To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to conduct a study to assess the potential for expanding the safe and effective use of reprocessed single-use devices, and for other purposes.
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Summary
This bill directs the FDA to conduct a study assessing the potential for expanding the reprocessing and reuse of single-use medical devices, with a focus on patient safety, infection prevention, and the role of third-party reprocessors. The study must examine existing FDA pathways, operational feasibility, financial and environmental impacts, and liability issues. The Secretary must report findings to Congress within one year, including a listing of devices suitable for reprocessing and recommendations for programs to enable such reprocessing.
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