April 17, 2019

FDA issues statement on trach tube shortages

By: Judy Mathias
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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.

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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