Second Substitute S.B. 110

Senator D. Chris Buttars proposes the following substitute bill:

1 MEDICAL DEVICE NOTIFICATION AND
2 LIABILITY
3 2005 GENERAL SESSION
4 STATE OF UTAH
5 Sponsor: D. Chris Buttars
6
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
24
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.