Sterilization Monitoring April 2009

Monitoring the Sterilization Process

THETA CHAPTER May 09THETA CHAPTER May 09

Quality AssuranceQuality Assurance

Each Health Care Facility Each Health Care Facility

should have a system in place should have a system in place to provide quality patient care to provide quality patient care through the provision of sterile through the provision of sterile equipment and medical equipment and medical devices.devices.

Quality Assurance ProgramQuality Assurance Program

Should include:Should include:• Administrative ControlsAdministrative Controls• Chemical Indicator MonitoringChemical Indicator Monitoring• Biological Indicator MonitoringBiological Indicator Monitoring• Mechanical IndicatorsMechanical Indicators• Continuing EducationContinuing Education

Quality AssuranceQuality Assurance

CPD - Administrative ControlsCPD - Administrative Controls

– policies and procedurespolicies and procedures– continuous education, training and continuous education, training and

observation of employees observation of employees – maintain updated knowledge about maintain updated knowledge about

guidelines, current research and guidelines, current research and recommended practicesrecommended practices

– CPD designed to facilitate efficient CPD designed to facilitate efficient processing of patient care items processing of patient care items

Accepted Practice Accepted Practice GuidelinesGuidelines

CSACSA Canadian Standards Association Canadian Standards Association InternationalInternational

AAMIAAMI Association for the Advancement Association for the Advancement of Medical Instrumentationof Medical Instrumentation

ASHCSPASHCSP American Society for Healthcare American Society for Healthcare Central Service Professionals Central Service Professionals

AORNAORN Association of Operating Room Association of Operating Room NursesNurses

ORNACORNAC Operating Room Nurses Operating Room Nurses Association of CanadaAssociation of Canada

CDCCDC Centers for Disease Control and Centers for Disease Control and PreventionPrevention

LCDCLCDC Laboratory Centre for Disease Laboratory Centre for Disease ControlControl

Objectives of Monitoring Objectives of Monitoring the Sterilization Processthe Sterilization Process

• Assure high probability of absence Assure high probability of absence of microbes on processed itemsof microbes on processed items

• Detect failures as soon as possibleDetect failures as soon as possible• Remove medical devices involved in Remove medical devices involved in

failures before patient usefailures before patient use• Improve patient outcomesImprove patient outcomes• Control costsControl costs• Peace of mindPeace of mind

Methods of MonitoringMethods of Monitoring

1.1. Mechanical IndicatorsMechanical IndicatorsEquipment controlEquipment control

2.2. Chemical IndicatorsChemical IndicatorsExposure/Process controlExposure/Process control

Pack controlPack control

3.3. Biological IndicatorsBiological Indicators

Load controlLoad control

Sterilization Process Sterilization Process MonitorsMonitors

STERILITY STERILITY ASSURANCEASSURANCESTERILITY STERILITY

ASSURANCEASSURANCE

MECHANICALMECHANICAL

CHEMICALCHEMICAL

BIOLOGICALBIOLOGICAL

COMBINED COMBINED RESULTSRESULTS


Equipment Control Equipment Control

Mechanical Indicators show:Mechanical Indicators show:

• what is happening in the chamberwhat is happening in the chamber• whether conditions are being metwhether conditions are being met• cycle, time, temperature and cycle, time, temperature and

pressurepressure


Mechanical IndicatorsMechanical Indicators

Recording thermometer – circle graphRecording thermometer – circle graphComputer printouts – paper stripComputer printouts – paper stripGauges – jacket and chamber pressureGauges – jacket and chamber pressure

If conditions were not met:If conditions were not met:Consider load un-sterile and do not Consider load un-sterile and do not use sterilizer until the problem is use sterilizer until the problem is identifiedidentified


Equipment ControlEquipment Control

Mechanical IndicatorsMechanical Indicators

•monitor one location in sterilizermonitor one location in sterilizer•do not monitor each pack or traydo not monitor each pack or tray•do not indicate sterilitydo not indicate sterility


Exposure control / Pack controlExposure control / Pack control

Chemical Indicators (CI)Chemical Indicators (CI)

• monitor one or more of requirements -monitor one or more of requirements -time, temp, and sterilanttime, temp, and sterilant

