Why is carcinogen ethylene oxide used to sterilize medical devices?

Frunk’s treatments went as planned and the cancer never returned. It wasn’t until 2018, when the EPA began outreach to communities designated high-risk for EtO exposure, that she learned the possible cause of her cancer.

She is now one of more than 800 people in Illinois who have filed personal injury lawsuits against Sterigenics for its chemical emissions, which they say caused their cancers.

A Cook County, Illinois, jury decided the first such case Sept. 19, and awarded the plaintiff $363 million. Sue Kamuda, 70, alleged she developed breast cancer after living one-third of a mile from the plant for 37 years. She also alleged her son, Brian Kamuda, was diagnosed with non-Hodgkin’s lymphoma in 2021 because he grew up there. Their suit marked the beginning of a long legal battle regarding whether companies such as Sterigenics can be held liable in civil court for increased cancer rates in communities where it operated. [This paragraph has been updated to reflect the outcome of this lawsuit, which was announced after the print edition of Modern Healthcare went to press.]

Other states are following Illinois. In Georgia, the Environmental Protection Division started monitoring EtO levels near sterilization plants and requesting stricter emissions controls. Facilities run by medical device manufacturers Sterigenics and Becton Dickinson signed consent orders in 2019 to temporarily close their plants in the state to improve emission protections and conduct air testing.

These companies have since faced dozens of lawsuits by Georgians who allege their operations caused cancer. Georgia regulators also found what’s known as fugitive emissions in a warehouse where manufacturers sent medical devices after being sterilized, which raised alarms about a new source of ethylene oxide release not previously considered.

A facility in Grand Rapids, Michigan, run by medical device manufacturer Viant, was shut down and fined in December 2019 by the Michigan Department of Environmental Quality after the state discovered fugitive emissions in a parking lot near the facility that exceeded the allowable safety limits.

Last year, New Mexico Attorney General Hector Balderas (D) sued Sterigenics for emissions at a facility in San Teresa that opened in 1989. The site sterilized 2.5 million medical products every day, the company disclosed in legal filings. If it were to shut down, there wouldn’t be enough global capacity to make up the work, said Heather Mallinckrodt, associate vice president of contract and program services at consulting firm Vizient, which does business with companies that sterilize medical products, including Becton Dickinson.

“When [health systems] can’t get those products, they may have to delay a procedure. They may have to use an alternate product, which the clinicians aren’t as familiar with,” Mallinckrodt said.

Amid the disruption, manufacturers have had to triage the release of medical devices through a bottlenecked sterilization process. Devices for the most high-risk procedures and illnesses are prioritized, which threatens shortages of other products. Manufacturers have started to bring sterilization in-house to better control their inventory, Mallinckrodt said.

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