FDA alerts providers to temporary shortage of breathing tube

The Food and Drug Administration Friday hospitals and others to a temporary shortage of a tracheostomy tube used to help adult and pediatric patients breathe in health care facilities and at home. Made by Smiths Medical, the Bivona tracheostomy tubes are sterilized with ethylene oxide before they are marketed in the U.S. FDA last month announced the potential for medical device shortages due to the closure of a large ethylene oxide sterilization facility in Willowbrook, Ill., and the future planned closure of a similar facility in Michigan. The temporary shortage is more likely to impact pediatric patients because the supply of alternative tubes for pediatric patients is limited, FDA said. 鈥淲e 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,鈥 the agency said. Health care professionals who have patients urgently in need of a new Bivona tube should contact Smiths Medical directly to inquire about current inventory, FDA said.