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FAQ: Are biological indicators viable for extended cycles?


Q:

I have heard that 3M™ Attest™ Rapid Readout Biological Indicator Test Packs should not be used to monitor extended steam sterilization cycles. Is this true?

A:

No. The package insert for the 3M™ Attest™ 41382 Rapid 5 Steam Plus Test Pack states the following:

"Use an Attest Rapid 5 Steam-Plus Test Pack to monitor loads containing fabric packs or wrapped metal instruments or hard goods run at 121°C (250°F) for 30 minutes in a gravity cycle, or 132°C (270°F) for 4 minutes in a vacuum assisted cycle."

A minimum cycle time is listed but a maximum cycle time is not specified. All biological indicator (BI) test packs on the market today are designed to be equivalent to the AAMI 16-towel test pack and have similar indications for use in their product package inserts.

Based on publicly available information, the FDA has not cleared a biological indicator process challenge device (BI PCD) that is specifically designed to monitor extended cycles. AAMI has a PCD Working Group comprised of representatives from device manufacturers, FDA, and end-users who are working to address this extended cycle issue.

Q: Does 3M have data showing that 3M™ Attest™ Rapid Readout Biological Indicators are able to withstand exposure to extended steam sterilization cycles and still perform properly to detect cycle failures?
A:

Yes. In response to the increased usage of extended steam sterilization cycle times in health care facilities, 3M completed a study with 3M™ Attest™ 1292 Rapid Readout Biological Indicators (BIs) that showed the media was unaffected by exposure to a 20 minute extended vacuum-assisted steam sterilization cycle and the BIs performed as designed.

Note: The 3M Attest Rapid 5 Steam Plus Test Pack contains the 3M Attest 1292 Rapid Readout Biological Indicator.

Attached please find the white paper titled "Effect of Extended Steam Sterilization Cycles on Self Contained Biological Indicators with Enzyme-based Early Readout" (PDF, 31.1 KB) by William Foltz. This is a summary of the study protocol and methodology used, and results show that the 3M Attest Rapid Readout Biological Indicator functions properly after exposure to extended cycle conditions.
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