manufactured by Smiths Medical caused by the closure of a large ethylene oxide sterilization facilities in Willowbrook, Ill., and the future planned closure of a similar facility.
The shortage may affect pediatric use because, although tubes are used for both adults and children, there are fewer alternative products on the market for pediatric patients. Parents and caregivers of children who use theare encouraged to check with Smiths Medical about available inventory and with their health care providers about alternative products.
Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in a press release, “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.”
For patients currently using the Bivona tubes, Dr. Shuren noted, “The closure of the Willowbrook facility does not impact tubes already in use by patients at home or in health care settings. The company is communicating with patients about the tubes and how patients and caregivers can mitigate any potential impact, including reusing and cleaning tubes in accordance with the manufacturer’s instructions for use.”
Read the entire announcement at the FDA.