1. Reprocessing of single-use devices

(a) Study - The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (in this section referred to as the "Secretary"), shall conduct a study to assess the potential for expanding the safe and effective use of reprocessed single-use devices.

(b) Primary criteria - In conducting the study under subsection (a), the Secretary shall ensure that patient safety and infection prevention are the primary criteria used in examining the potential for reprocessing single-use devices, with stratification by risk category and clinical use.

(c) Focus on third-Party reprocessors - In conducting the study under subsection (a), the Secretary shall evaluate opportunities for, and barriers to, the expanded use of qualified third-party reprocessors.

(d) Contents - In conducting the study under subsection (a), the Secretary shall examine, at a minimum—

(1) existing pathways of the Food and Drug Administration for the reprocessing of single-use devices, including instances in which current rules are sufficient and instances in which barriers exist;

(2) the role of third-party reprocessors of single-use devices versus in-house hospital reprocessing;

(3) the operational feasibility of reprocessing single-use devices, including sterile processing capacity, staffing, equipment, chain of custody, tracking, and quality assurance;

(4) the financial and environmental return of reprocessing single-use devices, taking into consideration waste reduction, cost savings, and any added labor, capital, or compliance burden; and

(5) issues related to liability and accountability if a reprocessed single-use device fails or contributes to patient harm.

(e) Considerations - In conducting the study under subsection (a), the Secretary shall consider, with respect to the reprocessing of single-use devices—

(1) clinical outcomes and device performance;

(2) validated reprocessing-cycle limits;

(3) collection and transportation logistics;

(4) the percentage of collected devices that can be reprocessed;

(5) contractual or technical barriers; and

(6) full lifecycle financial and environmental impact.

(f) Consultation - In conducting the study under subsection (a), the Secretary shall seek input from—

(1) non-Federal entities, including hospitals, supply chain leaders, infection prevention organizations, sterile processing organizations, clinicians, and appropriate industry representatives; and

(2) Federal entities, including the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare & Medicaid Services.

(g) Definitions - In this section, the terms "device", "reprocessed", and "single-use device" have the meanings given such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

(h) Report to Congress - Not later than 1 year after the date of enactment of this Act, the Secretary shall transmit to Congress a report on the results of the study, including—

(1) a listing of single-use devices that the Secretary determines have the potential for reprocessing, including an identification of—

(A) devices currently legally marketed for reprocessing;

(B) devices for which reprocessing is supported by sufficient evidence; and

(C) devices for which reprocessing requires further research; and

(2) recommendations for programs and activities to provide for such reprocessing, including the use of—

(A) qualified third-party reprocessors;

(B) appropriate cleaning and sterilization technology;

(C) quality assurance and tracking systems; and

(D) infection prevention controls.