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.

This bill would require the Food and Drug Administration (FDA) to study whether medical devices labeled for single use could be safely cleaned and reused more widely. The study must treat patient safety and infection prevention as the main criteria and look at the role of outside companies that reprocess devices compared with hospitals doing it themselves. It must also examine current FDA rules, staffing and equipment needs, costs and environmental effects, and who is responsible if a reprocessed device causes harm. The FDA must consult hospitals, clinicians, industry, and other federal agencies, and report its findings and recommendations to Congress within one year.

Full text and official record on Congress.gov

Sponsors

• Valerie P. Foushee Democrat sponsor
• 0 cosponsors