The Environmental Protection Agency (EPA) recently proposed a new mandate to update Clean Air Act standards for ethylene oxide (EO) emitted into the air during sterilization processes. The proposal aims to cut emissions by 80% by revising and establishing new standards for sterilization chamber vents and aeration room vents, specifically addressing EO emissions from chamber exhaust vents and room air emissions.
The proposal also includes requirements for facilities to monitor pollution control equipment and conduct performance testing for key components of the sterilizing process. Additionally, the proposal adds provisions for electronic reporting of performance test results and reports, performance evaluation reports, and compliance reports.
While this proposal has significant environmental benefits, it may pose challenges for medical device manufacturers. The new mandate requires that units cannot be moved from the sterilization chamber to an aeration chamber because the EO is being released into the environment before reaching the aeration chamber. Companies must ensure they have enough scrubbers to accommodate the gas release and conduct all sterilization processes in one room.
This new mandate is a hot issue for medical device manufacturers using ethylene oxide, as current sterilization houses may not be able to accommodate these new rules. Some may need to stop services to build new chambers before moving forward, slowing down their business models.
While the proposed changes are necessary to reduce emissions and protect public health, companies will have to work to comply with the new standards. With the right steps taken to adhere to the new standards, medical device manufacturers can continue to produce products that are safe for both patients and the environment.
If you have questions about the medical incubation process and want to learn more, book a time to meet with our CEO Jason Scherer.
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