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While it is understood that medical devices must be correctly reprocessed to avoid transmission of infections to patients, this is sometimes difficult to achieve. A longstanding concern among healthcare personnel responsible for reprocessing reusable medical devices is that reprocessing instructions are often inadequate or do not take into account the cleaning, disinfection and sterilization processes commonly available in healthcare facilities.
Two new publications from the Association for the Advancement of Medical Instrumentation provide valuable information for medical device manufacturers who produce devices intended to be reprocessed in healthcare facilities. The first publication, TIR 12:2004, Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 2nd edition, addresses design considerations and provides information on decontamination, disinfection and sterilization processes commonly used in healthcare facilities. This document will assist manufacturers in validating the reprocessing procedures they recommend and will guide them in choosing reprocessing protocols that can be performed adequately in healthcare facilities. The second document, ANSI/AAMI/ISO ST81:2004,...