[ Search ] [ Legislation ] [ Bill Summary ]
[ Home ] [ Back ] [ Bottom ]
|[ Introduced ]||[ Engrossed ]||[ House Amendment 001 ]|
|[ Senate Amendment 001 ]|
90_SB0080enr 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 Enrolled 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 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 SB80 Enrolled -2- LRB9001178DPcc 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.
[ Top ]