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FDA: Device Sterilizing Facility Shutdown Could Have Impact

WASHINGTON — The closure of an Illinois facility that sterilizes medical devices could create an unusual shortage situation, the FDA warned Wednesday.

Sterigenics’ operation in Willowbrook, Illinois, closed February 15 under a state order related to emissions of ethylene oxide, a common sterilant used to disinfect devices, such as endoscopes used in gastrointestinal procedures. It’s also a known carcinogen. Air monitoring had detected potentially hazardous levels of ethylene oxide outside the facility beginning in the spring of 2018. (The company denies any problems.)

“The FDA is reaching out to medical device manufacturers to understand which manufacturers are affected by the cessation of operations at this sterilization facility. At this time, the FDA believes that more than 100 manufacturers and hundreds of devices may be affected,” the agency said in a statement.

It noted that no shortages are known to have resulted as of yet. Nevertheless, the Willowbrook closure could affect device makers in a number of ways. For example, it noted that manufacturers of devices covered by premarket approval (PMA) applications who shift their sterilization to another vendor must file notices with the FDA. That is not required for products with 510(k) clearance, but those makers must keep paperwork on file to document alternative sterilization procedures.

The FDA also urged suppliers and users to report any shortages they encounter as a result of the Willowbrook closure.