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Regulatory Focus™ > News Articles > 2019 > 4 > Sterilization Facility Closure Leads to First Device Shortage

Sterilization Facility Closure Leads to First Device Shortage

Posted 15 April 2019 | By Zachary Brennan 

Sterilization Facility Closure Leads to First Device Shortage

With the closure of a medical device sterilization facility in Illinois, the US Food and Drug Administration (FDA) warned of device shortages, and last Friday announced a type of a tracheostomy tube manufactured by Smiths Medical is the first to be in shortage.

Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement: “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible, which we anticipate will be made available again beginning the week of April 22.”

Prior to initial use, Smiths Medical’s Bivona tracheostomy tubes are sterilized with ethylene oxide before they are marketed in the US. The sterilization previously occurred at Sterigenics’ facility in Willowbrook, IL, but that site was recently closed by the Illinois Environmental Protection Agency after questions were raised about air quality around the facility.

FDA said Smiths Medical has already started to use an alternative sterilization facility and estimates that approximately 28,000 new Bivona tracheostomy tubes are currently awaiting sterilization.

“While there are other FDA-cleared silicone tracheostomy tubes for pediatric patients, there may not be enough available to adequately cover the shortage. We recognize the challenges this shortage imposes for these pediatric patients who need access to new tubes now, and are working to limit the impact to patients as much as possible by helping the company quickly move their sterilization to another facility,” Shuren said.

Smiths Medical declined to comment on the shortage or plans to ameliorate it.

FDA encourages companies to submit any shortages to deviceshortages@fda.hhs.gov.

Ethylene Oxide Sterilization for Medical Devices

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