Medline hasn't been sterilizing medical equipment at its Waukegan, Ill., facility since mid-December because it didn't finish construction needed to meet new state standards for ethylene oxide emission in time, according to the Lake County Health Department.
Illinois Gov. J.B. Pritzker signed two pieces of legislation last June that put strict limits on ethylene oxide from sterilization facilities like Medline. The legislation went into effect at the end of 2019.
Ethylene oxide is a chemical used to sterilize more than half of the country's medical devices, but has been shown to increase the risk of cancer in humans if they're exposed to it for long periods.
Medline began installing equipment in November to help it decrease the amount of ethylene oxide it released into the air while sterilizing, but didn't finish the construction in time to meet the state's new standards, MedTech Dive reported.
A Medline spokesperson told Becker's Hospital Review that the halt in sterilization operations was a "voluntary pause in our operations that started in mid-December so that we could finish construction and meet all the requirements of the Matt Haller Act that went into effect at the end of 2019."
The facility should resume sterilization during the week of Jan. 27, according to the Lake County Health Department.
"When finished, Medline will abate more than 99.9% of all EtO used at our facility," the spokesperson continued.
An FDA spokesperson told MedTech Dive that the agency is working with Medline to determine if there has been any impact on the availability of medical devices.
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