EPA Conclusion On Sterilizer Could Disrupt Medical Device Supply, Companies Say

If the Environmental Protection Agency issues as final its draft conclusion that ethylene oxide can cause cancer in humans, the ability to sterilize medical devices will be disrupted, sterilization companies are telling agency advisers.

“The current draft [Integrated Risk Information System] assessment will have significant adverse impacts on the ability to sterilize healthcare products,” STERIS Corp., which specializes in infection prevention and critical care technologies, told the agency's Science Advisory Board (SAB) in comments submitted prior to a Nov. 18-20 meeting about the assessment.

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