2006 Utah Code - 78-11-28 — Liability of reprocessor of single-use medical devices.

     78-11-28.   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 is physically connected to a device intended to contact normally sterile tissue or body spaces during use.
     (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 not been used in a previous medical procedure.
     (c) "Reprocessor" includes a person or entity who performs the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development of a reprocessed critical single-use medical device.
     (d) "Reconditioned or reprocessed critical single-use medical device" means a critical single use medical device that:
     (i) has previously been used on a patient and has been subject to additional processing and 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 been labeled by the reprocessor as "recycled," "refurbished," or "reused"; and
     (iii) does not include a disposable or critical single-use medical device that has been opened but not used on an individual.
     (2) A reprocessor who reconditions or reprocesses a critical single-use medical device assumes 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-use medical device.

Enacted by Chapter 308, 2005 General Session