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.