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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
Chemical IndicatorsChemical Indicators
• 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 IndicatorsChemical Indicators
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..
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
Sterilization Process Sterilization Process MonitorsMonitors
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
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