Z314.0 Medical Device Reprocessing – General Requirements Has Now Been Published

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Z314.0 Medical Device Reprocessing General Requirements

This Standard sets out requirements for health care settings to establish, document and maintain their own policies and procedures for the reprocessing of medical devices, forming a unique internal QMS. These policies and procedures are based on several inputs, including government regulation, national standards and the specific requirements that make up the quality system of the individual organization. The main function of a QMS is to establish consistency and control of the required processes and documentation in order to produce quality products. A QMS for MDRD requires management of the reprocessing area to be considered analogous to that of a manufacturing facility. The products of the MDRD are therefore decontaminated and sterilized medical devices (or any other output that would be a result of following controlled processes within the MDRD). The MDRD referenced in this Standard refers to any reprocessing area, be it in a hospital, clinic, or anywhere within a health care setting where reprocessing occurs. The MDRD can be a simple one-person organization or a sophisticated multi-site department under a single management.

For those that might wish to purchase a copy, please see the following link: http://shop.csa.ca/en/canada/sterilization/z3140-13/invt/27035312013.