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S.B. 110 Enrolled

                 

MEDICAL DEVICE NOTIFICATION AND

                 
LIABILITY

                 
2005 GENERAL SESSION

                 
STATE OF UTAH

                 
Chief Sponsor: D. Chris Buttars

                 
House Sponsor: Stephen H. Urquhart

                  Curtis S. Bramble
                  Allen M. Christensen
                  Mike Dmitrich
                  Dan R. Eastman
                  Beverly Ann Evans
                  Parley G. HellewellJohn W. Hickman
Lyle W. Hillyard
Scott K. Jenkins
Sheldon L. Killpack
Peter C. Knudson
Mark B. MadsenL. Alma Mansell
Darin G. Peterson
Howard A. Stephenson
David L. Thomas
John L. Valentine
Carlene M. Walker                  
                  LONG TITLE
                  General Description:
                      This bill requires a reprocessor of a critical single-use medical device to assume the
                  liability associated with the original manufacturing and the reprocessing of the critical
                  single-use medical device.
                  Highlighted Provisions:
                      This bill:
                      .    amends the Judicial Code to establish that a reprocessor of a critical single-use
                  medical device assumes all liability related to the original manufacturing and
                  reprocessing of the critical single-use medical device.
                  Monies Appropriated in this Bill:
                      None
                  Other Special Clauses:
                      None
                  Utah Code Sections Affected:
                  ENACTS:
                      78-11-28, Utah Code Annotated 1953


                 
                  Be it enacted by the Legislature of the state of Utah:
                      Section 1. Section 78-11-28 is enacted to read:
                      78-11-28. Liability of reprocessor of single-use medical devices.
                      (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.


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