UPDATE: March 30, 2020: Medline said Friday it resumed ethylene oxide sterilization operations at a facility located between Chicago and Milwaukee, after spending $10 million to improve emissions capture in accordance with updated Illinois environmental regulations.
The news came roughly two months after local health regulators predicted the facility may restart operations following adequate testing of the new controls.
In a statement March 27, Medline touted the role the facility will immediately play in helping supply sterile personal protective equipment and devices such as oxygenators involved in the response to COVID-19.
UPDATE: Feb. 3, 2020: Medline did not meet local authorities' expectations to reopen its Waukegan sterilization plant during the week of Jan. 27, spokesperson Jesse Greenberg confirmed Friday.
"Medline is still on a temporary pause to our sterilization operations in Waukegan as we finish balancing and testing our newly installed $10 million investment in best available emissions abatement technology," Greenberg said via email. "We’re communicating regularly with all local, state and federal regulatory agencies on the status of our project."
- Medline Industries has not operated its Waukegan, Illinois sterilization since Dec. 13, the Lake County Health Department wrote in an update Tuesday.
- The temporary closure came as a result of Medline not yet meeting new state standards for emissions of ethylene oxide, a carcinogenic gas used to sterilize at least half of U.S. medical devices.
- The Lake County Health Department wrote in an ethylene oxide status update Friday that Medline began installing additional pollution controls in late November, but did not finish installation by December. It now expects the facility to resume operations the week of Jan. 27 amid testing of new emissions controls.
Illinois has been one of the biggest flashpoint states for ethylene oxide regulations in the past year. Governor JB Pritzker signed two pieces of legislation last June that "impose the strictest limits in the nation" on EtO emissions from sterilization facilities and companies, according to the Illinois EPA. Those laws requiring emission controls, modeling of emissions' dispersion and ambient air monitoring took full force at the end of 2019.
"From the time it received its building permit in October, Medline has been working around the clock to complete nearly $10 million in upgrades at our Waukegan plant," Medline spokesperson Jesse Greenberg said in a statement shared with MedTech Dive Tuesday.
The future of contract sterilizers' across the country lies partly with the U.S. Environmental Protection Agency, which issued an advanced notice of proposed rulemaking in early December in regard to a future rule on EtO commercial sterilization and fumigation operations. EPA is targeting February for a proposed rule; AdvaMed requested a 30-day comment docket extension for the advanced notice of proposed rulemaking, citing the large number of medical device commercial sterilization operations to be affected by the rule.
The trade association lobbied federal EPA administrator Andrew Wheeler last year, hoping to ensure regulations that don't constrict U.S. medical device supply. AdvaMed Chairman Kevin Lobo has called potential threats to ethylene oxide sterilization one of the biggest challenges currently facing the device industry. And a top FDA official has warned that as few as two more plant closures would be a catastrophic event.
As for Medline's plant in question, the company assured that it would only be a temporary stoppage.
"While Medline completes the final stages of balancing and testing this equipment, we are temporarily pausing sterilization operations," Medline said in its statement. "We anticipate resuming full operations within a few weeks ... When finished, Medline will abate more than 99.9% of all EtO used at our facility."
An FDA spokesperson said Tuesday the agency is "currently in discussions with Medline to determine the potential impact on device availability."
The Lake County update Friday also disclosed that Vantage, another Illinois sterilizer, installed pollution controls last April and met compliance with state laws before December. Both Medline and Vantage have been on the receiving end of lawsuits claiming ethylene oxide emissions from their facilities subjected nearby residents to elevated risk of developing cancer.
In a Jan. 7 statement, Greenberg said Medline's most recent air samplings in Waukegan showed ethylene oxide incidence "well below the national average." A Centers for Disease Control and Prevention-funded study presented at a public meeting Jan. 12 indicated that non-smoking residents living within half a mile of the Medline facility had higher average levels of ethylene oxide hemoglobin adducts, an indicator of exposure to the gas, compared to other non-smoking Lake County residents. The University of Illinois at Chicago researchers did not see a similar trend in residents living close to Vantage's facility.
"The researcher’s report indicated that the 'results should be interpreted as pilot data' and that a 'larger investigation could be performed to confirm these results'," the Lake County Health Department summarized in its recent update.
This story has been updated with the latest on the plant's potential reopening.