Sponsor
Valerie Foushee
Representative · D-NC
Representative · D-NC
The bill expands and clarifies reuse of eligible single‑use medical devices to lower costs, reduce waste, and improve supply resilience, but those gains depend on strong safety controls, clear liability rules, and covering compliance costs to avoid increased infection risk and uneven benefits.
Hospitals and health systems (and ultimately taxpayers/insurers) could pay less for devices because eligible single-use devices can be safely reprocessed, lowering purchase expenses and reducing healthcare spending.
Patients — including those with chronic conditions and Medicare beneficiaries — could face fewer device shortages and better access to care because expanded reprocessing would improve supply resilience.
The environment could benefit because expanded reprocessing reduces waste from single-use devices, lowering healthcare-sector environmental footprint.
Patients (and healthcare workers) could face higher infection or safety risks if reprocessing is done improperly or if validated cycle limits and patient-safety controls are insufficient.
Patients harmed by reprocessed devices may have unclear legal accountability and difficulty obtaining remedies if liability and responsibility are not clearly defined.
Hospitals and third-party reprocessors (including small businesses) could face substantial added labor, equipment, and compliance costs to meet sterilization, tracking, and regulatory requirements, offsetting some savings.
Based on analysis of 1 section of legislative text.
Requires HHS/FDA to study expanding safe reprocessing of single‑use medical devices and report recommendations to Congress within one year.
Official title: 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.
Introduced August 13, 2026 by Valerie Foushee · Last progress August 13, 2026
Requires HHS (through FDA) to study whether and how single-use medical devices can be safely and effectively reprocessed, with patient safety and infection prevention as the top priorities. The agency must evaluate clinical, operational, legal, financial, and environmental factors, seek outside input, and report to Congress within one year listing devices with reprocessing potential and recommending programs, technologies, and quality controls to enable safe reprocessing.