Public Act 90-0398 of the 90th General Assembly
Public Act 90-0398
SB80 Enrolled LRB9001178DPcc
AN ACT to amend the Illinois Food, Drug and Cosmetic Act
by adding Section 16.5.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Illinois Food, Drug and Cosmetic Act is
amended by adding Section 16.5 as follows:
(410 ILCS 620/16.5 new)
Sec. 16.5. Single-use surgical devices.
(a) The General Assembly finds that certain surgical
devices are designed to be used for only one surgical
procedure. Further, the reuse, recycling, and refurbishing of
surgical devices intended for single use have been linked to
cases of patient infection, chemical injury, and mechanical
failure. It is therefore the purpose of this Section to
protect the public health and safety by prohibiting the
unregulated reuse, recycling, and refurbishing of single-use
surgical devices.
(b) For purposes of this Section, "single-use surgical
device" means a cardiac catheter, angioplasty balloon
catheter, arthroscopic knee surgery blade, and any other
device marketed or sold as a disposable or single-use device
as determined by rule of the Department of Public Health to
be designed for use in a single surgical procedure to avoid
risk of infection from improper sterilization or risk of
mechanical failure posed by subsequent use.
(c) No person shall knowingly reuse, recycle or
refurbish for reuse, or provide for reuse of a single-use
surgical device. However, this Section does not apply to
persons who utilize, recycle or reprocess for utilization, or
provide for utilization a single-use surgical device that has
been reprocessed by an entity or person registered with and
regulated by the United States Food and Drug Administration
or reprocessed by a hospital licensed under the Hospital
Licensing Act or the University of Illinois Hospital Act. A
person convicted of violating this subsection is guilty of a
business offense and shall be fined not less than $1,000 for
the first violation and not less than $2,000 for a second or
subsequent violation.