FDA: Closure of medical device sterilization facility could prompt shortages

The Food and Drug Administration is working to prevent potential medical device shortages due to the closing of a Willowbrook, Ill., facility that sterilizes medical devices, the agency announced yesterday. Sterigenics processed nearly 600 types of medical devices at the facility, including products such as sutures, clamps, knives, stents and needles. “At this time, the FDA isn’t aware of any device shortages attributable to the Willowbrook facility closure,” said FDA Commissioner Scott Gottlieb, M.D. “We’re closely monitoring the situation and will continue to provide updates.” FDA also expects a sterilizing facility operated by Viant in Grand Rapids, Mich., to close later this year. The agency is encouraging medical device manufacturers to consider alternative contract sterilizers that can process their devices. Among other actions, FDA has established an email address for reporting anticipated device shortages or distribution delays at deviceshortages@fda.hhs.gov.