ARTICLE SUMMARY:
The Environmental Protection Agency published its hotly anticipated final ethylene oxide sterilization emissions rule with updates from a 2023 proposal that tries to respond to industry and FDA concerns about medical device shortages. Meanwhile, an important parallel EtO policy is still pending.
New US regulations governing ethylene oxide (EtO) emissions from commercial sterilizers to curb cancer risks will give facilities more time to transition and some more flexibilities in how they comply to the more stringent requirements compared to what the Environmental Protection Agency had proposed last year. Device firms are now pouring over the details of EPA’s final EtO rule, issued March 14, to gauge how far these revisions will go to head off the massive supply chain disruptions they warned of based on the proposed rule.
“There are three broad areas we have emphasized throughout the rulemaking: adequate time to implement, flexibility in technologies to remove emissions, and the ability to achieve EPA targets that would not force resubmission of medical devices for FDA approval,” AdvaMed’s CEO Scott Whitaker told Market Pathways. “We will be reviewing the rule through that lens and remain hopeful that these changes will not have a negative impact on the healthcare system or the patients we serve."
