The medical supplier's emission control system meets state approval. So now it is looking for a federal OK to re-sterilize used face masks for hospitals.
Medline Industries is pursuing U.S. Food and Drug Administration approval of a plan to resterilize hundreds of thousands of healthcare workers' face masks now that sterilization services are back online at its Waukegan, Il. facility.
Medline said in a statement Friday that it brought three shifts a day back to work at the facility, sterilizing medical devices with ethylene oxide. After a months-long shutdown of the plant because of concern over emissions of the cancer-causing chemical, the company's $10 million investment in emissions control was certified by the Illinois Environmental Protection Agency, giving it the green light to return to operations.
Medline spokesman Jesse Greenberg said in an email that the Northfield-based company now hopes to reprocess 100,000 face masks per week used by healthcare workers and ship the decontaminated masks back to hospitals. The email said the company is very close to receiving FDA emergency-use approval for this process.
"Medline has validated our decontamination process (using ethylene oxide) and successfully tested the reprocessed masks for bacterial filtration efficiency and fit," Greenberg's email said.
The Illinois EPA said in the statement that it gave clearance for Medline to resume operations following consultation between the agency and the Illinois attorney general's office.
"Illinois is leading the nation with the most stringent ethylene oxide emission standards in the country," Greenberg said in the statement. "At this critical time for the national public health, we are gratified that we can help supply sterile medical equipment to Illinois healthcare professionals working on the frontlines and to clinicians battling COVID-19 across America."
"We're seeing demand up 300% from traditional inventory levels and already Medline has shipped 15 million more face masks year to date than 2019," Greenberg's email today said.
Sterigenics shuttered its ethylene oxide facility in south suburban Willowbrook in August. The Oak Brook, Il.-based company said in a statement it would require full local, state and federal support to re-open.
"Sterigenics continues to safely meet the vital need for sterilized medical products across the country and around the world," the statement said. "Although the company maintains a lease on its sterilization facility in Willowbrook, that facility was closed given the unstable legislative and regulatory environment in Illinois. Consistent with its commitment to protecting public health, Sterigenics could revisit the decision to close were the company to receive the full support of local, state and federal officials."
This story first appeared in our sister publication, Crain's Chicago Business.