EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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Another medtech sterilization plant will close in 2019

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 an undated letter, “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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