ASTM International has published a new guide that aims to help improve the cleaning of medical devices.
guide was approved by ASTM International’s committee on medical and surgical materials and devices. F3293 provides methods for simulated soiling of reusable medical devices for the purpose of improving cleaning instructions. Furthermore, the guide sets out to help identify clinically relevant areas of the device to soil, time allowed for the soil to dry, and other procedures.
Ralph Basile, ASTM International member, and vice president of marketing and regulatory affairs, Healthmark Industries Co said, “This provides guidance on applying test soils to medical devices to simulate clinical use.”
Basile added that the guide includes information on the design of the device, material composition, and other challenges to cleaning the device, particularly in worst-case scenarios.
Intended primary users of the guide include medical device manufacturers, testing labs, and regulatory agencies. Healthcare facilities may also find the guide helpful to better understand how manufacturers validate their cleaning instructions.