New EPA Rule Impacting Medical Device Sterilization: Strict Emissions Control, Compliance Certification, Reporting

Description

The EPA recently released its long-awaited final rule regulating EtO emissions by commercial sterilizers who use the chemical to sterilize medical equipment. The final rule, effective Apr. 5, 2024, differs significantly from the April 2023 proposed rule and results in costly restrictions and compliance obligations for covered entities.

The final rule includes stricter emissions standards for chamber sterilization vents and aeration room vents, as well as new standards for previously unregulated emissions sources such as chamber exhaust vents and room air admissions, also known as "fugitive emissions." However, the standards vary based on the size of the facility, the amount of EtO used, and the date of the startup of the source. The rule also provides for alternative compliance methods through combined emissions streams.

Additionally, the final rule changes the way commercial sterilizers will certify their compliance with emissions control requirements. The rule requires the use of EtO continuous emissions monitoring systems, with exceptions for small users of EtO, and the electronic submission of compliance reports, performance test reports, and performance evaluation reports through the EPA's Central Data Exchange.

Listen as our expert panel guides environmental practitioners through the EPA's final rule governing the use of EtO by commercial sterilizers. The panel will discuss the new emissions control standards, reporting requirements, and questions left open by the rule. The panel will also address the impact the final rule will have on covered entities and offer best practices for preparing for compliance.