Wednesday, 15 January 2020

Updates on Ethylene Oxide Sterilization of Medical Devices: Recent FDA Actions

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

FDA innovation Challenges

On June 15, 2019, the FDA announced two Innovation Challenges to identify sterilization alternatives and reduce ethylene oxide 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.

Ethylene Oxide Sterilization Master File Pilot Program

On Novembr 25, 2019, the FDA announced 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 postapproval report instead of submitting a traditional PMA supplement.

General Hospital and Personal Use Devices Panel Advisory Committee Meeting

On November 6 and 7, 2019, the FDA held an advisory committee meeting to discuss ethylene oxide 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.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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