3M Steri-Vac GS Series - 13.2. Biological Indicators and Process Challenge Devices

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3M
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Steri-Vac
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Sterilizer /Aerator GSSeries – Operator’sManual
13.2. Biological Indicators and Process ChallengeDevices
CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilizationprocedures,
always use chemical indicators and biological indicators for monitoring the performance of sterilization cycles as described in this manual. Always use chemical indicators and biological
indicators per the device manufacturer’s instructions for use(IFU).
Biological indicators (BIs) consist of viable spores in or on a carrier, sometimes (as in the case of self-contained BIs) accompanied by incubation media. BIs provide the only direct measure of
the lethality of the sterilization process. BIs must be incubated for various periods of time (depending on the specific product) until it is determined whether the microorganisms grow (i.e. they
survived the sterilization process) or fail to grow (i.e. they were killed by the sterilizationprocess).
BIs are intended to demonstrate whether conditions in the sterilizer chamber were adequate to achieve sterilization. A negative BI does not prove that all items in the load are sterile or that all
items were all exposed to adequate sterilization conditions. All BIs should be used in accordance with the biological indicator manufacturer’sinstructions.
For routine monitoring of the 3M™Steri-Vac™ Sterilizer/Aerator GS Series EO sterilization process, use biological indicators such as the 3M™ Attest™ Biological Indicators forEO.
3M™ Attest™ Biological indicators forEO:
• comply with applicable clauses of ANSI/AAMI/ISO 11138-1:2006and ANSI/AAMI/ISO11138-2:2006
• contain spores of Bacillusatrophaeus
• should be placed within an appropriate process challenge device(PCD)
A process challenge device (PCD) (also known as a Test Pack) is a device used to assess the effective performance of a sterilization process by providing a challenge to the process that is equal
to or greater than the challenge posed by the most difficult item or set routinelyprocessed.
A routine BI PCD (or Test Pack) per ANSI/AAMI ST41, or an equivalent commercially available BI PCD such as the 3M™ Attest™ Biological Indicator Test Pack for EO or 3M™ Attest™ Rapid
Readout Biological Indicator Test Pack for EO , is used for routine biological monitoring of ethylene oxide (EO) sterilization cycles. A routine BI PCD is also used in sterilizer testing after process
failures, malfunction, or majorrepair.
A routine BI PCD should be used in every load. The routine BI PCD should be placed in the center of theload.
Each load containing implantable devices should be monitored and quarantined until the results of the BI testing areavailable.
The BI challenge test pack per ANSI/AAMI ST41should be used for sterilizer qualification testing after sterilizer installation, relocation, or majorredesign.
BIs should also be used for periodic product quality assurance testing of representative samples of actual products beingsterilized.
Use a positive control each day a BI is processed. This helpsensure:
• Correct incubation temperatures aremet.
• Viability of the spores has not been altered due to improper storage temperature, humidity, or proximity tochemicals.
• Capability of media to promotegrowth.
• Proper functioning of the BIincubator.
Failure of the positive control test may invalidate the processed indicator results. Refer to the instructions for use for BIs for additionalinformation.
13.3. ChemicalIndicators
CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilizationprocedures,
always use chemical indicators and biological indicators for monitoring the performance of sterilization cycles as described in this Operator’s Manual. Always use chemical indicators and
biological indicators per the device manufacturer’s instructions for use(IFU).
13.3.1. External ChemicalIndicator
The purpose of an external chemical indicator (CI), such as 3M™ Comply™ EO Indicator Tape, is to differentiate between processed and unprocessed items, not to establish whether the
parameters for adequate sterilization weremet.
Distinguish between processed and unprocessed items by affixing a process indicator, in the form of sterilizer indictor tape, an indicating label, or an indicating printed legend to each assembled
package or rigid sterilization container system intended for sterilization.
An external indicator, such as 3M™ Comply™ EO Indicator Tape, should be used on all packages except for packages that allow visual inspection of an internal indicator, such as those with
paper–plastic packaging. The external CI should visually denote that the package has been exposed to physical conditions present in the EO sterilizer. The indicator should be examined after
aeration and also before use of the item to verify that the item has been exposed to a sterilizationprocess.