The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.
The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.
“I want to assure you that the FDA is working closely with (Smiths Medical) to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible,” Schuren said in the statement.
Although the Bivona tubes are indicated for use in both adult and pediatric patients, the temporary shortage is more likely to affect children because the supply of other manufacturers’ tubes that work for children is limited. The Bivona tube is made from a flexible silicone material that makes them easier to insert into an opening in the trachea of a pediatric patient, the FDA said.
Bivona tracheostomy tubes are sterilized with EO before they are marketed in the U.S. After initial use, patients at home 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 may be reused on the same patient.
Smiths (Plymouth, Minn.) is continuing to manufacture tracheostomy tubes on its normal schedule, and has approximately 28,000 new Bivona tracheostomy tubes awaiting sterilization, according to the statement. The company has already started to use a different facility to sterilize its devices, the FDA said. Smiths Medical declined to comment.
“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. “We recognize 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.”
Shuren advised healthcare professionals whose patients urgently need a new Bivona tube to contact Smiths Medical directly. Parents and caregivers who need new Bivona tubes should work with the child’s doctor or nurse to find an appropriate temporary alternative. Adult patients experiencing problems obtaining Bivona tubes should talk with their health care professional about using other FDA-cleared tracheostomy tubes, including those made from different materials.
Shuren also said Smiths Medical is communicating with patients about the tubes and ways that patients and caregivers can minimize the shortage’s impact, including re-using and cleaning tubes.
The Sterigenics Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles, according to the FDA. A Viant plant that sterilizes 46 types of devices in Grand Rapids, Mich. will close later this year, the company told area residents last month.
The FDA is not aware of any other shortages due to these closures, and continues to monitor the situation closely, Shuren said. The agency is continuing to update its ethylene oxide in medical device sterilization web page and is working on identifying new methods for medical device sterilization. It will make those findings public in the coming weeks, according to the statement.
“We recognize the very real consequences that medical device shortages have on patients, and we’ll continue to work directly with manufacturers, contract sterilizers, government agencies and other public health stakeholders to do all we can to avert new device shortages,” Shuren said.