Concerns with Medical Device Availability Due to Certain Sterilization Facility Closures

The FDA is closely monitoring the supply chain effects of closures and potential closures of certain facilities that use ethylene oxide to sterilize medical devices prior to their use. The Agency is concerned about the future availability of sterile medical devices and the potential for medical device shortages that might impact patient care. Additionally, the FDA is working with device manufacturers and health care delivery organizations to ensure they are aware of the issues and preparing to reduce the patient impact if medical devices sterilized at these sterilization facilities become unavailable.

Read More Questions? If you have questions or need to report a medical device shortage or supply issue, email Deviceshortages@fda.hhs.gov.