EPA’s Ethylene Oxide Proposed Rule Could Disrupt Device Sterilization

Proposed new rule from the Environmental Protection Agency meant to limit ethylene oxide exposure to workers in sterilization plants Medical device manufacturers are concerned about potential delays and shortages.

EPA tighter controls proposed on facilities for the safety of workers Exposure to cancer causing chemicals. Ethylene oxide is used to clean spices, make antifreezes, manufacture textiles, and as an insecticide. The carcinogen also disinfects 20 billion medical devices annually, including syringes, catheters, infusion pumps, surgical kits and pacemakers. Food and Drug Administration has been piloting option for ethylene oxide to sterilize medical equipment but none have the scale to convert the carcinogen without disrupting the supply chain.

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

According to the EPA, the proposal would apply to 86 commercial sterilizers nationwide, some of which are already regulated. Those who will not have 18 months to comply with the regulation. The federal agency estimates that the changes will reduce ETO emissions from these facilities by 80%.

AdvaMed, a trade association that represents medical technology companies, said the timeline for installing the emissions-tracking technology is too short and could affect the steady flow of medical devices. AdvaMed President and CEO Scott Whittaker said the proposed rule disregards pre-existing safeguards and increases the risk of EtO exposure for employees. He added that manufacturers are still grappling with the COVID-19 pandemic and the additional regulations could make it worse.

“Infection control is paramount in patient care. Because ETO sterilization is at capacity, even closing some sterilization facilities could result in a shortage of supply affecting patients,” Whittaker said in a statement. “Placement of a pacemaker to stabilize the heart or cataract surgery to restore vision may take longer.”

Previous attempts by state agencies to regulate the colorless gas have been delayed as manufacturers were forced to divert inventory to other plants and triage equipment through the bottleneck distribution process. In 2019, ending According to the FDA, a Sterigenics facility in Willowbrook, Illinois resulted in a shortage of a particular brand of breathing tube for children.

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

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

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

Diana Cebello, assistant professor of environmental and occupational health sciences at the University of Washington, said the rule marks a rare collaboration between federal agencies developing rules on workplace exposure to the cancer-causing chemical. 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 those who are exposed to it over a long period of time. It can also cause birth defects and neurotoxicity, Cebello said.

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

Source link

Leave a Comment