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.
This legislative proposal mandates the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to undertake a comprehensive study. The primary objective is to assess the potential for expanding the safe and effective use of reprocessed single-use devices , with patient safety and infection prevention serving as the primary criteria for evaluation, stratified by risk category and clinical use. The study is specifically tasked with evaluating both opportunities for and barriers to the expanded use of qualified third-party reprocessors . It will delve into various aspects, including existing Food and Drug Administration pathways for reprocessing, the operational feasibility of such practices—considering sterile processing capacity, staffing, and quality assurance—and the financial and environmental returns, such as waste reduction and cost savings, alongside potential added burdens. Furthermore, the study must examine issues related to liability and accountability in cases of device failure or patient harm. It requires consultation with a wide range of stakeholders, including non-Federal entities like hospitals and industry representatives, and Federal entities such as the FDA, CDC, and CMS. A detailed report summarizing the study's findings, including a list of devices with reprocessing potential and recommendations for future programs, must be submitted to Congress within one year of the bill's enactment.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Introduced in House
Referred to the House Committee on Energy and Commerce.
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.
USA119th CongressHR-10088| House
| Updated: 8/13/2026
This legislative proposal mandates the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to undertake a comprehensive study. The primary objective is to assess the potential for expanding the safe and effective use of reprocessed single-use devices , with patient safety and infection prevention serving as the primary criteria for evaluation, stratified by risk category and clinical use. The study is specifically tasked with evaluating both opportunities for and barriers to the expanded use of qualified third-party reprocessors . It will delve into various aspects, including existing Food and Drug Administration pathways for reprocessing, the operational feasibility of such practices—considering sterile processing capacity, staffing, and quality assurance—and the financial and environmental returns, such as waste reduction and cost savings, alongside potential added burdens. Furthermore, the study must examine issues related to liability and accountability in cases of device failure or patient harm. It requires consultation with a wide range of stakeholders, including non-Federal entities like hospitals and industry representatives, and Federal entities such as the FDA, CDC, and CMS. A detailed report summarizing the study's findings, including a list of devices with reprocessing potential and recommendations for future programs, must be submitted to Congress within one year of the bill's enactment.