The closing of an ethylene oxide sterilization plant in Illinois has led to a temporary shortage of Bivona tracheostomy tubes manufactured by Smiths Medical, the US Food and Drug Administration (FDA) said Friday.
Although Bivona tracheostomy tubes are used in both adults and children, the shortage is more likely to affect children because availability of alternative tubes with similar functionality is limited. The Bivona tube is made from a flexible silicone material that makes it easier to insert into the stoma of pediatric patients, the FDA says.
Bivona tracheostomy tubes are sterilized with ethylene oxide before initial use and marketing.
On February 15, the Illinois Environmental Protection Agency ordered the shutdown of the Sterigenics plant in Willowbrook, which sterilized the tubes, after outdoor ambient air sampling detected high ethylene oxide emissions, which “present an imminent and substantial endangerment to residents and off-site workers in the Willowbrook community,” according to a statement on Illinois.gov. Ethylene oxide is known to cause cancer.
The FDA is working with Smiths Medical to resolve their “sterilization challenges” and is also looking for alternative locations and methods of sterilization of devices that were previously processed at the Willowbrook facility, Jeff Shuren, MD, director of the Center for Devices and Radiological Health, said in a statement.
Smiths Medical is continuing to manufacture the tracheostomy tubes on their normal schedule and currently has about 28,000 new Bivona tracheostomy tubes awaiting sterilization.
“We are working closely with Smiths Medical to expedite release of sterilized tubes that still meet the FDA’s standards for safety and effectiveness and expect new tubes to be available within the next few weeks,” Shuren said.
The FDA said it anticipates the Bivona tubes will be available again beginning the week of April 22.
During the temporary shortage, healthcare professionals whose patients urgently need a new Bivona tube should contact Smiths Medical directly to ask about current inventory, the FDA advises.
In addition to Bivona tracheostomy tubes, the Sterigenics Willowbrook plant sterilizes 594 types of devices including sutures, clamps, knives, stents, and needles, which could also be affected by the closure.
In March, the FDA learned that the Viant Medical sterilization plant in Grand Rapids, Michigan, will close later this year, following detection of higher-than-expected ethylene oxide emissions. Viant sterilizes 46 types of devices including catheters and surgical mesh, which in the future could be affected by the plant’s closing.
The FDA is monitoring the situation, including submissions to the agency’s device shortages mailbox, and will continue to provide updates on the Ethylene Oxide Sterilization for Medical Devices webpage.