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I am hoping you could provide some direct guidance from the CDC on multi-parameter pouches. We include at least one package with a strip in every load, and don’t release the load until that has been visually inspected.

The CDC Division of Oral Health maintains a webpage for sterilization monitoring which can be accessed at this link:
https://www.cdc.gov/oralhealth/infectioncontrol/faqs/monitoring.html 1

This webpage states in part:

Sterilization procedures should be monitored using biological, mechanical, and chemical indicators. Biological indicators, or spore tests, are the most accepted means of monitoring sterilization because they assess the sterilization process directly by killing known highly resistant microorganisms (e.g., Geobacillus or Bacillus species). However, because spore tests are only done weekly and the results are usually not obtained immediately, mechanical and chemical monitoring should also be done. 1

And,

A chemical indicator should be used inside every package to verify that the sterilizing agent has penetrated the package and reached the instruments inside. If the internal chemical indicator is not visible from the outside of the package, an external indicator should also be used. External indicators should be inspected immediately when removing packages from the sterilizer; if the appropriate color change did not occur, do not use the instruments. Chemical indicators help to differentiate between processed and unprocessed items, eliminating the possibility of using instruments that have not been sterilized. 1

As a matter of policy, Ask OSAP does not provide technical support for specific products. If you have questions about the use of a specific pouch product, it is recommended that you contact the manufacturer of that product directly for further information about the product’s validated instructions for use (IFU).

Resources

1) US Centers for Disease Control and Prevention. Sterilization – Monitoring. https://www.cdc.gov/oralhealth/infectioncontrol/faqs/monitoring.html Accessed on March 9, 2018.

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Last Updated on Thursday, July 08, 2021 04:32 PM