Sterilizer plant shutdown prompts FDA action on device shortages
- FDA said Tuesday it has been working with medtech manufacturers to prevent possible shortages of more than 600 types of devices resulting from the shutdown of Illinois contract sterilization operation Sterigenics, which the agency first flagged in February, as well as the planned closing of a second facility in Michigan, operated by Viant Medical.
- Both closures are related to elevated emissions of ethylene oxide, a gas used in about half of medical device sterilizations, found outside the facilities, which environmental regulators said raised cancer risk for people in the area.
- FDA said it isn't aware of any device shortages at this time related to the closures. Sterigenics listed 594 types of devices that were subject to an ethylene oxide sterilization process at its facility, including sutures, clamps, knives, stents and needles, while Viant listed 46 types of devices, such as catheters and surgical mesh.
The Illinois Environmental Protection Agency (IEPA) in February ordered the closing of the Sterigenics facility in Willowbrook, Illinois, due to high levels of ethylene oxide emissions the agency determined posed an elevated cancer risk for residents and workers in the area. A second ethylene oxide sterilization facility, operated by Viant Medical in Grand Rapids, Michigan, is scheduled to close later this year after the Michigan Department of Environmental Quality found air quality violations during an investigation at the location.
In the Willowbrook case, the IEPA issued a seal order on Sterigenics' ethylene oxide storage vessels to prevent any new sterilization cycles. The state said it took the action after Sterigenics refused to suspend operations voluntarily despite numerous discussions, including with the Illinois Attorney General's Office, on reducing elevated emissions levels first detected during air sampling in spring 2018. A U.S. District Court judge upheld the order, which Sterigenics sought to have reversed, arguing the high readings could not have come from its facility, according to Chicago media reports.
Viant Medical announced plans to shut its Grand Rapids sterilization facility, saying the work is not part of its core business, after sampling by the state of Michigan in November resulted in regulatory action. It said it would operate the plant in compliance with its state permit until the shutdown. No date for the closure was given.
About half of all sterilized medical devices use ethylene oxide, which is considered safe and effective, FDA said. Devices sterilized with the gas range from wound dressings to kits used in routine hospital procedures.
There's a risk of spot shortages for some sterile packaged products already in distribution, as healthcare facilities use inventories before alternative arrangements can be made to sterilize devices coming off of manufacturing lines, FDA said. The agency is working directly with manufacturers that need to transition to another sterilization site or method.
Given the environmental risks associated with ethylene oxide, FDA said, it has begun to explore the validation of methods that would use lower levels of agents like ethylene oxide, or new sterilization agents or processes altogether.
FDA identified the prevention of medical device shortages as a new regulatory priority in its fiscal 2020 budget justification report issued earlier this month. It wants authority to make companies notify the agency if a significant interruption in the supply of an essential device is expected, and to be able to allow temporary importation of devices when the risk of shortages outweighs compliance with U.S. regulatory standards.
It plans to discuss the issue at the May meeting of the Healthcare Infection Control Practices Advisory Committee held by the Centers for Disease Control and Prevention in Atlanta. FDA further plans to host its own public advisory committee meeting later this year, at a date to be announced, that will focus on encouraging new sterilization methods.
- FDA Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility
- CBSlocal.com Illinois EPA Orders Sterigenics To Halt Sterilization Operations Using Ethylene Oxide
- CBSlocal.com Sterigenics Loses Round One At Federal Hearing Against Illinois EPA