Biomedical Instrumentation &Technology 325 STANDARDS & REGULATORY WATCH ST79: And Then There Was One

A AMI’s newest recommended practice, Compre-hensive guide to steam sterilization and sterilityassurance in health care facilities (ANSI/AAMI ST79:2006) is a breakthrough standard in terms of its scope, contents, and how AAMI plans to maintain it. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorpo-rated into ST79), it truly is a com-p r e h e n s i v e guideline for all steam steriliza-tion activities in healthcare facili-ties, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization. Four-Phase System Saturated steam under pressure is one of the oldest methods used in healthcare facilities to sterilize medical devices. Because this method has been available for many years, it is thought to be a simple process–one that is well understood and controlled. However, the efficacy of any sterilization process, including saturated steam, depends on a consistent system for: 1) lowering and limiting bioburden before sterilization 2) properly preparing items for sterilization 3) selecting the appropriate sterilization parameters, and 4) establishing and implementing controls to maintain the sterility of sterilized items until they are used. These four critically interdependent phases provide the framework for ST79. For a listing of specific areas covered in the recommended practice, see sidebar “Ke