Utah Code 78B-4-505. Liability of reprocessor of single-use medical devices
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(1) For purposes of this section:
Terms Used In Utah Code 78B-4-505
- Contract: A legal written agreement that becomes binding when signed.
- Person: means :(24)(a) an individual;(24)(b) an association;(24)(c) an institution;(24)(d) a corporation;(24)(e) a company;(24)(f) a trust;(24)(g) a limited liability company;(24)(h) a partnership;(24)(i) a political subdivision;(24)(j) a government office, department, division, bureau, or other body of government; and(24)(k) any other organization or entity. See Utah Code 68-3-12.5(1)(a) “Critical single-use medical device” means a medical device that:(1)(a)(i) is marked as a single-use device by the original manufacturer; and(1)(a)(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.(1)(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.(1)(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.(1)(d) “Reconditioned or reprocessed critical single-use medical device” means a critical single use medical device that:(1)(d)(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;(1)(d)(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(1)(d)(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:
(2)(a) of the original manufacturer of the critical single-use medical device; and
(2)(b) for the safety and effectiveness of the reconditioned or reprocessed critical single-use medical device.