03.28.19

FDA Prepares for Possible Device Shortages After Gas Leaks Lead to Closure of Sterilization Plant

Source: FierceBiotech

The FDA is working to prevent potential shortages of medical devices after the closure of an Illinois sterilization plant, which was due to a state environmental protection order, according to a report in FierceBiotech.

In mid-February, the Illinois Environmental Protection Agency halted operations at the large Willowbrook facility, run by the contract sterilizer Sterigenics, after officials found unacceptably high levels of ethylene oxide gas in the air surrounding the premises.

Ethylene oxide is commonly used to sterilize many medical devices—about half of all of them, in fact, ranging from wound dressings to stents to surgery kits used in routine hospital procedures, according to the FDA—and it’s especially useful in sterilizing components made of different materials, or that can’t be cleaned by steam.

Read the full article.

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