FDA Alert on Tracheostomy Tube Shortages

FDA is alerting patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. “A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited,” an agency notice says. “FDA is working closely with manufacturers and other stakeholders to help quickly resolve supply challenges and support availability of these critical devices for patients who need them.”

During the product shortage period, FDA recommends that users follow the manufacturer’s instructions for cleaning, sanitizing, and reusing tracheostomy tubes for the maximum number of times permitted. “For example, Bivona tracheostomy tubes may be cleaned, sanitized, and reused as described in A Handbook for the Home Care of Your Child with a Tracheostomy for single-patient use, as stated in the indications for use, up to five times for pediatric sizes and 10 times for adult sizes,” it says.