April 17, 2019

FDA issues statement on trach tube shortages

By: Judy Mathias

Editor's Note

The Food & Drug Administration on April 12 issued a statement about the agency’s efforts to mitigate the shortage of Smiths Medical’s Bivona tracheostomy tubes, especially the pediatric tubes.

The shortage is a result of the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, and there is a future planned closure of a similar facility in Michigan.

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The FDA says it is working closely with the company to quickly resolve its sterilization challenges and estimates that the tracheostomy tubes could be available again beginning April 22.


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