In March, the U.S. Environmental Protection Agency decreed a cut to sterilization chemical ethylene oxide, calling it “one of the most potent cancer-causing chemicals.”
Eliminating its use, however, isn’t so simple. Med-tech companies deploy the chemical often when cleaning their inventions and equipment before they make it to medical professionals and patients. State trade group Medical Alley, immediately responded to the ruling with concern about how this would hamper Minnesota’s many med-tech businesses.
“Ethylene oxide is used to sterilize half of all medical devices in the country, and there is currently no effective substitute in the medical field,” said Roberta Dressen, CEO of Medical Alley in the statement. “Nearly every surgery performed in a hospital uses one or more devices sterilized by ethylene oxide. America’s patients need regulations that protect our environment yet do not harm public health.”
A Brooklyn Park, Minnesota-based company believes it has a solution that will allow med-tech companies to still use ethylene oxide without exposing workers or those living near med-tech facilities to the carcinogen. Ametek Mocon makes a gas chromatograph, a device for chemical analysis, that can measure levels of ethylene oxide in the air and sound an alarm if it’s at an unsafe level.
What’s more, Ametek said its instrument has only found “very, very low levels” of the chemical in med-tech facilities with workers, per Troy Tillman, senior global product manager.
One hang-up: the EPA’s rule focuses on outdoor air conditions for commercial sterilizers, while Ametek’s device is primarily for indoor use. But Tillman said companies could use it outside to comply with the agency’s requirements that facilities install technologies, practices and procedures proven to significantly reduce ethylene oxide emissions.
Ethylene oxide is also present in the production of industrial chemicals like antifreeze. Tobacco smoke also contains it. According to the Agency for Toxic Substances and Disease Registry, part of the U.S. Department of Health and Human Services, ethylene oxide can affect a range of different organs with potential developmental, endocrine, hematological, neurological, reproductive and respiratory effects.
“There’s been a higher rate of cancer next to commercial sterilizers,” Tillman said.
According to the U.S. Food and Drug Administration, ethylene oxide sterilizes approximately 20 billion medical devices in the U.S. every year. Facilities using ethylene oxide are classified as commercial sterilizers, and the EPA lists three commercial sterilizers in Minnesota: Medtronic in Fridley, Boston Scientific in Arden Hills and Steris in Coon Rapids. Three additional metro area research and development facilities use the chemical, but the EPA rule doesn’t affect them because of their exclusion from the Clean Air Act.
While that doesn’t seem like that many, Kristie Ellickson with the Union of Concerned Scientists said her organization in concerned about the concentration since “there are several facilities that are within two to five miles of each other.” She added the EPA didn’t consider that or the cumulative effect of it.
In 2022, the EPA did identify U.S. locations with elevated cancer risks because of the emissions, and none with the highest risk were in Minnesota.
Still, Minnesota facilities will have to manage the expenses of complying with the rules. The EPA estimated its rule will lead to capital costs of $313 million for sterilizer operators. The EPA currently lists 88 commercial sterilizers in the U.S., meaning upgrade costs would average $3.6 million per facility. Shayla Powell, a spokeswoman with the EPA, said companies will have between 2 1/2 to 4 1/2 years to comply, “with the possibility of one or more two-year exemptions using the Clean Air Act’s Presidential exemption provision.”
Ametek measuring devices, which it has been making for 25 years, typically cost between $40,000 to $60,000, Tillman said, adding its largest customers are companies that do third-party sterilization work.
It’s not yet clear how large medical device manufacturers with address the new regulation. Medtronic said it was aware of the new requirements, but it is “evaluating these new requirements and considering how they may inform next steps,” per spokeswoman Erika Winkels.
Medtronic competitor Boston Scientific is also taking stock of the changes and is also evaluating “the potential effects of the new rules and requirements for compliance,” per a statement.
Beyond Ametek — founded locally as Mocon in 1963 before Pennsylvania-based Ametek acquired it for $182 million in 2017 — other businesses are seeing the demand for emission-mitigation technology as well as other non-chemical sterilization methods.
NextBeam, based in North Sioux City, S.D., deploys electron beam sterilization using radiation for medical devices, which CEO Andrew Patton said is sustainable and environmentally friendly.
“We work with very large customers who are heading down this path,” Patton said, adding he could not name the customers because of non-disclosure agreements.
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