FDA Alerts Providers of Shortage of Tracheostomy Tubes

The FDA is alerting patients, caregivers, and healthcare providers that there is 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. While FDA and the HHS Administration for Strategic Preparedness and Response (ASPR) work with medical device manufacturers and suppliers to obtain raw materials to expedite the supplies, patients, caregivers and healthcare personnel are urged to carefully follow FDA and manufacturer instructions for cleaning, sanitizing and reusing the tracheostomy tubes while supplies are limited. Read the FDA safety alert.