managing sterilization process indicator failures · managing sterilization process monitor...

MANAGING STERILIZATION PROCESS MONITOR FAILURES

Joseph F. LeBouef, RST, CST, CRCST, CHL Regional Sterile Processing Educator, Kaiser Foundation

Health Plan of the Northwest

President, IAHCSMM Cascade Chapter

Why Monitor the Sterilization Process?

• Critical items contact normally sterile tissues of the body-items must be sterile

• You can’t see sterility

• You can’t reasonably verify or test sterility

• Sterility is a probability function, affected by:

• Human factors

• Equipment and utility issues

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Types of Sterilization Monitors

Physical • Mechanical charts, printouts or graphs

Chemical • Indicate exposure to sterilizing agent

Biological • Measure lethality of cycle

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Physical Monitors

Information provided:

• Whether or not the sterilizer

performed as instructed

• Parametric only

• Only measures at one location in

chamber

• No indication of whether sterilant

reached device or if lethality

was achieved

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Chemical Monitors (Indicators)

• Information provided: • Whether adequate sterilant concentration

and/or other critical variables required for sterilization occurred at specific location inside sterilizer chamber or processed package

• No measure of cycle lethality

• Both external and internal for each package

• 6 Classifications – not hierarchical

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Classification of Chemical Indicators

Class I: Process Indicators • React to 1 critical variable • Used to differentiate items that were

exposed from those that were not

Class II: Indicators for Use in Specific Tests • Special tests (Bowie-Dick/DART -

used to assess dynamic air removal sterilizer’s ability to remove air)

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Classification of Chemical Indicators

Class III: Single Variable Indicators • React to 1 critical variable • Indicates performance in relation

to at least 1 stated value • Not commonly used

Class IV: Multi-variable Indicators • React to at least 2 critical variables • May be used as internal pack

monitors

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Classification of Chemical Indicators

Class V: Integrating Indicators • React to ALL critical variables • Used as internal pack monitors • Performance must mimic biological

performance

Class VI: Emulating Indicators • React to ALL critical variables • Used as internal pack monitors • Performance does not mimic biological

performance • Cycle specific

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Placement of Chemical Indicators

AAMI: • Placed in area least accessible to sterilant

penetration

• For containers, refer to manufacturer’s written instructions

AORN: • For wrapped items: 1 in geographical center of

package, on each level if multiple levels

• For containerized items: placed in 2 opposing corners, on each level

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Biological Monitors (Indicators)

• Only monitor that directly measures cycle lethality • Steam, H2O2 and ozone processes use known quantities of highly resistant Geobacillus stearothermophilus spores • Specifically designed for particular modality employed • Sterilizers monitored on routine basis and

with ALL implantable devices • Steam: at least weekly, preferably daily • H2O2: at least daily • Ozone: every cycle

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Application of Biological Indicators

• Placed directly over drain, on lowest shelf of sterilization cart/rack

• Indicator must be specifically approved for use in the modality employed: • 250⁰ F gravity displacement air removal (example: 3M

1292 BROWN top BI) • 270⁰ F gravity displacement air removal (example: 3M

1291 BLUE top BI) • 270⁰ F dynamic (pre-vac) air removal (example: 3M

1292 BROWN top BI, possibly in a process challenge device)

• All modalities employed must be tested

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Application of BIs (Continued)

• Unprocessed BI used as control test to ensure viability of spores • Daily, and • With each new lot number of BI

• Implantable devices should not be released until BI results are known

• If emergency necessitates early release, an exception form should be used to communicate risk to provider

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Exception Form for Premature Release of Implantable Device/Tray

NOTE—In a documented emergency situation, implantable devices will be released from quarantine without the biological monitor result. This form should accompany the implant to the Operating Room. Operating

Room personnel should complete this form and return it to Central Service within 24 hours.

PLEASE COMPLETE ALL INFORMATION:

DATE: _______________________________ SHIFT: _____________________ TIME: __________ AM PM PERSON COMPLETING THIS REPORT IN CENTRAL SERVICE: _________________________________________

The following implantable devices/trays were prematurely released to the Operating Room: __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________

NAME OF OR PERSON REQUESTING PREMATURE RELEASE OF DEVICES: __________________________________________________________________________________________

OPERATING ROOM REPORT: PATIENT NAME: ____________________________________________________________________________ SURGEON NAME: ___________________________________________________________________________ TIME OF PROCEDURE: ____________________ AM PM DATE: ________________________________

REASON PREMATURE RELEASE WAS NEEDED: ____________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________

WHAT COULD HAVE PREVENTED PREMATURE RELEASE OF THIS DEVICE/TRAY? _________________________ __________________________________________________________________________________________ __________________________________________________________________________________________

NAME OF OR PERSON COMPLETING THIS REPORT: ________________________________________________ DATE REPORT COMPLETED: _____________ FORM RETURNED TO CENTRAL SERVICE ON: _______________

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When Monitors Indicate Failure

• Quarantine items/remove sterilizer from service

• If reason is apparent (incorrect cycle selected, sterilizer loaded improperly, etc.)

• Correct issue, repackage and reprocess items

• If reason is not apparent

• Recall all items processed since last negative biological test

• Any items used must be communicated to Infection Prevention & Control and to provider responsible for care of patient

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If Failure Results in Repair of a Sterilizer

Minor repair

• Routine monitors performed, then sterilizer released into service

Major repair

• Repairs that effect the basic performance of the sterilizer (chamber welding, major refitting of piping, software overhaul, etc.)

• Sterilizer must be requalified

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Steam Sterilizer Qualification

• Performed when a new sterilizer is installed, a sterilizer’s location is changed or it undergoes major repair

• 3 back-to-back biological indicators performed in an empty chamber

• 3 Bowie-Dick/DART tests performed back-to-back in an empty chamber

• Sterilizers quarantined until test results are obtained

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Questions?

Thank you!

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References

• ANSI/AAMI ST79:2010 & Amendment 1/Amendment 2

• AORN Perioperative Standards and Recommended Practices, 2011

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