Public Act 90-0398 of the 90th General Assembly

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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.

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