AdvaMed anticipates EtO sterilization rule, voices concern about impact on patient care

February 28, 2024
WASHINGTON, D.C. – By Friday, March 1, the Environmental Protection Agency is expected to finalize its regulation for the ethylene oxide (EtO) sterilization of 20 billion, or half, of all medical devices in the United States each year. AdvaMed President and CEO Scott Whitaker released the following statement:

“Throughout this process, we’ve been clear that the draft rule, if implemented as written, could cause facility shutdowns and closures leading to widespread delays in patient care. The FDA shares this concern. If finalized as written, EPA proposals could cause up to a 50-percent reduction in EtO sterilization capacity for the medical technologies upon which patients’ health and lives depend. We appreciate the willingness of the EPA, FDA, and other agencies to hear our perspective, and we hope the final rule is more workable because they heard us. We’ll review the regulation to see if that’s the case. As we’ve said many times, the stakes are high.”

In comments filed on the draft regulation (under the National Emission Standards for Hazardous Air Pollutants, or NESHAP,) and in numerous meetings with the EPA, FDA, Office of Management and Budget, and members of Congress, AdvaMed stressed that the medtech industry welcomes the updated rule. Whitaker also testified before Congress this past fall, where he emphasized that the industry welcomes the updated regulation but that it must be rooted in science and take into account the significant negative impact a poorly written rule would have on patient care.

The industry supports updated standards while ensuring the technology patients rely on around the clock is sterile and well-supplied. The draft rule, if implemented as written, could cause disruptions in patient care resulting from facility shutdowns and closures because sterilization is at capacity.

The industry also has noted that EtO emissions have numerous sources. EtO is a naturally occurring gas and a byproduct of common, everyday items: buses, lawn mowers, fire pits, charcoal grills, and gas generators. The gas is a building block for multiple commercial products. Medical device sterilization uses half of one percent of all commercially produced EtO. In analyzing commercial sterilizer facility emissions, the EPA estimated “worst-case scenario” public health risks. Clear understanding of sources of EtO beyond commercial sterilizers and background levels are necessary to meaningful risk assessment.