The American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI), Heart Rhythm Society (HRS), Society of Thoracic Surgeons (STS) and Society of Interventional Radiology (SIR) have shared their concerns with a proposed U.S. Environmental Protection Agency (EPA) policy that would significantly reduce the use of ethylene oxide (EtO) in U.S. sterilization facilities.
EtO, which is used for the sterilization of medical devices such as pacemakers, angioplasty balloons, cardiac catheters, stents and guiding sheaths, is considered to be carcinogenic.
The EPA’s proposal, first announced back in April, is designed to limit worker exposure to EtO. The agency believes its proposal, if finalized, would reduce EtO emissions from commercial sterilization facilities by up to 80%.
“EPA’s No. 1 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 S. Regan said at the time in a prepared statement.
While the ACC, SCAI, HRS, STS and SIR all support efforts to reduce exposure to EtO, they fear this proposal does not appear to give sterilization facilities—or the healthcare providers who rely on those facilities—enough time to adapt. The groups noted that there are “limited” alternatives in place when it comes to the sterilization of these essential devices.
“We are concerned that the proposed rule as written could result in significant disruptions to the medical supply chain and our ability to care for our patients,” the groups wrote. “We urge the EPA to work closely with the FDA and relevant stakeholders to implement updated national standards to reduce EtO emissions that provide sufficient time and flexibility for sterilization facilities to comply in order to ensure continued patient access to critical devices.”
Read the group’s comments to the EPA here.
Another voice speaks up: AdvaMed comments on EPA’s proposal
AdvaMed, the Medtech Association, shared similar concerns about the EPA’s proposal in a separate statement. For instance, the group wrote that the reductions in capacity at these sterilization facilities “will likely result in a significant disruption to patient care and risk a public healthcare crisis.”
“The proposed rules’ implementation timeframe of 18 months is impossible to meet and will exacerbate critical infrastructure shortages,” the organization added.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.