FDA Mitigating Pediatric Tracheostomy Tubes Shortage

FDA says it is helping to mitigate a temporary shortage of pediatric breathing tubes due to the recent closure of Sterigenics’s Willowbrook, IL sterilization facility. Last month, the agency was notified by health care providers, patients, and Smiths Medical that the facility’s closure caused a potential device shortage for Bivona tracheostomy tubes. An agency notice says it is working with the company to secure availability of sterilized Bivona tracheostomy tubes for hospitals, health care providers and patients by helping the 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 4/22/2019,” the agency says.