EPA’s ethylene oxide proposed rule could disrupt device sterilization


The Environmental Protection Agency’s proposed new rule meant to limit exposure of ethylene oxide to workers in sterilization plants has medical device manufacturers worried about potential delays and shortages.

The EPA proposed stricter controls on facilities to protect workers from exposure to the cancer-causing chemical. Ethylene oxide is used to clean spices, produce antifreeze, in textile manufacturing and as a pesticide. The carcinogen also sterilizes 20 billion medical devices annually, including syringes, catheters, infusion pumps, surgical kits and pacemakers. The Food and Drug Administration has been piloting alternatives for ethylene oxide to sterilize medical devices but none have the scale to replace the carcinogen without disrupting the supply chain.

The rule would require sterilizers to equip their facilities with technology that monitors the level of ethylene oxide in the air and mandates that workers wear personal protective equipment in locations where the chemical is detected. The EPA also proposed reducing the concentration of EtO used in the medical device sterilization process.

The proposal would apply to 86 commercial sterilizers across the country, some of which already have controls in place, according to the EPA. Those who don’t would have 18 months to comply with the regulation. The federal agency estimates the changes would reduce EtO emissions from these facilities by 80%.

AdvaMed, a trade association that represents medical technology companies, said the timeline for installing the emission-tracking technology is too short and could affect the steady flow of medical devices. The proposed rule disregards safety measures already in place and overstates the risk of EtO exposure to employees, said AdvaMed president and CEO Scott Whitaker. Manufacturers are still reeling from the COVID-19 pandemic and additional regulations could make it worse, he said.

“Infection control is paramount in patient care. Because EtO sterilization is at capacity, closing even a few sterilization facilities could cause supply shortfalls affecting patients,” Whitaker said in a statement. “The placement of a heartbeat-stabilizing pacemaker or eyesight-restoring cataract surgery might take much longer.”

Previous attempts to regulate the colorless gas by state agencies have caused delays as manufacturers were forced to divert inventory to other plants and triage devices through a bottlenecked distribution process. In 2019, the closure of a Sterigenics facility in Willowbrook, Illinois resulted in the shortage of a breathing tube for children, according to the FDA.

In a written statement, Sterigenics said many of its facilities are already equipped with emission controls that go beyond current regulatory requirements. The company also said the EPA’s proposed rule overinflates the risk associated with exposure to ethylene oxide.

“The EPA’s draft proposals rely on a flawed IRIS risk assessment that overstates actual risks related to EO levels found in everyday air and also contradicts real-world findings,” a Sterigenics spokesperson wrote in an email. “The use of EO for the sterilization of medical devices is essential to the US health care system and Sterigenics looks forward to continuing to collaborate with federal and state regulators.”

The EPA worked with the FDA, the Centers for Disease Control and Prevention, the Agency for Toxic Substances and Disease Registry and the Occupational Safety and Health Administration on the regulations, according to a news release.

The rule marks a rare collaboration among federal agencies to develop a rule on workplace exposure to a chemical that causes cancer, said Diana Ceballo, assistant professor of environmental and occupational health science at the University of Washington. The last action the federal government took to regulate ethylene oxide was in 2006.

The chemical is linked to a higher risk of cancer for people who are exposed to it long-term. It also can cause birth defects and neurotoxicity, Ceballo said.

“They want to reduce emissions in general,” she said. “To do that, they have to control the workplaces.”


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