Download Zipped Introduced WordPerfect SB0110S02.ZIP
[Status][Bill Documents][Fiscal Note][Bills Directory]

Second Substitute S.B. 110

Senator D. Chris Buttars proposes the following substitute bill:





Sponsor: D. Chris Buttars

             7      LONG TITLE
             8      General Description:
             9          This bill requires a reprocessor of a critical single-use medical device to assume the
             10      liability associated with the original manufacturing and the reprocessing of the critical
             11      single-use medical device.
             12      Highlighted Provisions:
             13          This bill:
             14          .    amends the Judicial Code to establish that a reprocessor of a critical single-use
             15      medical device assumes all liability related to the original manufacturing and
             16      reprocessing of the critical single-use medical device.
             17      Monies Appropriated in this Bill:
             18          None
             19      Other Special Clauses:
             20          None
             21      Utah Code Sections Affected:
             22      ENACTS:
             23          78-11-28, Utah Code Annotated 1953
             25      Be it enacted by the Legislature of the state of Utah:

             26          Section 1. Section 78-11-28 is enacted to read:
             27          78-11-28. Liability of reprocessor of single-use medical devices.
             28          (1) For purposes of this section:
             29          (a) "Critical single use medical device" means a medical device that:
             30          (i) is marked as a "single-use" device by the original manufacturer; and
             31          (ii) is intended to directly contact normally sterile tissue or body spaces during use, or
             32      is physically connected to a device intended to contact normally sterile tissue or body spaces
             33      during use.
             34          (b) "Original manufacturer" means any person or entity who designs, manufactures,
             35      fabricates, assembles, or processes a critical single-use medical device which is new and has
             36      not been used in a previous medical procedure.
             37          (c) "Reprocessor" includes a person or entity who performs the functions of contract
             38      sterilization, installation, relabeling, remanufacturing, repacking, or specification development
             39      of a reprocessed critical single-use medical device.
             40          (d) "Reconditioned or reprocessed critical single-use medical device" means a critical
             41      single use medical device that:
             42          (i) has previously been used on a patient and has been subject to additional processing
             43      and manufacturing for the purpose of additional use on a different patient;
             44          (ii) includes a device that meets the definition under Subsection (1)(a), but has been
             45      labeled by the reprocessor as "recycled," "refurbished," or "reused"; and
             46          (iii) does not include a disposable or critical single-use medical device that has been
             47      opened but not used on an individual.
             48          (2) A reprocessor who reconditions or reprocesses a critical single-use medical device
             49      assumes the liability:
             50          (a) of the original manufacturer of the critical single use medical device; and
             51          (b) for the safety and effectiveness of the reconditioned or reprocessed critical
             52      single-use medical device.

[Bill Documents][Bills Directory]