{"data":{"id":"us-ut/utah-code-78b-4-505","jurisdiction":"us-ut","citation":"Utah Code § 78B-4-505","heading":"Liability of reprocessor of single-use medical devices.","body":"(1) For purposes of this section:\n(a) \"Critical single-use medical device\" means a medical device that:\n(i) is marked as a single-use device by the original manufacturer; and\n(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.\n(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.\n(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.\n(d) \"Reconditioned or reprocessed critical single-use medical device\" means a critical single use medical device that:\n(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;\n(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\n(iii) does not include a disposable or critical single-use medical device that has been opened but not used on an individual.\n(2) A reprocessor who reconditions or reprocesses a critical single-use medical device assumes the liability:\n(a) of the original manufacturer of the critical single-use medical device; and\n(b) for the safety and effectiveness of the reconditioned or reprocessed critical single-use medical device.","path":["Title 78B Judicial Code","Chapter 78B-4 Limitations on Liability","Part 78B-4-5 Particular Limitations on Liability"],"source_url":"https://le.utah.gov/xcode/Title78B/Chapter4/78B-4-S505.html","current_through":"2026 General Session","vintage":"","retrieved_at":"2026-09-03T11:34:34Z","sha256":"7574042cfc135247e31e7ef86ffbb62d85bc7b06edcc5eb76cfccce810e4d46a","source_id":"us-ut","stale":false,"prev":"us-ut/utah-code-78b-4-504","next":"us-ut/utah-code-78b-4-506"},"notice":"GroundRules: Original legal text. Not legal advice."}