Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage – FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alertpatients, caregivers, and health care 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. The FDA is working closely with manufacturers and other stakeholders to quickly help resolve supply challenges and support availability of these critical devices for patients who need them. People who use these tubes, including caregivers and health care providers, should consider the FDA’s recommendations listed in the safety communication.

This safety communication provides:

• Recommendations for people who use tracheostomy tubes and their caregivers.
• Recommendations for health care providers.
• Background on the issue and the FDA’s actions to address the shortage.
• Instructions for reporting problems and supply chain issues to the FDA.

In addition, the FDA has added tracheostomy tubes (product code JOH – Tube Tracheostomy And Tube Cuff and product code BTO – Tube, Tracheostomy (w/wo connector)) to the medical device shortage list.

Questions?

See Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page.

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).