State of Illinois
90th General Assembly
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[ Introduced ][ Enrolled ][ House Amendment 001 ]
[ Senate Amendment 001 ]

90_SB0080eng

      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 Engrossed                                 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    reuse,  recycling,  and  refurbishing  of single-use surgical
17    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.  A  person  convicted  of  violating   this
29    subsection is guilty of a business offense and shall be fined
30    not  less  than  $1,000  for the first violation and not less
31    than $2,000 for a second or subsequent violation.

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