H.R. 10088

119 HR 10088 IH: 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.
 U.S. House of Representatives
 2026-08-13
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 EN
 Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
 I  119th CONGRESS  2d Session  H. R. 10088  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.
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.