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.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 10088 Introduced in House (IH)]

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119th CONGRESS 2d Session H. R. 10088

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.

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IN THE HOUSE OF REPRESENTATIVES

August 13, 2026

Mrs. Foushee introduced the following bill; which was referred to the Committee on Energy and Commerce

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A BILL

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 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. <all>