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EPA sterilizer ruling may disrupt medical device supply

A number of companies are worried about the Environmental Protection Agency's conclusion for ethylene oxide.

Some sterilization companies are expressing concerns over an Environmental Protection Agency draft conclusion that ethylene oxide can cause cancer in humans, saying if this becomes final, the ability to sterilize medical devices will be disrupted.

According to Bloomberg BNA, STERIS Corp., told the agency's Science Advisory Board, “the current draft [Integrated Risk Information System] assessment will have significant adverse impacts on the ability to sterilize healthcare products."

The comments were submitted to the agency's Science Advisory Board prior to a meeting about the assessment.

They continued, according to the report:

"By inappropriately magnifying the risk associated with the use of ethylene oxide, users could be forced to switch to less effective, impractical alternatives with significant adverse public health consequences.”

STERIS Corp., specializes in infection prevention and critical care technologies.

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