Utah § 78B-4-505 Liability of reprocessor of single-use medical devices.

Utah Statutes

§ 78B-4-505 — Liability of reprocessor of single-use medical devices.

Utah § 78B-4-505

Title 78BJudicial Code

Ch. 78B-4Limitations on Liability

Part 78B-4-5Particular Limitations on Liability

This text of Utah § 78B-4-505 (Liability of reprocessor of single-use medical devices.) is published on Counsel Stack Legal Research, covering Utah primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Utah Code Ann. § 78B-4-505 (2026).

Text

(1)For purposes of this section:

(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

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(1) For purposes of this section:

(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.