FDA Monitoring Potential Device Shortage After Atlanta Sterigenics Facility Temporarily Closes

By MedTech Intelligence Staff

Will more medical devices be impacted?

Last Friday FDA posted another update to its website about a temporary closure of a Sterigenics sterilization facility in Atlanta. The facility was closed on August 26 and is undergoing construction to reduce ethylene oxide emissions, according to the agency. FDA is communicating with Sterigenics and device companies that could be affected by the closure.

The issue surrounding ethylene oxide emissions by sterilization facilities came to a head in February when Sterigenics was ordered to shut down a facility in Willowbrook, Illinois. Not soon after, it was announced that another contract EtO sterilizer, Viant Medical, would also shut down its facility after receiving violation notices from the Michigan Department of Environmental Quality.

In July, FDA announced two innovation challenges to find new methods of sterilization that do not use ethylene oxide (or at least strategies to reduce emissions to find new methods of sterilization that do not use ethylene oxide. The deadline for submissions is October 15.

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