What’s happening: The U.S. Environmental Protection Agency (EPA) released a final rule limiting carcinogen ethylene oxide (EtO) emissions for commercial medical device sterilization facilities. According to EPA, the new rule is intended to lower the cancer risk in communities surrounding these facilities to below the benchmark safety threshold.
What else to know: Hospitals and medical device suppliers have raised concerns that the updated regulations could cause a supply chain disruption for certain medical devices because many medical devices are sterilized with EtO. The new rule addresses these concerns while maintaining the goal of overall reduction of EtO emissions by 90%.
The final rule has loosened requirements for compliance, allowing more time to adapt and ensure adequate amounts of devices are available to treat patients. EPA claims that no facilities will close due to the new regulations.
Key components of the rule include:
- 2.5 to 3.5 years for commercial sterilizing facilities to come into full compliance, with further flexibility at the discretion of the president of the United States
- Continuous monitoring of EtO emissions that will be reported to EPA quarterly and made public
- Stricter emission reduction requirements for facilities that use more EtO
EPA’s chemical safety office is also working on regulations for workers’ protections at sterilizing facilities.