ARTICLE SUMMARY:
The Trump administration delays ethylene oxide emission compliance for device companies. Excerpted from Pathways’ Picks July 23: Trump’s AI Plan, Global Reliance, Africa, Asia, and EU Updates.
President Trump on July 17 granted large commercial sterilization facilities, including those that process medical devices, an extra two years to comply with federal mandates restricting emissions of ethylene oxide. The president’s proclamation lists 39 specific facilities owned by 22 different companies, including BD, Medtronic, Cook, and Sterigenics, that will benefit from the extension. Under a 2024 Environmental Protection Agency regulation, large sterilizers had until next spring to comply with significant mandatory upgrades to their EtO emissions controls, and now they have until 2028. Trump also granted extensions for three other EPA rules on the same day, and some observers anticipate his administration might move to cancel these regulations outright. Multiple industries were pursuing lawsuits against the EtO rule, and some in the device industry maintain concerns that the mandatory upgrades could lead to device shortages if they caused facilities to go offline. Historically, EtO has been employed to sterilize about half of all sterile devices sold in the US. FDA has established programs in recent years encouraging transition away from the chemical.