FDA panel searching for alternative medical device sterilization techniques

The FDA is holding a two-day meeting with the General Hospital and Personal Use Devices Panel to develop strategies to reduce reliance on ethylene oxide to sterilize medical devices.

The FDA warned of critical medical device shortages Oct. 25 after sterilization plants in Illinois and Georgia were closed due to concerns that ethylene oxide, which is the most commonly used chemical to sterilize medical devices, causes cancer.

Three dozen people sued Sterigenics, an Illinois-based medical device sterilization plant, alleging its ethylene oxide emissions adversely affected their health. The Illinois Environmental Protection Agency determined the plant released an unhealthy amount of ethylene oxide.

In Georgia, Gov. Brian Kemp is trying to shut down a Becton Dickinson sterilization plant due to concerns that its ethylene oxide emissions cause cancer.

There are currently no alternatives to ethylene oxide sterilization, which the FDA has said is a "well-established, scientifically-proven method of preventing harmful microorganisms from reproducing and causing infections."

The goal of the meeting, set for Nov. 6 -7 in Gaithersburg, Md., is to get input on how to reduce ethylene oxide emissions without compromising the assurance of sterility of medical devices.

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