FDA Warns Of Pediatric Breathing Tube Shortage After Manufacturing Facility Shuts Down

The recent closure of a sterilization facility in Illinois has created a national shortage of pediatric tracheostomy breathing tubes, federal regulators warn.

The FDA announced a temporary shortage of Smiths Medical’s Bivona tracheostomy tubes on April 12, which comes after the state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, due to emissions of ethylene oxide, a highly carcinogenic chemical compound used to sterilize the tubes.

The shortage primarily affects pediatric patients, although the medical devices are used on both adult and children. As a result, some patients could face a delay or disruption of certain care. However, Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, said the agency is taking steps to prevent the shortage from placing patients in danger.

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“I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible, which we anticipate will be made available again beginning the week of April 22,” Shuren said.

Last month, the FDA warned potential pediatric breathing tube shortages may occur after the Illinois plant was closed and a similar facility in Michigan was also scheduled for closure. Both plants were experiencing ethylene oxide leaks.

The agency indicated it was working to secure alternative locations and methods for sterilization for the devices processed at the facility; however, the steps failed to stop the shortage of breathing tubes.

The Smiths Medical’s Bivona breathing tubes are used in health care facilities or at home to help adult and pediatric patients breathe. The tube is implanted using a surgical procedure that creates a small opening through the skin and tissue of the neck into the trachea, or wind pipe.

The tube is then placed through the opening into the trachea to allow a patient to breathe through the tube instead of through their mouth or nose. Before the tube is inserted it is sterilized at a facility with ethylene oxide.

There are other brands of tracheostomy tubes for pediatric patients, but there may not be enough available to cover the shortage.

The FDA is working to help Smiths Medical to move their sterilization to another facility quickly and expedite the release sterilized tubes. The company already started using an interim alternative facility to sterilize the tubes; however nearly 28,000 new Bivona tubes are awaiting sterilization.

The FDA recommends patients and parents work with their doctors to find alternative devices until the Bivona breathing tube is back on the market. Doctors who have patients in urgent need of a Bivona breathing tube should contact Smiths Medical directly to find out about current inventory.


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