• can be external and Internalcan be external and Internal• give instant resultsgive instant results• indicate proper conditions for indicate proper conditions for

sterilization were presentsterilization were present


Exposure ControlExposure Control

External Chemical IndicatorExternal Chemical Indicator• process indicator - autoclave tapeprocess indicator - autoclave tape• distinguishes processed from distinguishes processed from

unprocessed medical devicesunprocessed medical devices• secures packsecures pack• labels packlabels pack

If indicator did not change, do not useIf indicator did not change, do not use


Pack ControlPack Control

Internal Chemical IndicatorInternal Chemical Indicator

• inside each package, tray or containerinside each package, tray or container• paper strips or cardspaper strips or cards• validates sterilant penetrationvalidates sterilant penetration• colour change strip or moving front formatcolour change strip or moving front format• can measure all process parameters can measure all process parameters

(Integrators)(Integrators)

Chemical IndicatorsChemical Indicators


Pack ControlPack Control

Internal Chemical IndicatorInternal Chemical Indicator

Pack Control CI - Pack Control CI - advantagesadvantages• detects incorrect packagingdetects incorrect packaging• incorrect loadingincorrect loading• malfunction of sterilizermalfunction of sterilizer• easy to retrieve and readeasy to retrieve and read



• Do not tell you that spores are killedDo not tell you that spores are killed

• Do not tell you that item is sterile Do not tell you that item is sterile


Chemical Indicators cannotChemical Indicators cannot

replace Biological Indicatorsreplace Biological Indicators

based on accepted practicebased on accepted practice

guidelines and currentguidelines and current

scientific knowledgescientific knowledge

Sterilization Process Sterilization Process MonitoringMonitoring

All recommended practices All recommended practices state that both biological and state that both biological and chemical indicators shall be chemical indicators shall be used to monitor the used to monitor the sterilization processsterilization process..


Load ControlLoad Control

Biological IndicatorsBiological Indicators

Confirm the ability of the Confirm the ability of the sterilization process to kill sterilization process to kill microbial sporesmicrobial spores


Load ControlLoad Control

Biological Indicators Biological Indicators • large number of sporeslarge number of spores• Integrate all the parameters of the Integrate all the parameters of the

sterilization processsterilization process• Most critical test of the sterilization Most critical test of the sterilization

processprocess• CSA requires routine monitoring dailyCSA requires routine monitoring daily

Biological IndicatorsBiological Indicators

VialVial

SporeSporeStripStrip

AmpouleAmpoule

FilterFilter

CapCap

Steam SterilizersSteam Sterilizers

Routine Monitoring - SteamRoutine Monitoring - Steam

• Test pack – includes BI containingTest pack – includes BI containingBaBacillus stearothermophiluscillus stearothermophilus

• Performed daily and in every load Performed daily and in every load containing implantable devicecontaining implantable device

• Placement - near drain in fully Placement - near drain in fully loaded sterilizer loaded sterilizer

Ethylene Oxide Sterilizers Ethylene Oxide Sterilizers

Routine Monitoring – EORoutine Monitoring – EO

• EO Test pack – includes BI EO Test pack – includes BI containing containing Bacillus SubtilisBacillus Subtilis

• Performed every loadPerformed every load• Placement - centre of normally Placement - centre of normally

loaded sterilizerloaded sterilizer

Biological Indicator Biological Indicator Test PacksTest Packs


Bowie Dick Type Tests Bowie Dick Type Tests

•Detects entrapped air in Vacuum-Detects entrapped air in Vacuum-assisted sterilizers, not for Gravityassisted sterilizers, not for Gravity

•Measures steam penetrationMeasures steam penetration•Run dailyRun daily•Test packs – can be in-house or Test packs – can be in-house or commercially preparedcommercially prepared


Bowie Dick TestBowie Dick Test

•Run a warm-up cycle firstRun a warm-up cycle first•Place test pack in an empty Place test pack in an empty sterilizer over the drainsterilizer over the drain

•132C (270F) for 3.5 - 4 minutes 132C (270F) for 3.5 - 4 minutes •Uniform colour changeUniform colour change•Retain in recordsRetain in records


Bowie Dick Test resultsBowie Dick Test results

If colour change not uniformIf colour change not uniform • Repeat testRepeat test• Shut downShut down• Call repair personCall repair person• RetestRetest

If uniform colour changeIf uniform colour change• Use sterilizerUse sterilizer

Bowie Dick Test Bowie Dick Test

Unprocessed Processed

Bowie Dick Test PacksBowie Dick Test Packs

““It is a dangerous practice It is a dangerous practice simply to conclude, without simply to conclude, without investigation, that indicator investigation, that indicator giving warning is incorrect.”giving warning is incorrect.”

