HRS Joins Letter Urging Caution on EPA Proposal to Regulate Ethylene Oxide | Heart Rhythm Society

HRS Joins Letter Urging Caution on EPA Proposal to Regulate Ethylene Oxide

June 29, 2023 - In April, the Environmental Protection Agency (EPA) released a proposed rule, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review.  The letter, signed by several societies, urges caution given the potential unintended consequences of such a rule.

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In April, the Environmental Protection Agency (EPA) released a proposed rule, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, which can be found in its entirety via this link

The letter, signed by several societies, urges caution given the potential unintended consequences of such a rule.  HRS, joining the American College of Cardiology, the Society for Cardiovascular Angiography & Interventions, the Society of Interventional Radiology, and the Society of Thoracic Surgeons state:

"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. 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."

A copy of the full letter is available for review.