New Environmental Protection Agency proposed rule to limit exposure to ethylene oxide for workers in fumigation plants has been Medical device manufacturers worry about delays and potential shortages.
EPA recommends tighter controls on facilities to protect workers from exposure to cancer-causing chemicals. Ethylene oxide is used to clean spices, produce antifreeze, in textile manufacturing, and as an insecticide. Carcinogens also disinfect 20 billion medical devices annually, including syringes, catheters, infusion pumps, surgical kits, and pacemakers. The Food and Drug Administration has piloted alternative methods of ethylene oxide for sterilizing medical devices, but none have scaled up to replace carcinogens without disrupting the supply chain.
The rule would require sterilization facilities to equip their facilities with technology to monitor levels of ethylene oxide in the air and require workers to wear personal protective equipment in areas where chemicals are detected. The EPA also recommends reducing the concentration of EtO used in medical device sterilization processes.
According to the EPA, the proposal would apply to 86 commercial sterilizers nationwide, some of which already have controls. Those who don’t will have 18 months to comply. The federal agency estimates these changes will reduce EtO emissions from these facilities by 80 percent.
AdvaMed, a trade association representing medical technology companies, said the time to install emissions-monitoring technology was too short and could affect a steady flow of medical equipment. The proposed rule ignores already in place safety measures and overstates the risk of EtO exposure to employees, said Scott Whitaker, president and CEO of AdvaMed. He said: “Manufacturers are still reeling from the COVID-19 pandemic and additional regulations could make the situation worse.
“Infection control is paramount in patient care. As EtO’s disinfection process is at full capacity, closing even some disinfection facilities could cause supply shortages affecting patients,” Whitaker said in a statement. “Pacemaker placement or cataract surgery that restores vision may take longer.”
Previous efforts to regulate colorless gas by state agencies have caused delays as manufacturers are forced to move inventory to other plants and sorting equipment through the distribution process. stuck. According to the FDA, in 2019, the closure of a Sterigenics facility in Willowbrook, Illinois resulted in a shortage of a specific brand of breathing tube intended for children.
In a written statement, Sterigenics said many of its facilities are already equipped with emissions control measures that go beyond current regulatory requirements. The company also said the EPA’s proposed rule overstates the risks associated with exposure to ethylene oxide.
“The EPA’s draft proposals are based on a flawed IRIS risk assessment, overestimate the actual risks associated with levels of EO found in everyday air, and also contradict the findings.” in the real world,” a Sterigenics spokesperson wrote in an email. “Using EO to disinfect medical devices is essential to the U.S. healthcare system, and Sterigenics looks forward to continuing to work with federal and state regulators.”
According to a press release, the EPA has been working with the FDA, the Centers for Disease Control and Prevention, the Disease and Toxicology Registry, and the Occupational Safety and Health Administration on regulations.
Diana Ceballo, assistant professor of environmental sciences and occupational health at the University of Washington, said the rule marks a rare collaboration between federal agencies to develop a rule about exposure to carcinogenic chemicals in the workplace. The last action the federal government took to regulate ethylene oxide was in 2006.
This chemical is associated with a higher cancer risk for those exposed to it long-term. It can also cause birth defects and neurotoxicity, Ceballo said.
“They want to reduce emissions overall,” she said. “To do that, they have to control the workplace.”
