Could Illinois' ban on a medical instrument cleaner spark a public health crisis?

The chemical process used to sterilize most medical products was evaluated during committee hearings in Springfield this week, due to cancer risks associated with ethylene oxide emissions. Medical product manufacturers say that, with no suitable alternative, banning the process could cause a public health crisis.

Without ethylene oxide, medical supplies that can't be sterilized using other methods "would very quickly become unavailable," said Lara Simmons, group president of quality assurance and regulatory affairs for Medline Industries, a manufacturer and distributor of medical products in Northfield. "We know from experience that when you have a serious disruption in the medical supply chain like that, it impacts patient safety and health. If you don't have a pack available to do surgery—open heart, hip replacement, maybe an emergency cath lab procedure—that patient isn't going to get treatment."

The ethylene oxide issue came to light earlier this year, after the U.S. Environmental Protection Agency investigated the relationship between emissions from Willowbrook-based sterilization services provider Sterigenics and high cancer risks in the surrounding area.

The EPA classified the compound as a human carcinogen in December 2016, according to the agency's website, which notes that studies of workers show exposure to ethylene oxide is associated with an increased risk of cancers of the white blood cells, in addition to an elevated risk of breast cancer in women.

The Illinois House Environment Committee hearing yesterday addressed HB 5985—sponsored by Rep. Carol Sente of Vernon Hills and Rep.-elect Laura Fine of Glenview, both Democrats—which aims to ban the use of ethylene oxide by Jan. 1, 2021.

The Illinois Senate Environment & Conservation Committee hearing today addressed SB 3630—sponsored by Republican Sens. John Curran of Woodridge, Chris Nybo of Lombard and William Sam McCann of Jacksonville—which aims to evaluate air pollution operating permits for facilities emitting ethylene oxide; and SB 3640—sponsored by Curran and Sen. Melinda Bush of Grayslake, a Democrat—which calls for a ban by Jan. 1, 2022.

Late last month, Attorney General Lisa Madigan, a Democrat, and DuPage County State's Attorney Robert Berlin, a Republican, filed a lawsuit against Sterigenics, alleging ethylene oxide emissions from the facility have "threaten(ed) to injure the health of people living and working near the source (and) have caused fear in the community due to the threat to public health." The lawsuit seeks to set emission limits on ethylene oxide and, if warranted, cease operations.

An epidemiologist who testified during today's hearing on behalf of Medline said the emissions are low enough that they're likely unrelated to cancer risks. Meanwhile, Medline's Simmons says "the ability to sterilize large quantities of products at one time in an efficient manner (using ethylene oxide) is critical to keeping hospitals supplied."

"Swedish Covenant Hospital discontinued the use of ethylene oxide sterilization on-site in 2014 in favor of a method that uses hydrogen peroxide, a safer chemical for the (sterile processing department) staff and the environment," Roseann Oesterblad, the hospital's director of sterile processing, said in a statement provided to Crain's.

"However, there are many disposable items that our hospital purchases through a third-party vendor that are sterilized using ethylene oxide," such as bandages and catheters, she adds. "There would be a shortage of disposable supplies if the use of (ethylene oxide) sterilization was immediately shut down."

In addition to hydrogen peroxide, steam and gamma radiation are among alternative sterilization methods that Simmons says are not compatible with certain products, including surgical gowns and silicon-based devices.

Illinois Senate Environment & Conservation Chairman Sen. David Koehler, a Democrat, said he'll meet with other representatives and stakeholders tomorrow "to see if we can come to some agreement on putting a bill together before the end of the veto session."

"Could a ban on medical instrument cleaners spark a public health crisis?" originally appeared in Crain's Chicago Business.