Standards for reprocessing have been a top priority for regulatory bodies all over the world. Active work around reusable medical devices has challenged the medical device industry to think differently from what they have been accustomed to. Updates in Medical Device Regulation (MDR), International Organization for Standardization (ISO), and Association for the Advancement of Medical Instrumentation (AAMI) alone have made a large leap in this area, bringing attention to the predicate devices used for submissions for market approval of reusable products. With technological innovations, design and functional features of reusable devices have advanced, raising the following question: Are design history files (DHFs) for reusable medical devices still valid?
This presentation covers what medical device manufacturers need to evaluate for their design history files or device portfolios for reusable medical devices to comply with current standards and expectations. The presentation also discusses the current trend of rethinking the path of single-use devices to reusable devices and the challenges 3D-printed devices bring to reprocessing.
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