This bill directs the Secretary of Health and Human Services, through the FDA Commissioner, to carry out a study on whether the safe and effective use of reprocessed single-use medical devices can be expanded. The study must make patient safety and infection prevention the main criteria and must look at different risk categories and clinical uses. The study must evaluate third-party reprocessors, existing FDA pathways for reprocessing, in-house hospital reprocessing, operational feasibility (sterile processing capacity, staffing, equipment, chain of custody, tracking, quality assurance), financial and environmental returns (waste reduction, cost savings, and added labor, capital, or compliance burdens), and liability and accountability if a reprocessed device contributes to patient harm.
The Secretary must consider clinical outcomes, validated reprocessing-cycle limits, collection and transport logistics, the percent of collected devices that can be reprocessed, contractual or technical barriers, and full lifecycle financial and environmental impact. The study must include input from non-Federal entities (hospitals, supply chain leaders, infection prevention groups, sterile processing organizations, clinicians, and industry) and from Federal agencies (FDA, CDC, CMS). The bill uses the definitions for device terms from 21 U.S.C. 321. The Secretary must submit a report to Congress within one year after enactment. The report must list single-use devices that could be reprocessed and identify which are already legally marketed for reprocessing, which are supported by sufficient evidence, and which need more research. The report must also include recommendations for programs and activities to support reprocessing, such as use of qualified third-party reprocessors, appropriate cleaning and sterilization technology, quality assurance and tracking systems, and infection prevention controls.
If this bill becomes law, the FDA would study how to expand reprocessing of single-use devices and provide Congress a list of devices and recommendations within one year. The study would focus on keeping patients safe and preventing infections, and it would look at both hospital-based and third-party reprocessing operations. Hospitals, device reprocessors, clinicians, and others could be asked to give input to the study.
No publicly available information on costs or appropriations for conducting the study is included in the bill text.
No publicly available information.
No publicly available information.