(410 ILCS 620/16.5)
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.
(Source: P.A. 90-398, eff. 1-1-98.)
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