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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            August 13, 2026

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

_______________________________________________________________________

                                 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.
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