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.
- Sponsor
- Rep. Foushee, Valerie P. [D-NC-4]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Aug 13, 2026
Bottom line
H.R. 10088 mandates an FDA study to explore the potential for greater use of reprocessed single-use medical devices, aiming to balance patient safety with cost savings and environmental benefits.
What it actually does
This bill directs the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to conduct a comprehensive study on expanding the safe and effective use of reprocessed single-use medical devices. The study must prioritize patient safety and infection prevention, examine operational, financial, environmental, and liability aspects, and focus on the role of qualified third-party reprocessors. A report with findings and recommendations is due to Congress within one year of enactment.
Proponents argue
Supporters argue that expanding the safe reprocessing of single-use medical devices could significantly reduce healthcare costs, decrease medical waste, and improve supply chain resilience without compromising patient safety. They believe a thorough FDA-led study is essential to identify best practices, address existing barriers, and develop clear guidelines for wider adoption, particularly leveraging the expertise of qualified third-party reprocessors.
Opponents contend
Opponents might raise concerns about potential risks to patient safety if reprocessing standards are not rigorously maintained or if devices are reprocessed beyond their validated limits. They may also argue that the liability framework for reprocessed devices is complex and could expose hospitals or reprocessors to increased legal risks. Some may also question the true cost savings versus the investment required for robust reprocessing infrastructure and oversight.
The bill is very short and clear, allowing for a quick and thorough understanding of its provisions.
Section 1(a)
Directing a Study on Expanded Use of Reprocessed Single-Use Devices
This provision mandates that the Secretary of Health and Human Services, through the FDA, conduct a study to evaluate how the safe and effective use of reprocessed single-use medical devices can be expanded. The study is intended to explore the feasibility and implications of increasing the practice of cleaning, sterilizing, and reusing devices originally designed for one-time use.
Supporters argue
Supporters argue that a dedicated study is crucial for evidence-based policymaking, ensuring that any expansion of reprocessing is grounded in robust safety data and operational feasibility. It provides a structured approach to identify opportunities for cost savings and environmental benefits without compromising patient care.
Critics contend
Critics might argue that such a study could be a precursor to policies that might inadvertently compromise patient safety by encouraging the reuse of devices where risks are not fully understood or managed. They might also suggest that existing FDA regulations are sufficient and a new study is redundant or delays necessary action.
Tradeoffs
This provision balances the desire for cost reduction and environmental sustainability in healthcare against the paramount need to maintain and enhance patient safety and prevent infections.
Section 1(b), (c), (d), (e), (f)
Defining the Scope and Methodology of the Reprocessing Study
This set of provisions outlines the specific parameters for the FDA's study. It mandates that patient safety and infection prevention are the primary considerations, with a focus on third-party reprocessors. The study must examine existing FDA pathways, operational feasibility, financial and environmental impacts, and liability issues. It also requires consideration of clinical outcomes, reprocessing-cycle limits, logistics, and consultation with various federal and non-federal stakeholders.
Section 1(h)
Mandating a Report to Congress with Findings and Recommendations
This provision requires the Secretary to submit a report to Congress within one year of the bill's enactment. The report must detail the study's results, including a list of single-use devices suitable for reprocessing (categorized by current market status, evidence, or need for further research) and specific recommendations for programs and activities to facilitate such reprocessing, covering technology, quality assurance, and infection control.