CHA News Article

FDA Issues Statement on Sterilization Facility Closures and Potential Medical Device Shortages
For CNOs, quality & patient safety staff, infection preventionists

The Food and Drug Administration (FDA) has issued a statement alerting the public to potential medical device shortages due to the recent closures of certain facilities that sterilize devices using ethylene oxide.

Specifically, concerns about the release of ethylene oxide into the environment at potentially unsafe levels have resulted in certain state actions against sterilization facilities. Those actions are currently impacting manufacturers’ ability to use the ethylene oxide process to sterilize their medical devices. The FDA urges health care providers and medical device makers to assess their supplies of affected devices and report anticipated shortages or distribution delays by email to deviceshortages@fda.hhs.gov.

The FDA is communicating directly with manufacturers to monitor the supply of devices sterilized in facilities that have closed or that may close, paying special attention to life-saving, life-sustaining, and other critical devices.

 The FDA also previously announced two new innovation challenges to encourage ideas from stakeholders, academics, industry and others about solutions for improving sterilization processes, including a call to identify new or alternative sterilization methods, and to develop new strategies to reduce ethylene oxide emissions. In addition, the FDA will hold a public advisory committee meeting on November 6 and 7 dedicated to discussions on how best to encourage innovation in medical device sterilization.

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