November 2, 2022

FDA issues Safety Communication on tracheostomy tube shortages

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on October 31 issued a Medical Device Safety Communication on tracheostomy tube shortages.

Included in the shortages are Bivona tracheostomy tubes manufactured by ICU Medical, which are more likely to affect pediatric patients. Also on the shortage list are JOH Tube Tracheostomy and Tube Cuff and BTO Tube Tracheostomy (w/wo Connector).

The FDA is advising providers to reuse tracheostomy tubes or switch to appropriate alternatives during the shortage.

A shortage of raw materials is causing the problem. Data is not available to estimate duration of the shortage at this time, the FDA says.

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