FDA Warns of Temporary Shortage Smiths Medical Tracheostomy Tube

PUBLISHED: Apr 16, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is alerting health care professionals, parents and caregivers that there is a temporary shortage of a type of a tracheostomy tube manufactured by Smiths Medical. Smiths Medical’s Bivona tracheostomy tubes are used in health care facilities, such as hospitals, or at home for both adult and pediatric patients. Prior to initial use, Bivona tracheostomy tubes are sterilized with ethylene oxide before they are marketed in the U.S. After initial use, patients may reuse the tubes by reprocessing them as described in Bivona’s Instructions for Use. Hospitals also may clean the tubes and sterilize them so they can be reused on the same patient.

Last month the FDA alerted the public of the potential for medical device shortages to arise from the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, and the future planned closure of a similar facility in Michigan.

Although the Bivona tubes are indicated for use in both adult and pediatric patients, the temporary shortage is more likely to impact pediatric patients because supply of alternative tubes with similar functionality is limited. The Bivona tube is made from a flexible silicone material which makes them easier to insert in the stoma of pediatric patients. While there are other FDA-cleared silicone tracheostomy tubes for pediatric patients, there may not be enough available to adequately cover the shortage. The FDA recognizes the challenges this shortage imposes for these pediatric patients who need access to new tubes now and are working to limit the impact to patients as much as possible by helping the company quickly move their sterilization to another facility.

During the temporary shortage, health care professionals who have patients urgently in need of a new Bivona tube should contact Smiths Medical directly to inquire about current inventory. Parents and caregivers who need new Bivona tubes (e.g., due to damage or leaking of current tubes) should work with their health care professionals to find an appropriate alternative until the Bivona tracheostomy tube is back on the market. Adult patients experiencing problems obtaining Bivona tubes should talk with their health care professional about using other FDA-cleared tracheostomy tubes.

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