78B-4-505. Liability of reprocessor of single-use medical devices.
(1) For purposes of this section: "Critical single-use medical device" means a medical device that: is marked as a single-use device by the original manufacturer; and 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. "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. "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. "Reconditioned or reprocessed critical single-use medical device" means a critical single use medical device that: 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; includes a device that meets the definition under Subsection, but has been labeled by the reprocessor as "recycled," "refurbished," or "reused"; and (1)(a) 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: of the original manufacturer of the critical single-use medical device; and for the safety and effectiveness of the reconditioned or reprocessed critical single-use medical device.