Medical device manufacturers raise public health concerns over EPA Ethylene Oxide value

Feb. 14, 2020

The Advanced Medical Technology Association (AdvaMed) this week urged the U.S. EPA to reassess its risk assessment value for ethylene oxide (EtO), arguing the threshold is neither practical nor is it based on the latest science, and pursuing it could pose an increased risk to public health through supply chain and distribution threats.

“EtO is vital to the continued availability of tens of billions of safe and effective medical devices every year, and the medical technology industry is committed to its safe and responsible use as we look for alternatives and ways to reduce EtO emissions,” said AdvaMed President and CEO Scott Whitaker. “However, EPA’s EtO risk assessment standard is unworkable and not based on the best available science. The agency’s failure to address these valid scientific concerns surrounding their value threatens not only the medical technology supply chain but the tens of millions of American patients that rely on EtO-sterilized devices. We ask the agency to follow its own scientific recommendations and develop a revised EtO risk assessment standard that will effectively protect the public health and not disrupt patient access to needed medical technology.”  

In comments on EPA’s advance notice of proposed rulemaking (ANPRM) on EtO standards for sterilization facilities, AdvaMed argues that EPA’s 2016 Integrated Risk Information System (IRIS) value for EtO should not be used for regulatory purposes as IRIS:

  • "Is inconsistent with a variety of recommendations made by the National Academy of Sciences and by EPA's own risk assessment guidance";
  • "Defies science and common sense in the context of everyday human exposures, both endogenous and exogenous"; and because of
  • "The unacceptable public health risk-risk tradeoffs involved."

The Advamed letter.

Advamed release

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