AAMI TIRAAMI TIR

Sterilization ProcessSterilization Process Routine MonitoringRoutine Monitoring

Chemical IndicatorChemical Indicator

Bowie Dick Type Bowie Dick Type TestTest

ExternalExternal

InternalInternal

CSA RecommendsCSA Recommends

– DailyDaily

– Each package, tray, Each package, tray, containercontainer

– Each package, tray, Each package, tray, containercontainer

Sterilization Process Sterilization Process Routine MonitoringRoutine Monitoring

Biological IndicatorBiological Indicator

SteamSteam

FlashFlash

Ethylene OxideEthylene Oxide

CSA RecommendsCSA Recommends

– Daily; every load with Daily; every load with an implantable device an implantable device

– Daily; every load with Daily; every load with

an implantable devicean implantable device

– Every LoadEvery Load

Installation & Repair Installation & Repair TestingTesting

Performed:Performed:– before sterilizer released for use before sterilizer released for use – after major repairs or relocationafter major repairs or relocation– after unexplained sterility failuresafter unexplained sterility failures– after changes in sterilant supply after changes in sterilant supply – annuallyannually

3 cycles using BI test pack – yielding 3 3 cycles using BI test pack – yielding 3 negative resultsnegative results

If vacuum – 3 cycles with Bowie-Dick If vacuum – 3 cycles with Bowie-Dick test packtest pack


Record KeepingRecord Keeping • Document all materials that have Document all materials that have

been processed and the results of been processed and the results of the sterilization process the sterilization process monitoringmonitoring

Record KeepingRecord Keeping

Product LabelingProduct Labeling

• lot or load control numberlot or load control number• processing dateprocessing date• sterilizer numbersterilizer number• cycle numbercycle number• Expiration statementExpiration statement

• event-relatedevent-related• time-relatedtime-related

Record KeepingRecord KeepingLoad RecordsLoad Records

• date and time of all cyclesdate and time of all cycles• exposure time and temperatureexposure time and temperature• load contentsload contents• initials of operatorinitials of operator• BI results, CI resultsBI results, CI results• Records of sterilizer maintenance, Records of sterilizer maintenance,

calibration, and repair calibration, and repair

Product RecallProduct Recall

Recall ProcedureRecall Procedure If positive BI:If positive BI:• review record, quarantine loadreview record, quarantine load• notify maintenance personnelnotify maintenance personnel• identify microorganism on + BIidentify microorganism on + BI

If contamination occurred, If contamination occurred, and record is OK, release loadand record is OK, release load

Product RecallProduct Recall

If microorganism is the spore, do If microorganism is the spore, do further testingfurther testing

• Follow hospital policyFollow hospital policy• Initiate recall and request Initiate recall and request

sterilizer service as neededsterilizer service as needed• Written recall orderWritten recall order• Written reportWritten report

Continuing EducationContinuing Education

Quality patient care Review CSA standards Know your hospital policies Ask questions; Keep learning Apply what you learn into

practice

Reference CSA Reference CSA StandardsStandards

CAN/CSA-Z11140-1-98 Sterilization of CAN/CSA-Z11140-1-98 Sterilization of Health Care Products - Chemical Health Care Products - Chemical Indicators - Part 1: General Indicators - Part 1: General Requirements (Adopted ISO 11140-Requirements (Adopted ISO 11140-1:1995) 1:1995)

CAN/CSA-Z314.2-01 Effective Sterilization CAN/CSA-Z314.2-01 Effective Sterilization in Health Care Facilities by the Ethylene in Health Care Facilities by the Ethylene Oxide ProcessOxide Process

CAN/CSA-Z314.3-01 Effective Sterilization CAN/CSA-Z314.3-01 Effective Sterilization in Health Care Facilities by the Steam in Health Care Facilities by the Steam ProcessProcess

Documents

Sterilization Monitoring April 2009