FDA is warning of a possible shortage of sterilized medical devices — and an accompanying threat to public health — due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide.
Agency officials believe that more than 100 medtech manufacturers and hundreds of devices may be affected by the shutdown. The Illinois Environmental Protection Agency issued an order Feb. 15 to stop the facility from sterilizing medical and other products using ethylene oxide, after the U.S. Center for Disease Control’s Agency for Toxic Substances and Disease Registry concluded that “an elevated cancer risk exists for residents and off-site workers in the Willowbrook community surrounding the Sterigenics facility,” referencing a “30-fold increase in cancer potency.”
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