AHA urges EPA to ensure ethylene oxide standards don’t disrupt supply chain

Commenting yesterday on the Environmental Protection Agency’s proposed standards for ethylene oxide use to sterilize medical devices, AHA encouraged the agency to give commercial sterilization facilities sufficient time to comply with any final standards to protect access to safe and sterile medical devices for patient care.
  
“We recognize and support the agency’s critical role of protecting the environment but urge caution and thoughtfulness in EPA’s approach to avoid disrupting health care delivery through the unintentional fracturing of the already fragile medical device supply chain,” AHA wrote. “… With device sterilization capabilities already at or near capacity across the country, we strongly encourage the agency to consider employing its traditional three-year implementation timeline to the standards if made final. This will allow these facilities more time to come into compliance prior to enforcement in an effort to help prevent the closure, temporary or permanent, of any of these facilities.”