12 April 2023 | Wednesday | Regulatory
Image Source : Public Domain
The Environmental Protection Agency (EPA) today released its proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act. The EPA also released its proposed update of EtO registration as a sterilant under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). AdvaMed, the leading global trade association for medtech, represents more than 450 companies supplying the sterile medtech upon which Americans depend. Scott Whitaker, AdvaMed president and CEO, made the following comment on the EPA action.
"This issue is critical for patients, and as a result, the stakes are high. Ethylene oxide sterilization facilities are at capacity. As the FDA recognizes, many medical devices simply cannot be sterilized by another method. If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short.
"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."
Whitaker continued: "Medical device sterilization is only half of 1 percent of all commercial EtO use. The process now sterilizes half of all medtech, 20 billion devices, in the United States each year. It's the only effective, viable sterilization method for heat- or moisture-sensitive materials. Americans visit the doctor one billion times a year. They're admitted to the hospital 33.4 million times a year. 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. The placement of a heartbeat-stabilizing pacemaker or eyesight-restoring cataract surgery might take much longer. The FDA shares the concern of supply disruptions.
"Two specific items cause immediate concern. One, 18 months to implement the NESHAP requirements is much too short. It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic.
"Two, it appears the FIFRA preliminary interim decision fails to account for the most current science as well as the best practices on employee safety medtech employs, a concern long raised by many in the scientific community amid calls for third-party expert review of the EPA's risk assessment. The EPA's characterization of employee risk appears to overstate the risk and disregard the strong employee protections already in practice.
"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. 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."