Highlights from the ASTM F04 Workshop on Medical Device Cleaning Limits 2023
Committee F04 on Medical Devices sponsored a workshop on discussion setting limits for residues on medical devices during cleaning validation on May 9, 2023 in Denver, CO. The conference was organized by Stephen Spiegelberg (Cambridge Polymer Group) and Ralph Basile (Healthmark), and included presenters from testing laboratories, device manufacturers, material manufacturers, regulators, toxicologists, and cleaning […]
New Ethylene Oxide Sterilization Standards Proposed
The Environmental Protection Agency (EPA) is proposing new standards on chemicals used to sterilize medical devices, including ethylene oxide (EO/EtO), one of the more commonly used sterilants. However, ethylene oxide has recently been scrutinized due to safety concerns about workers’ EtO exposure at sterilization facilities. The EPA is proposing a decrease in the highest allowable […]