WASHINGTON (CN) — New regulations announced for a toxic chemical used in medical sterilization is spurring worry among industry representatives about potential disruptions to hospital and clinical supplies.
The Environmental Protection Agency announced the proposal Tuesday, saying it intends to reduce air pollutants from manufacturers of ethylene oxide and chloroprene, while also imposing tougher regulations on commercial sterilizers that use the chemicals.
Ethylene oxide is used in the production of perfumes, lubricants and paint thinners, but is also an important chemical for sterilizing medical equipment. While that sterilization accounts for less than half a percent of all commercial ethylene oxide in the United States, it is used in half of all medical devices, more than 20 billion devices, according to AdvaMed, a medical technology association. Those devices include syringes, surgical kits, catheters, and implants like hip and knee replacements.
Warning that long-term exposure to ethylene oxide in or near a commercial sterilization facility increases the risk of cancer, the EPA said its proposal balances the need for risk reduction with “maintaining critical sterilization capabilities.” The agency said the measure implements controls that many facilities already use.
“EPA’s number one priority is protecting people’s health and safety, and we are committed to taking decisive action that’s informed by the best available science,” EPA Administrator Michael Regan said in a statement. “[The proposal] would significantly reduce worker and community exposure to harmful levels of ethylene oxide. EPA will continue to use every available tool to safeguard our nation’s communities, including workers, from exposure to toxic chemicals and to deliver important public health protections.”
The facilities would be required to use advanced source monitoring methods on emissions and report results to the EPA twice a year. The regulations would prohibit some uses of ethylene oxide if alternatives exist, such as in museums, archival settings, beekeeping, some cosmetics and musical instruments. They would also reduce the amount of time the chemical can be applied to medical devices, require engineering controls to reduce worker exposure and mandate personal protective equipment in sterilization facilities.
Facilities must be compliant within 18 months of the regulation going into effect; an expedited timeline, according to the EPA.
Tuesday’s announcement affects 86 facilities and aims to reduce their emissions by 80%.
“Many of these facilities have already taken steps to reduce emissions,” but the stricter pollution controls still require attention, the EPA said.
Some medical industry representatives feel the proposal doesn’t consider the complexity of the sterilization process. They say ethylene oxide is the only method of sterilization for many items that have electrical components, and that alternative methods such as steam cause warp or other damage.
“Many medical devices simply cannot be sterilized by another method,” Scott Whitaker, AdvaMed president and CEO, said, adding that ethylene oxide is “the only effective, viable sterilization method for heat- or moisture-sensitive materials.”
“This issue is critical for patients, and as a result, the stakes are high,” Whitaker said in a statement. “For 80 years, the medtech industry has used ethylene oxide to sterilize medical equipment. We have done so in a manner that is both safe and effective for patients and for communities and employees. If we have careful coordination with the EPA, we are confident we can deliver for all interests as these regulations are refined and finalized."
Even a slight disruption could cause problems and hurt supply chains, Whitaker predicted, noting that sterilization facilities are already at capacity .
“Medtech companies want to continue serving patients without interruption. The EPA should understand, and its regulations should reflect, that like the EPA, medtech is in the business of protecting public health,” Whitaker said. “We hope the EPA will take our comments into account and work with us on final regulations that ensure continued infection control while achieving the EPA’s goals, which we share, of protecting community members and employees.”
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