FDA warns of more device shortages linked to sterilization plant closure

Another Sterigenics sterilization plant is temporarily closed in an effort to reduce its gas emissions, which could impact medical device supply chains, the FDA warned Sept. 13.

Medical equipment sterilization firm Sterigenics is facing dozens of lawsuits claiming its ethylene oxide emissions caused cancer among residents living near their plants. Ethylene oxide is a carcinogenic gas used to sterilize the majority of medical devices.

An Atlanta-based Sterigenics plant closed earlier this month following a consent order with the Georgia Environmental Protection Division, according to MedTech Dive. While the plant is closed, Sterigenics is working to implement technology upgrades with the goal of reducing ethylene oxide emissions.

Sterigenics said the construction should be completed by the first week of October.

In its warning, the FDA told medical devicemakers to contact the agency if they are impacted by the plant's closure. The temporary closure of another Sterigenics plant in Illinois earlier this year was linked to major medical devicemakers like Medtronic and Boston Scientific losing millions in revenue.

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