- FDA Friday alerted healthcare providers and caregivers to a temporary shortage of a tracheostomy tube made by Smiths Medical resulting from the recent closure of a large ethylene oxide (EO) sterilization plant in Willowbrook, Illinois.
- Smiths Medical's Bivona tracheostomy tubes are indicated for use in both adult and pediatric patients to help with breathing after a procedure. The temporary shortage is more likely to affect pediatric patients because an alternative supply of tubes for that group is limited, FDA said.
- The agency said it is helping the company move its sterilization processes to another facility to limit the impact of the shortage on patients, and anticipates the devices will be available again beginning the week of April 22.
The alert is FDA's first public confirmation of a device shortage tied to the shutdown of Illinois contract sterilization company Sterigenics. The agency identified the potential for shortages in February when the Illinois Environmental Protection Agency ordered the Sterigenics plant closed after determining high levels of ethylene oxide emissions posed an elevated cancer risk for residents and workers in the area. In an update last month, FDA said the facility's closing could affect 594 types of devices that were sterilized at the plant, ranging from sutures and clamps to knives, stents and needles.
Further complicating matters, a second ethylene oxide sterilization plant operated by Viant Medical in Grand Rapids, Michigan is set to close, potentially affecting 46 different devices, including catheters and surgical mesh. State environmental regulators in Michigan also found air quality violations at the facility.
FDA said it is not aware of any other device shortages due to the plant closures.
The Bivona tracheostomy tubes are sterilized with ethylene oxide before they are sold in the United States. Hospitals can clean and sterilize them for reuse on the same patient.
Although there are other FDA-cleared silicone tracheostomy tubes for pediatric patients, there may not be enough devices available to cover the shortage, the agency said. It is advising healthcare providers with patients urgently in need of a new Bivona tube to contact Smiths Medical directly and ask about current inventory.
The closure of the Willowbrook facility does not impact tubes already in use by patients. FDA said Smiths Medical is communicating with patients and caregivers about how to reuse and clean tubes in accordance with instructions.
The company is continuing to manufacture tracheostomy tubes and has begun to use an alternative facility to sterilize the devices. It estimates about 28,000 new Bivona tracheostomy tubes are awaiting sterilization.
Adult patients having trouble obtaining Bivona tubes should ask their doctors about using other FDA-cleared tracheostomy tubes, the agency said.
The Chicago Tribune reported last month that air tests conducted after the Sterigenics facility was shut down revealed a sharp drop in ethylene oxide levels at 10 monitoring sites. Sterigenics maintains there are other sources of EO in Willowbrook besides its facility.
The Illinois Department of Public Health released results March 29 of a cancer assessment for the area around the Sterigenics facility that showed elevated incidence of some cancers, including Hodgkin's lymphoma and pediatric lymphoma.