Vaporized Hydrogen Peroxide Recognized by FDA for Sterilization in Lieu of EtO

Vaporized hydrogen peroxide (VHP) is now an established method of sterilization for medical devices, the FDA said, and can be used in place of ethylene oxide (EtO), which has been under fire for its potential to cause cancer.

The FDA has revised the final guidance, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,” to list VHP as an example of an Established Category A method of sterilization.

The update comes after months of public discussion of the potential effect of eliminating the use of EtO to sterilize nearly 50 percent – 20 billion items annually – of reusable medical devices. The Environmental Protection Agency (EPA) must complete its work on the final rule governing commercial sterilization EtO by March 1 following the government’s signature on a consent decree that settles a complaint against the EPA filed by multiple groups in December 2022.

Read the final guidance here.

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