Process and Challenges associated with Medical Device Reprocessing | HCL Whitepaper

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Medical devices categorized as Reusable needs to be appropriately cleaned and sterilized be utilized for procedures as applicable. Improper practices of reprocessing will have serious health impacts. Applicable standards of the specific geographies to be adopted to prepare and validate the reprocessing instructions to get the product approved to be available in those specific geographies. The instructions need to be clear and executable up to the level of the reprocessor/the person involved in reprocessing. It should be user friendly and shouldnt cause any harm to the person involved in reprocessing. Our experience in performing a reprocessing validation from the starting point up to the in field testing of the prepared instructions, had various challenges which are all summarized in this WP will help to provide knowledge and understanding for validating a reusable medical device that will attain the customer's satisfaction.  The white paper narrates about Reprocessing of Reusable Medical Devices as per the requirements of Regulatory Bodies. The information in the WP will support to understand and generate a possible validation process for the medical devices provided by the customers. The reprocessing validation for reusable devices is a major requirement to be captured in the IFU of the device.