In light of recent shutdowns of two contract sterilization facilities over environmental concerns, FDA said it is exploring ways to ensure sterilization processes are safe and effective and evolving with the current science.MD+DI/Amanda Pedersen
Last month FDA warned of potential medical device shortages amid a shutdown of facilities that use a gas called ethylene oxide (EtO) to sterilize medical devices. The situation is already impacting children who use Smiths Medical's Bivona tracheostomy tubes.
The devices were previously sent to Sterigenics' Willowbrook, IL facility for EtO sterilization, but the Illinois EPA recently issued a seal order at that facility after finding dangerously high levels of the gas in the air around the facility. Viant Medical, another contract sterilizer, also plans to close its EtO sterilization facility in Grand Rapids, MI after receiving attention from the Michigan Department of Environmental Quality for air quality issues.
"Smiths Medical is experiencing a severe supply disruption on the Bivona tracheostomy tubes due to the [EPA] shutdown of the Sterigenics sterilization site in Willowbrook, IL," Central Ohio Specialty Care (COHSC), a home medical equipment provider, said in a Facebook post. "This shutdown will result in a nationwide shortage of all standard/stock Bivona tracheostomy tubes, and all sterile, custom Bivona tracheostomy tubes."
COHSC said custom, non-sterile tubes should not be impacted.
According to Smiths Medical, Bivona tubes can be cleaned and sanitized at home for up to 10 re-insertions for adult sizes or up to five times for neonatal and pediatric sizes.
"Do not dispose of any Bivona trachs unless they have been sterilized the maximum number of times, or appear damaged in any way," COHSC said.
Smiths Medical told customers in a letter dated April 1 that it has completed two sterilization cycles with Bivona tracheostomy tubes at a new sterilization site but it must have finalized testing results for the two cycles before the devices can be distributed.
"We are on track to have the preliminary results for these two cycles available within the next two weeks. These results are critical to finalizing the timeline and understanding when we will be able to get sterile Bivona tracheostomy tubes to you and your patients," Joan Cummings, marketing director at Smiths Medical, said in the letter.
Roseville, MN-based Pediatric Home Service, an independent home health agency, recently published information for customers on how to safely reuse the tubes that they have on hand.
"We are being told to use our current trachs for longer than is considered acceptable by the manufacturer's standards," Megan Molidor, whose daughter Jocelyn uses Bivona tracheostomy tubes, told MD+DI.
As of March 25, FDA said it was not aware of any device shortages attributable to the Willowbrook facility closure.
"This is a life saving artificial airway device and something to be taken seriously," Molidor said. "I find a group of high-risk children being impacted severely as an unacceptable byproduct of this closure. This needs to be addressed."