Press Announcements > Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

Press Announcements > Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

FDA Efforts to Mitigate Shortage of Pediatric Breathing Tubes Due to Recent Closure of Illinois Sterilization Facility

Today, the U.S. Food and Drug Administration (FDA) issued a statement on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Sterigenics Willowbrook sterilization facility. In March 2019, the FDA was notified by health care providers, patients, and Smiths Medical that the closure of the Sterigenics Willowbrook sterilization facility caused a potential device shortage for Bivona tracheostomy tubes.  The FDA recognizes how important these essential tracheostomy tubes are to families and health care facilities and is taking steps to assure that sterilized, safe, and effective tubes are available. The FDA is working with Smiths Medical to secure availability of sterilized Bivona tracheostomy tubes for hospitals, health care providers and patients by helping Smiths Medical transition to another Sterigenics sterilization facility and expedite release of sterilized tubes that still meet the FDA’s standards for safety and effectiveness. Smiths Medical anticipates being able to resume shipping sterilized Bivona tracheostomy tubes to customers beginning the week of April 22, 2019. Parents, caregivers and health care providers can continue to clean and sterilize these tubes according to the instructions for use that are included with every tube.

Read the Statement

Questions? For more information, see the Ethylene Oxide Sterilization for Medical Devices web page. If you have questions about medical device supply issues or shortages, contactDeviceshortages@fda.hhs.gov.