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91_SB1218
LRB9100611DJsbB
1 AN ACT to amend the Illinois Food, Drug and Cosmetic Act
2 by changing 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 changing Section 16.5 as follows:
7 (410 ILCS 620/16.5)
8 Sec. 16.5. Single-use surgical devices.
9 (a) Legislative findings. The General Assembly finds
10 that certain surgical devices are designed to be used for
11 only one surgical procedure. Further, the reuse, recycling,
12 and refurbishing of surgical devices intended for single use
13 have been linked to cases of patient infection, chemical
14 injury, and mechanical failure. It is therefore the purpose
15 of this Section to protect the public health and safety by
16 prohibiting the unregulated reuse, recycling, and
17 refurbishing of single-use surgical devices.
18 (b) Definitions. For purposes of this Section:,
19 "Department" means the Department of Public Health.
20 "End-of-life" means an established time-to-failure
21 period, determined by the original device manufacturer, based
22 upon reliability data and analysis to characterize a
23 non-repairable product.
24 "Manufacturer" means any person or entity who designs,
25 manufactures, fabricates, assembles, or processes a finished
26 device. "Manufacturer" includes, but is not limited to, those
27 who perform the functions of contract sterilization,
28 installation, relabeling, remanufacturing, repacking, or
29 specification development, and initial distributors of
30 foreign entities performing these functions.
31 "Recondition" or "rebuild" means to acquire ownership of
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1 used finished devices and restore or refurbish, or both
2 restore and refurbish, these to the device manufacturer's
3 original or current specifications, or new specifications,
4 for purposes of resale or commercial distribution.
5 "Refurbish" or "reprocess" means to process, condition,
6 renovate, or restore a finished device which has been
7 previously distributed and has reached its established
8 end-of-life or is considered to be non-repairable.
9 "Single-use surgical device" means a cardiac catheter,
10 angioplasty balloon catheter, arthroscopic knee surgery
11 blade, and any other device marketed or sold as a disposable
12 or single-use device, or labeled by its original manufacturer
13 or distributor as being intended or designed for use in a
14 single surgical procedure, as determined by rule of the
15 Department of Public Health to be designed for use in a
16 single surgical procedure to avoid risk of infection from
17 improper sterilization or risk of mechanical failure posed by
18 subsequent use.
19 "Substantial compliance" means meeting the requirements
20 set forth in this Section, except for variations from the
21 strict and literal performance of those requirements which
22 result in insignificant omissions and defects, given the
23 particular circumstances and the history of the omissions and
24 defects. Omissions and defects that have an adverse impact on
25 public health and safety shall not be considered
26 insignificant and shall be considered substantial
27 noncompliance.
28 (c) Prohibited actions. No person or entity shall
29 knowingly reuse, recycle, reprocess, or refurbish for reuse,
30 or provide for reuse of, a single-use surgical device, nor
31 shall any person or entity recondition or rebuild a
32 single-use surgical device, unless each of the following
33 conditions is met:
34 (1) If the person or entity doing the reuse,
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1 recycling, reprocessing, refurbishing for reuse, or
2 providing for the reuse of a single-use surgical device
3 is a hospital licensed under the Hospital Licensing Act
4 or the University of Illinois Hospital Act, and has
5 purchased the single-use surgical device for use within
6 the hospital, it shall do all of the following:
7 (A) Certify, if the hospital is itself
8 recycling, reprocessing, or refurbishing the
9 single-use surgical device, that it is in
10 substantial compliance with current good
11 manufacturing practices (CGMPs) for medical devices
12 under the United States Food and Drug
13 Administration's Quality System Regulation (21 CFR
14 820).
15 (B) Demonstrate, whether the single-use
16 surgical device is recycled, refurbished, or
17 reprocessed by the hospital itself or some other
18 entity on behalf of the hospital, that:
19 (i) the single-use surgical device is
20 capable of withstanding necessary cleaning and
21 resterilization techniques and methods;
22 (ii) the physical characteristics or
23 quality of the single-use surgical device will
24 not be adversely affected; and
25 (iii) the single-use surgical device
26 remains safe and effective for its intended
27 use.
28 (C) Ensure that its employees or other agents
29 who reuse, recycle, refurbish for reuse, reprocess,
30 or provide for reuse of a single-use surgical
31 device, whether recycled, reprocessed, or
32 refurbished by the hospital or another entity,
33 obtain, prior to treating any patient with a reused,
34 recycled, reprocessed, or refurbished single-use
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1 surgical device, a written, informed consent from
2 the patient, or, if the patient is not competent,
3 his or her legal guardian, stating that the patient:
4 (i) understands that he or she will be
5 treated with a reused, recycled, or refurbished
6 device that was originally designed, marketed,
7 and sold as a disposable or single-use device;
8 (ii) is aware of the potential risks
9 (such as infection from the device's use on a
10 previous patient, chemical injury from
11 incomplete sterilization processes, or
12 malfunction due to mechanical failure of the
13 device) and the potential benefit (lower cost
14 of the surgical procedure); and
15 (iii) does not object, and agrees to the
16 use of the reused, recycled, reprocessed, or
17 refurbished single-use surgical device.
18 (D) Bear full responsibility for the safety
19 and effectiveness of the reused, recycled,
20 reprocessed, or refurbished single-use surgical
21 device.
