ANSI/AAMI ST90, Processing of health care products—Quality management systems for reprocessing in health care facilities
ST90 specifies the minimum quality management system (QMS) requirements needed for a healthcare organization to effectively, efficiently, and consistently process medical devices to prevent adverse patient events and non–manufacturer-related device failures.
“It is my hope that ST90 provides the framework and structure for device processing areas within a healthcare facility to be more effective, efficient, and consistent in their device processing processes,” said Richard Schule, director of clinical education services at Steris Corporation and AAMI Quality Systems for Device Processing Working Group co-chair. “I also hope ST90 provides technicians, supervisors, and department leadership with a systematic approach to take their department to the next level.”
Published: July 18, 2017; 50 pages
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