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House passes bill shifting liability for reprocessed single‑use medical devices to reprocessors
Summary
The Utah House approved Second Substitute Senate Bill 110, assigning liability for devices labeled single‑use to the entity that reprocesses them; supporters said it protects original manufacturers, while opponents warned about patient safety and questioned the availability of failure‑rate data for second uses.
The Utah House on March 1 passed Second Substitute Senate Bill 110, a measure that places legal responsibility for reprocessed single‑use medical devices on the reprocessor rather than on the original manufacturer. The bill passed on third reading by a recorded vote of 64 to 7 and will be sent back to the Senate.
Sponsor explanation and aim
Sponsor Representative Urquhart said Utah has "a thriving medical device industry" and that the bill addresses devices that manufacturers test and label for single use. "If you reprocess a device that was intended for single use then you've assumed all the liability for that product," Urquhart said, explaining the bill's purpose is to limit multi‑party lawsuits and to make clear who is responsible for a device used a second time.
Why supporters favored the change
Supporters argued the measure protects Utah manufacturers from lawsuits stemming from uses the manufacturer never intended. "If somebody else wants to do something else with it, then they have to accept responsibility," Representative Hoag said in floor remarks supporting the bill.
Key questions from the floor
Opponents and questioners pressed the sponsor on scope and safety. Representative Ray asked why the medical facility that contracts reprocessing services would not share liability; Urquhart replied the bill targets the entity that performs the reprocessing and assumes the liability when it resells the device. Representative Clark asked whether a reprocessor who takes physical possession and profits from resale could nonetheless be left without liability under current law; the sponsor replied existing practice often pulls multiple parties into litigation and the bill seeks to clarify that liability rests with the reprocessor.
Federal context and data gaps
The sponsor said the bill closely parallels Food and Drug Administration language and guidance on reprocessing and cited an FDA identification of roughly 228 device types known to be reprocessed. He also said he was "not aware" of reliable statistics comparing failure rates on second use versus initial use.
Next steps
After a motion to end debate, summation was waived and the House voted. With the passage, the bill is referred to the Senate for further action. The transcript records the sponsor framing the law as harmonizing state liability rules with federal reprocessing categories and members requesting additional data on safety outcomes for reprocessed devices.
