FDA updates on EtO sterilization of medical devices

Nov. 25, 2019

Today, the U.S. Food and Drug Administration (FDA) is providing information on recent actions responding to ongoing concerns about ethylene oxide (EtO) in commercial operations and encouraging innovative approaches to medical device sterilization.

On June 15, 2019, the FDA announced two Innovation Challenges to identify sterilization alternatives and reduce EtO emissions. The FDA received 46 applications from companies large and small. After careful review using an established set of criteria, 12 challenge applicants have been selected to participate.

The FDA announced today its Ethylene Oxide Sterilization Master File Pilot Program (EtO Pilot Program). This voluntary program is intended to streamline the submission process, so that sterilization providers that sterilize single-use medical devices using fixed chamber sterilization processes may submit a Master File to the FDA when making certain changes between sterilization sites, or when making certain changes to sterilization processes that utilize reduced ethylene oxide concentrations, and PMA holders can reference such a Master File in a post-approval report instead of submitting a traditional PMA supplement.

Read the Federal Register notice

On Nov. 6 and 7, 2019, the FDA held an advisory committee meeting to discuss EtO sterilization of medical devices and its role in maintaining public health. Based on panel discussions, the FDA is encouraging device manufacturers to move to electronic labeling and instructions for use in the near term and is committed to working with industry to make this change.

Read the meeting summary

FDA has the notice.

Photo 77197506 © Korn Vitthayanukarun | Dreamstime.com
Image courtesy of Kat Velez, LeeSar Regional Service Center, Fort Myers, FL, HPN’s 2017 SPD of the Year
261278015 © Александр Лебедько | Dreamstime.com