Liability of reprocessor of single-use medical devices.
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(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.