H.R. 10088: 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 bill would require the Secretary of Health and Human Services, through the FDA Commissioner, to study whether more single-use medical devices could be safely cleaned, sterilized, and used again.

What the study would look at

The study would put patient safety and infection prevention first. It would also look at different risk levels and uses of devices to see which ones might be suitable for reprocessing.

• How current FDA rules for reprocessing single-use devices work, and where those rules may already be enough or may create barriers
• The role of third-party reprocessors versus hospitals reprocessing devices themselves
• Whether reprocessing is operationally practical, including staffing, equipment, tracking, and quality control
• The financial and environmental effects, such as cost savings and reduced waste, as well as added labor or compliance costs
• Liability and accountability if a reprocessed device fails or harms a patient

Other factors the study would consider

• Clinical outcomes and device performance
• How many times a device can be reprocessed safely
• How devices would be collected and transported
• What share of collected devices could actually be reused
• Contractual or technical barriers
• Overall financial and environmental impact over the full lifecycle of the device

Who must be consulted

The Secretary would have to seek input from hospitals, supply chain leaders, infection prevention groups, sterile processing organizations, clinicians, industry representatives, FDA, CDC, and CMS.

Report to Congress

Within 1 year of enactment, the Secretary would have to send Congress a report that:

• Lists single-use devices that may be suitable for reprocessing
• Separates them into:
  • devices already legally marketed for reprocessing
  • devices with enough evidence to support reprocessing
  • devices that need more research
• Recommends programs or activities to support reprocessing, including third-party reprocessors, cleaning and sterilization technology, tracking and quality systems, and infection controls

Bottom line

The bill does not directly change the rules for reprocessing single-use devices. Instead, it orders a federal study and report that could lead to future policy changes if the study finds more devices can be reused safely and effectively.

Relevant Companies

None found