FDA Posts Information about Ethylene Oxide Sterilization and Medical Devices

Today, the U.S. Food and Drug Administration (FDA) issued a Commissioner’s statement on our steps to monitor the medical device supply chain and ensure safe and effective sterilization amid shutdown of ethylene oxide contract sterilization facilities.

Sterilized medical devices that have been treated to remove potentially harmful germs and other microorganisms are critical to our health care system and patient care. Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe.

The FDA is actively working with sterilization experts, medical device manufacturers, and other government agencies to advance innovative ways to sterilize medical devices with lower levels of currently used agents and employ new agents or alternatives, while maintaining device safety and effectiveness.

Read more on the FDA’s Ethylene Oxide Sterilization for Medical Devices web page.

Questions?

If you have questions about medical device supply issues or shortages, contactDeviceshortages@fda.hhs.gov