The change is expected to facilitate broader adoption of vaporized hydrogen peroxide as a sterilization method and is part of a larger plan to reduce the use of ethylene oxide — the most commonly used method for devices in the U.S. — and encourage the development of alternatives.
The guidance revision is for the makers of medical devices, which for devices labeled as sterile must demonstrate their sterilization process is effective and consistent with consensus standards recognized by the FDA.
“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,” Suzanne Schwartz, MD, director of strategic partnerships and technology innovation in the FDA’s Center for Devices and Radiological Health, said in a news release. “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.”
The Environmental Protection Agency has long raised concerns about ethylene oxide emissions and long-term exposure to the gas, which is associated with high cancer risks.
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