FDA Official: Supply Chain Could Suffer If EtO Sterilizers Close

By Luke Zarzecki / May 17, 2024 at 6:40 PM
An FDA official said the potential of sterilizers who contract with medical device manufacturers closing their doors in the wake of new restrictions on the chemical ethylene oxide (EtO), often used to sterilize devices, is worrisome for the medical supply chain. “There is a finite amount of overall sterilization capacity through any method in the U.S. or even globally, and those devices would have to go somewhere,” Ryan Ortega, regulatory policy advisor at the Center for Devices and Radiological Health,...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.