FDA Endorses Vaporized Hydrogen Peroxide

FDA says it now considers vaporized hydrogen peroxide (VHP) to be an established sterilization method for medical devices. The agency has revised its final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to reflect VHP’s recognition for sterilization. The action is part of the agency’s efforts to reduce the use of ethylene oxide (EtO) where possible.

EtO is the most common sterilization method for medical devices in the U.S., according to an agency notice. “Since 2019, the FDA has promoted the development of alternatives to EtO and has implemented a number of programs and initiatives to support innovation in medical device sterilization,” it says. “This includes developing Sterilization Master File Pilot programs to support certain changes to sterilization processes, launching innovation challenges to encourage new strategies to reduce EtO emissions and the development of new sterilization methods or technologies and proactively engaging with industry to help advance innovative alternatives to EtO.”