapidly removed at end to facilitate drying

Will penetrate complex instruments

CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 59

Mechanical convection – more efficient and temperature is more uniform

340°F for 60 minutes, dental 320°F for 2 hours Used for powders and oils that can tolerate

high temperatures See AAMI ST40

Dry Heat Sterilization

AAMI ST79, 2010, 8.5.8, p. 81CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 68

Ethylene oxide (EtO/EO); Used for heat & moisture sensitive devices Lengthy aeration time must follow each cycle to

allow removal of harmful residuals before opening chamber doors

EtO/EO is associated with human tumors Alarms, ventilation and training of staff promote

safe use of this agent

Low Temperature Sterilization

CDC Guideline for Disinfection & Sterilization in Healthcare Settings , 2008, p. 61

Hydrogen Peroxide Gas Plasma Sterilizer

CDC Guideline for Disinfection & Sterilization in Healthcare Settings , 2008, p. 61

Packaging for Sterilization

Use the correct wrapper for the type of sterilization to be performed, items to be packaged

Wrappers must have a 510k that specifies what it can be used for (ETO, steam, etc.)

Same for peel packs

AORN Standards & Recommended Practices, 2012, p. 537-545

Peracetic Acid Sterilizer

Steris 1gone byFeb. 2, 2012

Steris 1eFDA Approved

Definition:◊ AAMI: “process designed for the steam sterilization of

patient care items for immediate use”◊ AORN: “should be used only when there is insufficient time

to sterilize the item by the preferred wrapped or container method”

Not recommended outside of the ambulatory surgical center where it can be used in a controlled manner

Should never be used as a substitute for sufficient inventory

Flash Sterilization- Now Called “Immediate Use Steam Sterilization”

AAMI ST79, 2010, 8.8, p. 86

Immediate Use Sterilization

Acceptable only for items: AAMI guidelines for implants AORN guidelines for implants Single instruments only (not trays) Urgently needed Cleaned well Used close to point of sterilization Adequately covered or protected from

contamination Use mechanical, chemical, and biological

indicators

AORN Standards and Recommended Practices, 2012, p.550-552

Considerations: Risk of burns from hot instruments Recontamination of instruments during

transport Keep logs of all immediate using (process

surveillance) Monitor number of times used, what

procedures, and why – use as dept PI Monitor staff training and performance

Immediate Use Sterilization

AORN Standards and Recommended Practices, 2012, p.550-553

Quality Assurance for Steam Sterilization

Critical Parameters for each load◊ Steam◊ Temperature◊ Pressure◊ Time

AAMI ST79, 2010, p. 97-102

Sterilization Indicators

Class I – External, time, temp, pressure indicator, says item went through autoclave (tape)

Class II – Bowie Dick, checks for air removalClass III – Internal, time & temp, rarely used todayClass IV – Internal, reacts to two or more parameters, rarely used today

Class V – Integrators, melted chemical pellet, reacts to all parameters, all steam cycles

Class VI – Emulating indicators, cycle specificBiological – gold standard, shows kill of organisms

AORN Standards and Recommended Practices, 2012, p. 564-565

Examples of Bowie Dick Tests (for prevac sterilizers only)

Sterilization Monitoring:Mechanical Indicators

Cycle time, temperature, & pressure is displayed on the sterilizer gauges with each instrument load

Printout or graph documents these indicators

If these fail, load is no good.

Sterilization Monitoring: Chemical Indicators (CI)

The CI is a process indicator that signals the item has been exposed to sterilization process (temperature, time, etc.)

A CI is affixed to outside of package & used with every load

An indicator is also placed inside the pack to verify steam penetration

Peel-packs have a single indicator If these fail, load is no good

Sterilization Monitoring: Biological Indicators (BI)

Closest to being the ideal monitor & measure of effectiveness by challenging the sterilization process against a resistant spore (Bacillus sp.)

Use BI daily if sterilizer is used frequently Also, use a BI for every implant & EtO run Policy for positive tests- who to notify, id

instruments used, recall? “IC Communication” report

Biological Indicators (BI) Compare capsules for color

change at regular intervals Length varies with the product;

rapid readout 1-3 hours, or 24 hours

Read and record results Positive test = sterilization

process has failed due to improperly processed load, failure to meet temperature or exposure parameters, mechanical problems, etc.

Yellow = Positive Purple = Negative

Documentation: Note the Control is positive the Biological is negative

Positive BIs

Remove sterilizer from service until problem resolved Consider recalling packs processed since last “good”

load Check sterilizer records or logs to see if all other

critical parameters were met Repeat the BI in 3 separate loads

◊ If all are negative and critical parameters are met, place it back into use

◊ If one or more continue to be positive Have machine serviced Repeat BI using a different manufacturer or lot of indicators

AAMI ST79, 2010, 10.7.5, p. 114

Storage of Clean/Sterile Supplies

Store at least◊ 8-10” from the floor

◊ 18” from the ceiling

◊ 2” from outside wallsSolid bottom shelfClosed cabinetsAvoid overfilled drawersNO RUBBER BANDS!

AORN Standards & Recommended Practices, 2012, p. 559

Time-Related vs. Event-Related Sterility

Historically, sterile items had an expiration date… yet items don’t suddenly convert from sterile to non-sterile

Event-related sterility states the product does not have an expiration date providing the package is intact (e.g. wrapping intact, package is not wet, etc.)

Sterility is event related, not time related!

AORN Standards & Recommended Practices, 2012, p. 560

Reuse of Single Use Devices (SUDs) Manufacturers cite “single use only” on many of their

products (e.g. cardiac caths, orthopedic bits/blades, DVT sleeves, etc.)

Re-use of these products can result in significant financial savings

Concern with the risk of infection and injury when the devices are re-used

Must consider regulatory, medical, ethical, legal, & economic issues before proceeding forward

3rd party reprocessing acceptable when premarket requirements are met (FDA 510(k)) (amdr.org)

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/default.htm

Vendor-Supplied EquipmentVendor

◊ Must wear appropriate attire in OR◊ Name badge; should meet employee criteria for

medical screening and immunization◊ Bring written cleaning, disinfection, sterilization

instructions from manufacturer of deviceEquipment

◊ Must be delivered to the CS decon for cleaning and sterilization (with instructions)

◊ Allow adequate time for processing◊ Record “borrowed” equipment contents, vendor

name, patient or case number involved, surgeon name, date and time, keep a log

AORN Standards & Recommended Practices, 2012, p. 558

CMS and accreditation requirements are all about patient safetyRisk assessment, written plan, evaluation of program, documentHand hygiene, hand hygiene…Safe injection practicesCleaning, disinfection, sterilizationEnvironmental cleaning

Summary

Thank You!

marcia.patrickip@gmail.com