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.