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119-hr-10088119th Congress

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.

Sponsored By: Representative Foushee, Valerie P. [D-NC-4]

Introduced

Summary

This bill would direct HHS to study whether expanding the safe, effective reprocessing of single-use medical devices is practical. The study would prioritize patient safety and infection prevention while weighing clinical, operational, financial, environmental, and legal factors.

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  • Patients: The study would prioritize infection prevention and examine clinical outcomes and device performance for reprocessed items.
  • Hospitals and sterile processing staff: It would assess operational feasibility, including sterile processing capacity, staffing, equipment, chain of custody, tracking, and quality assurance.
  • Third-party reprocessors and in-house programs: The study would compare roles, opportunities, and barriers for qualified third-party reprocessors versus in-house hospital reprocessing.
  • Costs and environment: It would evaluate waste reduction, cost savings, and full lifecycle financial and environmental impacts of reprocessing.
  • Liability and accountability: The study would analyze legal and liability issues if a reprocessed device fails or causes patient harm.
  • Reporting and guidance: HHS would be asked to report to Congress within one year of enactment listing devices suitable for reprocessing and recommending programs, technologies, and infection control measures.

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Bill Overview

No Economic Impacts Identified for this Bill

Sponsors & CoSponsors

Sponsor

Foushee, Valerie P. [D-NC-4]

NC • D

Cosponsors

There are no cosponsors for this bill.

Roll Call Votes

No roll call votes available for this bill.

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