Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to advance innovation in medical device sterilization with ethylene oxide

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to advance innovation in medical device sterilization with ethylene oxide

At the U.S. Food and Drug Administration we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use. Ethylene oxide is used in the manufacturing processes for a variety of both medical and non-medical products. While potential impacts to the availability of sterile medical devices is a concern given their criticality to our health care system, we also recognize the value in reducing over-reliance on ethylene oxide in commercial operations, including for ...

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