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Medical Devices / Commercial Operations

CDER Announces Shortage of Tracheostomy Tubes Caused by Sterilizer Shutdown

April 17, 2019
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A temporary shortage of tracheostomy tubes caused by the closure of a sterilization facility should be resolved “within the next few weeks,” CDER director Jeff Shuren said.

Shuren said CDER has identified Smiths Medical’s Bivona tracheostomy tubes, devices used in healthcare facilities and at home to assist pediatric patients with their breathing, as being in temporary shortage. The shortage follows the closure of a Sterigenics sterilization facility in Willowbrook, Illinois last month.

Smiths Medical is using an alternative facility for sterilization and said it estimated approximately 28,000 new tubes are currently waiting to be sterilized.

“We are working closely with Smiths Medical to expedite release of sterilized tubes that still meet the FDA’s standards for safety and effectiveness and expect new tubes to be available within the next few weeks,” Shuren said.

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