FDA Encourages Vaporized Hydrogen Peroxide as Possible EtO Alternative
The U.S. Food and Drug Administration (FDA) announced that it considers vaporized hydrogen peroxide (VHP) to be an “established method of sterilization” for medical devices.
The agency revised its 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 FDA hopes the update will bring about broader VHP adoption, part of its multi-pronged approach to reducing ethylene oxide (EtO) use.
Since 2019, the FDA has promoted development of EtO alternatives and implemented programs and initiatives to foster innovation in medical device sterilization. This included making Sterilization Master File Pilot programs to support sterilization process changes, innovation challenges to encourage strategies to reduce EtO emissions and development of new sterilization methods or technologies, and engaging with the industry.
Methods with a long history of safe and effective use on medical devices are considered Established Category A sterilization methods and include moist heat, dry heat, EtO, and radiation. With the recent agency recognition of the ISO standard 22441:2022, the FDA is adding VHP to Established Category A.
“The FDA’s commitment is to protect public health, a critical mission in today’s complex medical device ecosystem,” said Suzanne Schwartz, MD, M.B.A., 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.”