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91_SB1217
LRB9100611DJcdA
1 AN ACT to amend the Illinois Food, Drug and Cosmetic Act
2 by changing Section 16.5.
3 Be it enacted by the People of the State of Illinois,
4 represented in the General Assembly:
5 Section 5. The Illinois Food, Drug and Cosmetic Act is
6 amended by changing Section 16.5 as follows:
7 (410 ILCS 620/16.5)
8 Sec. 16.5. Single-use surgical devices.
9 (a) The General Assembly finds that certain surgical
10 devices are designed to be used for only one surgical
11 procedure. Further, the reuse, recycling, and refurbishing of
12 surgical devices intended for single use have been linked to
13 cases of patient infection, chemical injury, and mechanical
14 failure. It is therefore the purpose of this Section to
15 protect the public health and safety by prohibiting the
16 unregulated reuse, recycling, and refurbishing of single-use
17 surgical devices.
18 (b) For purposes of this Section, "single-use surgical
19 device" means a cardiac catheter, angioplasty balloon
20 catheter, arthroscopic knee surgery blade, and any other
21 device marketed or sold as a disposable or single-use device
22 as determined by rule of the Department of Public Health to
23 be designed for use in a single surgical procedure to avoid
24 risk of infection from improper sterilization or risk of
25 mechanical failure posed by subsequent use.
26 (c) No person shall knowingly reuse, recycle or
27 refurbish for reuse, or provide for reuse of a single-use
28 surgical device. However, this Section does not apply to
29 persons who utilize, recycle or reprocess for utilization, or
30 provide for utilization a single-use surgical device that has
31 been reprocessed by an entity or person registered with and
-2- LRB9100611DJcdA
1 regulated by the United States Food and Drug Administration
2 or reprocessed by a hospital licensed under the Hospital
3 Licensing Act or the University of Illinois Hospital Act. A
4 person convicted of violating this subsection is guilty of a
5 business offense and shall be fined not less than $1,000 for
6 the first violation and not less than $2,000 for a second or
7 subsequent violation.
8 (Source: P.A. 90-398, eff. 1-1-98.)
9 Section 99. Effective date. This Act takes effect upon
10 becoming law.