Dive Brief:
- Sterigenics announced Monday it will no longer attempt to reopen its ethylene oxide sterilization facilities in Willowbrook, Illinois due to an "unstable legislative and regulatory landscape" in the state.
- The decision comes despite a recently approved consent order with Illinois that appeared to offer the company a path to resuming medical device sterilization if it received a permit from the state Environmental Protection Agency after installing new emissions capture and control systems.
- While major medical device companies such as Boston Scientific and Medtronic have already shifted EtO sterilization to other facilities after the Willowbrook facility was forced to close in February following a seal order from the Illinois EPA, it is unclear what the repercussions of the permanent closure of the plant will be. Sterigenics said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."
Dive Insight:
The decision by Sterigenics to leave Willowbrook may not bode well for the medical device supply chain with the federal EPA currently developing new regulations on commercial sterilizers and FDA recently warning medical device shortages could result from the temporary closure of a contract sterilization facility in Georgia.
Sterigenics said the decision comes after it failed to renew the lease for its Quincy Street facility in Willowbrook despite the Illinois EPA approving a permit for the company to begin installing new control measures and the recent consent order with Illinois.
"Unfortunately, inaccurate and unfounded claims regarding Sterigenics and the unstable legislative and regulatory landscape in Illinois have created an environment in which it is not prudent to maintain these critical sterilization operations in Willowbrook," the company said in a statement.
Medtronic and Boston Scientific were among companies forced to shift sterilization away from Willowbrook following its closure.
"Through diversifying our sterilization supply network, we overcame the challenges related to a supplier's sterilization facility shutdown in February, returning to full sterilization capacity during the quarter," Medtronic CEO Omar Ishrak said on the company's Aug. 20 earnings call.
EtO, a carcinogenic gas used to sterilize more than 50% of medical devices, has fallen under scrutiny by communities in close proximity to sterilization facilities. Multiple lawsuits have been filed against Sterigenics and other sterilizers alleging inadequate emission controls resulted in cancer cases.
AdvaMed and its member companies have been active in lobbying the federal government, warning Congress and the White House that stringent emission standards could hamstring the medical device supply chain and endanger patients.
But Sterigenics' decision to cease EtO operations in Willowbrook comes after a number of actions by state politicians including the passage of a state law targeting emissions from sterilization facilities.
Rep. Dan Lipinski, D-Ill., called the decision by Sterigenics to leave Willowbrook a victory for nearby residents. The congressman told MedTech Dive in an email he will continue to push for strict federal ethylene oxide standards, which he argues are needed to protect the health and safety of Americans.
"This fight has been going on for more than a year and has taken a tremendous amount of work by scores of people, but it was worth it to protect families from further exposure to this dangerous cancer-causing agent," Lipinski said.
Illinois Democrat Gov. JB Pritzker echoed Lipinski, saying state actions were critical to bringing ethylene oxide sterilization to an end in Willowbrook.
"From shutting down their operations in February to enacting the nation’s strongest law regulating ethylene oxide, we sent a clear, unified message that we will take all possible steps to protect residents’ health," Pritzker said on Twitter.
FDA did not have a comment in time for publication.
