Standardization News

ASTM International’s committee on medical and surgical materials and devices (F04) approved a new guide that seeks to improve the cleaning of medical devices. The standard provides methods for simulated soiling of reusable medical devices for the purpose of improving cleaning instructions.

The guide (F3293) offers methods for how to identify clinically relevant areas of the device to soil, time allowed for the soil to dry, and other procedures.

“This provides guidance on applying test soils to medical devices to simulate clinical use,” says ASTM International member Ralph Basile, vice president of marketing and regulatory affairs, Healthmark Industries Co.

Basile noted 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.

Medical device manufacturers, testing labs, and regulatory agencies will be the primary users of this standard. Healthcare facilities might also find it helpful to better understand how manufacturers validate their cleaning instructions.