The Food and Drug Administration (FDA) is announcing a public workshop to discuss factors affecting the quality of reprocessing of reusable medical devices, and FDAs plans to address the identified issues. This workshop is part of an ongoing FDA effort to address patient exposure to inadequately reprocessed reusable medical devices with the overall goal to reduce the risk of infection. Additional background about the Reprocessing of Reusable Medical Devices effort can be found at www.fda.gov/reprocessingreusabledevices1.
The purpose of the workshop is to discuss factors affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices, reprocessing methodologies, validation methodologies, healthcare facility best practices, and FDAs plans to address the identified issues. Discussion topics include:
1. What are the nature, scope, and impact of reusable medical device reprocessing problems that have been observed? What are the causes of these problems?
2. What factors or criteria to facilitate reprocessing should be considered when designing reusable medical devices? How can the design process be improved to better incorporate cleanability as a design endpoint?
3. What factors or criteria should be considered when developing reprocessing instructions and validation protocols for devices to be used in various healthcare environments (e.g., hospital, ambulatory surgical center, physicians office), based on the draft guidance document, Processing / Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling?
4. What factors or criteria should be considered by a healthcare facility when developing reusable device reprocessing procedures and quality assurance processes?
5. How should problems with reusable medical device reprocessing be identified, reported, and acted upon by industry and users?
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