FDA Approves Vaporized Hydrogen Peroxide as Ethylene Oxide Alternative for Medical Device Sterilization

Vaporized hydrogen peroxide (VHP) is now recognized as an established method of sterilization for medical devices according to an announcement by the US Food and Drug Administration (FDA) on January 8, 2024.  

“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,” stated the announcement.  

The announcement recognizes VHP’s long history of safety and effectiveness and supports the FDA’s efforts to reduce the use of ethylene oxide (EtO) where possible. While EtO is currently the most used sterilization method for medical devices in the US, the FDA has promoted the development of alternatives to EtO since 2019.  

“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. “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.” 

VHP is not a part of the FDA’s Established Category A sterilization methods. Other methods with a history of safe and effective use on medical devices include moist heat, dry heat, EtO, and radiation. The agency hopes to strengthen the industry’s capacity to “…adopt alternative sterilization processes that pose less potential risk to the environment and communities in which they operate.”  

References

FDA facilitates broader adoption of vaporized hydrogen peroxide for medical device sterilization. News Release. FDA. Published January 08, 2024. Accessed January 17, 2024. www.fda.gov/news-events/press-announcements/fda-facilitates-broader-adoption-vaporized-hydrogen-peroxide-medical-device-sterilization