Closure of sterilization facilities could affect device supply – FDA

In a statement, the FDA reports that the availability of certain medical devices could be affected by the recent closure a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary shutdown of another Sterigenics site in Georgia and the potential closure of Becton, Dickinson’s (BDX +0.5%) large sterilization operation in Georgia.

Recently, the EPA in Illinois ordered Sterigenics to stop using ethylene oxide, the most commonly used agent to sterilize medical devices in the U.S. (more than 20B units each year), due to a higher-than-acceptable level of the gas in the air around its Willowbrook facility. The closure caused a temporary shortage of pediatric breathing tubes.

Concerns about the excessive release of ethylene oxide into the environment have prompted other states to take action. Sterigenics closed its facility in Atlanta in August while it undergoes construction aimed at reducing emissions of the compound. It does not plan to reopen the Willowbrook site.

The agency is asking device makers to keep it informed about potential supply issues. It is hosting a public advisory committee meeting on November 6 & 7 to discuss the best ways to encourage innovation in medical device sterilization.

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