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 requires the Secretary of Health and Human Services (HHS), working through the Food and Drug Administration (FDA), to conduct a study on expanding the safe and effective reuse (reprocessing) of single-use medical devices. As part of the study, HHS must: * Focus primarily on patient safety and infection prevention across different device risk levels and medical uses. * Evaluate the potential and barriers of using qualified third-party reprocessors versus hospital in-house reprocessing. * Examine existing FDA regulatory pathways, operational requirements (like staffing, equipment, and tracking), financial and environmental impacts, liability issues, and logistical factors. * Consult with federal agencies—including the FDA, the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare & Medicaid Services (CMS)—as well as non-federal stakeholders such as hospitals, clinicians, sterile processing organizations, infection prevention groups, supply chain leaders, and industry representatives. * Submit a report to Congress no later than **1 year** after the bill is enacted. The report must categorize single-use devices based on their reprocessing potential and provide recommendations for technology, quality controls, and reprocessing programs.

* **Federal Agencies:** The Department of Health and Human Services, FDA, CDC, and CMS are required to conduct or participate in the study. * **Healthcare and Industry Organizations:** Hospitals, clinicians, sterile processing teams, infection prevention organizations, medical supply chain leaders, and third-party medical device reprocessors will be consulted for input. * **Congress:** Receives the final report and recommendations.

* **Mandated Research:** HHS must gather data and evaluate clinical, operational, legal, and financial factors related to reusing single-use medical devices. * **Reporting to Congress:** Within one year of enactment, HHS must deliver a categorized list of single-use devices (those currently marketed for reprocessing, those with sufficient evidence, and those needing more research) along with recommendations for reprocessing policies and systems. * **No Direct Policy Changes:** The bill requires research and reporting; it does not directly change current medical device regulations or require healthcare facilities to start reprocessing devices.

The provided summary does not specify any funding amounts, appropriations, taxes, or fees associated with conducting this study.

* The bill mandates a study and a report, but it does not mandate changes to current FDA regulations or create new requirements for how hospitals handle single-use devices. * The evaluation must prioritize patient safety and infection prevention above other considerations.

This bill orders federal health agencies to spend a year studying whether and how single-use medical devices can be safely cleaned and reused, culminating in a detailed report and recommendations to Congress.