22 (E) File a report with the United States Food
23 and Drug Administration, as a manufacturer, in
24 compliance with 21 CFR 803, and forward a copy of
25 the report to the Department, whenever the hospital
26 becomes aware of information that suggests that a
27 single-use surgical device that was reused,
28 recycled, reprocessed, or refurbished by the
29 hospital, or another entity on behalf of the
30 hospital, may have:
31 (i) caused or contributed to a death or
32 serious injury; or
33 (ii) malfunctioned, and the single-use
34 surgical device or a similar device that would
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1 be reused, recycled, reprocessed, or
2 refurbished by the hospital, or another entity
3 on behalf of the hospital, would be likely to
4 cause a death or serious injury if the
5 malfunction were to recur.
6 (F) Ensure substantial compliance with this
7 Section, regardless of whether the hospital
8 contracts or subcontracts any of its obligations
9 under this Section, including every contractor's and
10 subcontractor's compliance with subdivision (c)(2).
11 (2) If the person or entity doing the reuse,
12 recycling, reprocessing, refurbishing for reuse, or
13 providing for the reuse of a single-use surgical device
14 is not a hospital licensed under the Hospital Licensing
15 Act or the University of Illinois Hospital Act, or if any
16 person or entity is reconditioning or rebuilding a
17 single-use surgical device, it shall do all of the
18 following:
19 (A) Register with the United States Food and
20 Drug Administration as set forth in section 510 of
21 the Federal Act and 21 CFR 807.20(a).
22 (B) Submit to the United States Food and Drug
23 Administration, for each type and brand of the
24 specific single-use surgical device it intends to
25 recycle, reprocess, refurbish, recondition, or
26 rebuild, either (i) a pre-market notification
27 ("510(k)") or (ii) a pre-market approval application
28 (PMA).
29 (C) Receive from the United States Food and
30 Drug Administration, prior to recycling,
31 reprocessing, refurbishing, reconditioning, or
32 rebuilding any single-use surgical device, either
33 (i) a determination of substantial equivalence for
34 each submitted pre-market notification ("510(k)") or
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1 (ii) an approval of each submitted pre-market
2 approval application (PMA). The person or entity
3 also shall provide a copy of the appropriate
4 documentation to the Department.
5 (D) Certify that it is in substantial
6 compliance with current good manufacturing practices
7 (CGMPs) for medical devices under the United States
8 Food and Drug Administration's Quality System
9 Regulation (21 CFR 820).
10 (E) File a report with the United States Food
11 and Drug Administration, as a manufacturer, in
12 compliance with 21 CFR 803, and forward a copy of
13 the report to the Department, whenever the person or
14 entity doing the reuse, recycling, reprocessing,
15 refurbishing for reuse, providing for the reuse of a
16 single-use surgical device, reconditioning, or
17 rebuilding a single-use surgical device becomes
18 aware of information that suggests that a single-use
19 surgical device that was reused, recycled,
20 reprocessed, refurbished, reconditioned, or rebuilt
21 by the person or entity may have:
22 (i) caused or contributed to a death or
23 serious injury; or
24 (ii) malfunctioned, and the single-use
25 surgical device or a similar device that would
26 be reused, recycled, reprocessed, or
27 refurbished by the hospital, or another entity
28 on behalf of the hospital, would be likely to
29 cause a death or serious injury if the
30 malfunction were to recur. However, this
31 Section does not apply to persons who utilize,
32 recycle or reprocess for utilization, or
33 provide for utilization a single-use surgical
34 device that has been reprocessed by an entity
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1 or person registered with and regulated by the
2 United States Food and Drug Administration or
3 reprocessed by a hospital licensed under the
4 Hospital Licensing Act or the University of
5 Illinois Hospital Act.
6 (d) Labeling. Any single-use surgical device that is
7 recycled, reprocessed, refurbished, reconditioned, or rebuilt
8 in accordance with this Section must be labeled with all of
9 the following:
10 (1) The name and address of the original
11 manufacturer of the device.
12 (2) All original labeling applied by the original
13 manufacturer of the device.
14 (3) The name and address of the hospital or other
15 entity conducting the recycling, reprocessing,
16 refurbishing, reconditioning, or rebuilding of the
17 single-use surgical device.
18 (4) The date of recycling, reprocessing,
19 refurbishing, reconditioning, or rebuilding of the
20 single-use surgical device.
21 (5) The number of times the specific single-use
22 surgical device has been recycled, reprocessed,
23 refurbished, reconditioned, or rebuilt.
24 (6) All labeling as specified by the United States
25 Food and Drug Administration in a cleared pre-market
26 submission.
27 (7) A statement indicating that the device has been
28 recycled, reprocessed, refurbished, reconditioned, or
29 rebuilt.
30 (e) Penalties.
31 (1) The reuse, recycling, reprocessing, or
32 refurbishing of a single-use surgical device in a manner
33 contrary to the requirements of this Section renders the
34 device adulterated within the meaning of Section 14 and
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1 misbranded within the meaning of Section 15.
2 (2) Failure to comply with the provisions of this
3 Section is prima facie evidence that the surgical device
4 is unreasonably dangerous and unfit for its intended use.
5
6 (3) A person or entity convicted of violating this
7 subsection is guilty of a business offense and shall be
8 fined not less than $1,000 for the first violation and
9 not less than $2,000 for a second or subsequent
10 violation.
11 (f) Hearings. If any fine is imposed pursuant to
12 subdivision (e)(3), the person or entity against whom the
13 fine is imposed may request a hearing in accordance with this
14 Act and the Department's rules.
15 (Source: P.A. 90-398, eff. 1-1-98.)
16 Section 99. Effective date. This Act takes effect upon
17 becoming law.