State of Illinois
90^th General Assembly
Legislation

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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.

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