FDA Deems Vaporized Hydrogen Peroxide an Established Method of Sterilization

The update is part of the FDA effort to reduce the use of ethylene oxide.

The U.S. Food and Drug Administration (FDA) announced that it now considers vaporized hydrogen peroxide (VHP) as an established method of sterilization for medical devices.

In what the agency called a recognition of its long-time effectiveness, it revised the final guidance on the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. As a result, VHP is now listed as an example of an Established Category A method of sterilization, facilitating VHP as a sterilization method for the device industry. The update is part of a broader effort by the FDA to reduce the use of ethylene oxide (EtO) and boost medical device supply chain resiliency. Currently, EtO is the most commonly used sterilization method in the U.S., applying to more than 20 billion devices sold in the U.S yearly (or 50% of all devices that require sterilization). 

“The FDA’s commitment is to protect public health, a critical mission in today’s complex medical device ecosystem,” said Suzanne Schwartz, MD, MBA, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, in a news release. “Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages. As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health.”