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| [ Introduced ] | [ Enrolled ] | [ House Amendment 001 ] |
| [ Senate Amendment 001 ] |
90_SB0080eng
410 ILCS 620/16.5 new
Amends the Illinois Food, Drug and Cosmetic Act to
prohibit the repeated use of surgical devices designed for
single use.
LRB9001178DPcc
SB80 Engrossed LRB9001178DPcc
1 AN ACT to amend the Illinois Food, Drug and Cosmetic Act
2 by adding 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 adding Section 16.5 as follows:
7 (410 ILCS 620/16.5 new)
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 reuse, recycling, and refurbishing of single-use surgical
17 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. A person convicted of violating this
29 subsection is guilty of a business offense and shall be fined
30 not less than $1,000 for the first violation and not less
31 than $2,000 for a second or subsequent violation.