June 29, 2023

AHA urges EPA to ensure proposed EtO standards don’t disrupt healthcare delivery

Editor's Note

In a June 27 letter, the American Hospital Association (AHA) urged the Environmental Protection Agency (EPA) “to avoid disrupting healthcare delivery through the unintentional fracturing” of the medical device supply chain with its proposed ethylene oxide (EtO) standards.

The EPA proposes:

  • reducing EtO emissions by 80%
  • adding new requirements for continuous monitoring of EtO emissions at commercial sterilization facilities
  • updating standards focused on worker protection.

Currently EtO is used to sterilize approximately 50% of medical devices, many of which cannot be effectively or efficiently sterilized using other methods.

The AHA notes that it is concerned that the EPA’s proposed 18-month implementation timeline is “too aggressive and could result in significant disruption to the supply chain, leading to decreased sterilization capacity and supply availability across the country.”

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