The Environmental Protection Agency, on April 11, proposed new regulations to reduce exposure to ethylene oxide (EtO), which include more stringent air emission standards and protections for workers who are exposed to EtO when sterilizing medical devices.
The proposed standards are estimated to cut EtO emissions from commercial sterilization facilities by 80% per year.
Although many facilities have already taken steps to reduce emissions, the proposal will require all 86 existing facilities and any new facilities to comply with the stricter controls.
All commercial sterilizers also will be required to use advanced monitoring methods to confirm that these controls are operating effectively, and all facilities will be required to report results to the EPA twice per year.
The EPA is also proposing to increase control measures on the use of EtO in the proposed interim decision that will reduce the amount of EtO used for medical device sterilization, while meeting standards for sterility assurance, as well as mandating personal protective equipment when EtO is used.
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