78B-4-505 - Liability of reprocessor of single-use medical devices.
78B-4-505. Liability of reprocessor of single-use medical devices.
(1) For purposes of this section:
(a) "Critical single-use medical device" means a medical device that:
(i) is marked as a single-use device by the original manufacturer; and
(ii) is intended to directly contact normally sterile tissue or body spaces during use, or isphysically connected to a device intended to contact normally sterile tissue or body spaces duringuse.
(b) "Original manufacturer" means any person or entity who designs, manufactures,fabricates, assembles, or processes a critical single-use medical device which is new and has notbeen used in a previous medical procedure.
(c) "Reprocessor" includes a person or entity who performs the functions of contractsterilization, installation, relabeling, remanufacturing, repacking, or specification development ofa reprocessed critical single-use medical device.
(d) "Reconditioned or reprocessed critical single-use medical device" means a criticalsingle use medical device that:
(i) has previously been used on a patient and has been subject to additional processingand manufacturing for the purpose of additional use on a different patient;
(ii) includes a device that meets the definition under Subsection (1)(a), but has beenlabeled by the reprocessor as "recycled," "refurbished," or "reused"; and
(iii) does not include a disposable or critical single-use medical device that has beenopened but not used on an individual.
(2) A reprocessor who reconditions or reprocesses a critical single-use medical deviceassumes the liability:
(a) of the original manufacturer of the critical single-use medical device; and
(b) for the safety and effectiveness of the reconditioned or reprocessed critical single-usemedical device.
Renumbered and Amended by Chapter 3, 2008 General Session