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.
Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Official summary
No official summary is available in the imported record yet.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 20, 2026. Consult Congress.gov for the current record.
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PlainBill explanation
Read the proposal in plain language
AI-generated · Source-checked by AI · Oct 22, 2026
Based on the full Introduced in House · 2026-08-13 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
What it would do
This proposal would require federal health officials to study whether medical devices intended for a single use could safely be prepared for reuse. The study would examine patient safety, hospital operations, costs, environmental impacts, and the role of outside reprocessing companies. It would require a report to Congress within one year after enactment, including recommendations; the bill itself would not authorize expanded reuse.
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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.
(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;
The proposed study would make patient safety and infection prevention its primary criteria, examining devices separately by risk category and clinical use. It would consider patient outcomes, device performance, and validated limits on how many times a device can be reprocessed.
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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.
The study would examine existing Food and Drug Administration routes for reprocessing, including where current rules are sufficient and where barriers exist. It would compare outside reprocessors with hospitals doing the work themselves, assess opportunities and barriers for qualified outside reprocessors, and consider contractual or technical obstacles.
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the Secretary shall evaluate opportunities for, and barriers to, the expanded use of qualified third-party reprocessors.
(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;
The study would assess practical requirements, including sterile processing capacity, staffing, equipment, records of who handles devices, tracking, and quality checks. It would also consider collection and transportation arrangements and the share of collected devices that can actually be reprocessed.
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(3) the operational feasibility of reprocessing single-use devices, including sterile processing capacity, staffing, equipment, chain of custody, tracking, and quality assurance;
The study would assess financial and environmental results over devices' full life cycles. It would weigh waste reduction and cost savings alongside additional labor, investment, and compliance burdens; these are subjects for investigation, not established benefits.
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(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;
Health officials would have to seek input from hospitals, supply chain leaders, infection prevention and sterile processing organizations, clinicians, and appropriate industry representatives. They would also seek input from federal entities, including the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare & Medicaid Services.
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(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.
The proposal would use the existing definitions of “device,” “reprocessed,” and “single-use device” in section 201 of the Federal Food, Drug, and Cosmetic Act.
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(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).
Within one year after enactment, the Secretary would have to report the study results to Congress. The report would list devices considered potentially suitable for reprocessing, identifying those already legally marketed for reprocessing, those supported by sufficient evidence, and those needing further research.
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(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;
The report would recommend programs and activities for reprocessing, including the use of qualified outside reprocessors, appropriate cleaning and sterilization technology, quality checks and tracking systems, and infection prevention controls.
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(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.
The supplied actions snapshot, updated August 20, 2026, records introduction in the House and referral to the House Committee on Energy and Commerce on August 13, 2026.
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Source snapshot updated 2026-08-20T13:31:00Z.
2026-08-13: Referred to the House Committee on Energy and Commerce.
2026-08-13: Introduced in House
Reviewed version: Introduced in House · 2026-08-13. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the supplied complete introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for a particular recipient or place was identified in the supplied complete introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Other targeted benefits
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow carve-out, special exemption, or preferential treatment was identified in the supplied complete introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
What this analysis cannot establish
This analysis covers the supplied complete introduced text. The actions snapshot ends August 20, 2026; it does not establish subsequent advancement, amendment, or enactment. The provisions are described as proposals.
The referenced statutory definitions are not reproduced, so their precise legal scope cannot be determined from this bundle alone.
The bundle supplies no study results establishing which devices can safely be reprocessed or whether expanded reprocessing would save money or reduce environmental impacts.
The text does not specify how third-party reprocessors would be deemed qualified. It sets a report deadline tied to enactment but provides no separate implementation schedule or termination condition.
No member requests, earmark disclosures, committee reports, or conference materials are supplied. The spending review therefore cannot establish formal earmark status beyond what the introduced text shows.
Full text preserved for this analysis. Legislative record snapshot: Aug 20, 2026. How PlainBill uses AI