FDA posts information about ethylene oxide sterilization and medical devices

March 28, 2019

Earlier this week the Food and Drug Administration (FDA) issued a Commissioner’s statement on the agency’s steps to monitor the medical device supply chain and ensure safe and effective sterilization amid shutdown of ethylene oxide contract sterilization facilities. FDA now has a new page detailing what ethylene oxide is, how it is used and its health risks. The agency is also collaborating with sterilization experts, medical device manufacturers and other government agencies to identify other methods of sterilization.

Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. For many medical devices, sterilization with ethylene oxide may be the only method that properly sterilizes and does not damage the device during the sterilization process. Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide. Literature shows that about 50 percent of all sterile medical devices in the U.S. are sterilized with ethylene oxide. However, the gas is also toxic.

The Clean Air Act requires the EPA to regulate emissions of hazardous air pollutants from industrial facilities, and to control these emissions by developing and implementing standards and guidelines. Ethylene oxide – a hazardous air pollutant – is emitted from several types of industrial facilities that are regulated by EPA, including:

·        Commercial Sterilizers

·         Miscellaneous Organic Chemical Manufacturing

·         Hospital Ethylene Oxide Sterilizers

·         Polyether Polyols Production

·         Synthetic Organic Chemical Manufacturing Industry

The FDA plans to hold an advisory committee meeting this year to discuss how best to advance innovations in medical device sterilization. The FDA will announce the meeting, including details about how to participate, on the FDA Advisory Committee calendar web page and in a Federal Register notice prior to the scheduled date.