Statement from Acting FDA Commissioner Ned Sharpless, M.D., on concerns with medical device availability due to certain sterilization facility closures

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on concerns with medical device availability due to certain sterilization facility closures

As the agency responsible for ensuring the safety and effectiveness of all medical devices, the U.S. Food and Drug Administration has been closely monitoring the supply chain effects of closures and potential closures of certain large-scale sterilization facilities that use a gas called ethylene oxide to sterilize medical devices prior to their use. The recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure of a large Becton Dickinson sterilization facility in Georgia could affect the availability of some sterile medical devices used by health care delivery organizations and patients. We have been working diligently with impacted device manufacturers and health care delivery organizations to ensure that they are aware of these developments and preparing to minimize adverse effects on patients whose care could be negatively affected if medical devices sterilized at these large facilities were not accessible. Medical devices that are sterilized to remove potentially harmful germs and other microorganisms prior to use are ...

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