A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements.
The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. The FDA said it isn’t aware of any device shortages attributable to the Willowbrook facility closure but that existing supplies could be diminished or depleted, leading to spot shortages.
Later this year, Viant will close a plant that uses ethylene oxide to sterilize medical devices in Grand Rapids, Mich., because, as it told nearby residents in a letter dated March 4, “that work is not part of our core business.” The Viant plant sterilizes 46 types of devices, including catheters and surgical mesh, according to the FDA. Viant had self-reported an ethylene oxide leak to the Michigan Department of Environmental Quality (MDEQ) in 2017. The department issued a violation to Viant then and another following an MDEQ inspection in November 2018.
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