103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB1001

 

Introduced 1/12/2023, by Rep. Mary E. Flowers

 

SYNOPSIS AS INTRODUCED:
 
New Act
110 ILCS 330/8h new
210 ILCS 5/10h new
210 ILCS 85/11.9 new

    Creates the Medical Device Safety Act. Provides that (i) all medical devices to be used by, surgically applied to, or surgically implanted within a patient be under warranty, regardless of the severity of the patient's medical condition necessitating the device, (ii) all persons and entities that produce, sell, offer for sale, or provide medical devices to be used by, surgically applied to, or surgically implanted within a patient are liable for all costs to the patient for the replacement of each medical device if the medical device malfunctions due to no fault of the patient, and (iii) all hospitals and ambulatory surgical treatment centers shall waive the costs charged to patients for follow-up surgeries that result from defective medical devices, regardless of whether or not those defective medical devices are capable of being implanted. Amends the University of Illinois Hospital Act, the Ambulatory Surgical Treatment Center Act, and the Hospital Licensing Act. Requires that the University of Illinois Hospital, all ambulatory surgical treatment centers, and all hospitals licensed under the Hospital Licensing Act waive the costs charged to patients for follow-up surgeries that result from previous surgical errors. Effective immediately.


LRB103 04880 CPF 49890 b

 

 

A BILL FOR

 

HB1001LRB103 04880 CPF 49890 b

1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Medical Device Safety Act.
 
6    Section 5. Definition. In this Act:
7    "Medical device" has the same meaning as defined in
8Section 3 of the Pharmacy Practice Act.
 
9    Section 10. Medical device warranty; cost of replacement;
10cost of follow-up surgeries.
11    (a) All medical devices to be used by, surgically applied
12to, or surgically implanted within a patient in this State on
13or after the effective date of this Act, regardless of whether
14or not those medical devices are capable of being implanted,
15must be under warranty, regardless of the severity of the
16patient's medical condition necessitating the medical device.
17    (b) All persons and entities that produce, sell, offer for
18sale, or provide medical devices to be used by, surgically
19applied to, or surgically implanted within a patient in this
20State on or after the effective date of this Act shall be
21liable for all costs for the replacement of each medical
22device to be used by, surgically applied to, or surgically

 

 

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1implanted within a patient on or after the effective date of
2this Act, regardless of whether or not that device is capable
3of being implanted, if the device malfunctions due to no fault
4of the patient.
5    (c) All hospitals licensed under the Hospital Licensing
6Act or organized under the University of Illinois Hospital
7Act, and all ambulatory surgical treatment centers licensed
8under the Ambulatory Surgical Treatment Center Act, must waive
9the costs charged to patients for follow-up surgeries that
10result from defective medical devices, regardless of whether
11or not those defective medical devices are capable of being
12implanted.
 
13    Section 900. The University of Illinois Hospital Act is
14amended by adding Section 8h as follows:
 
15    (110 ILCS 330/8h new)
16    Sec. 8h. Waiver of surgical costs. The University of
17Illinois Hospital shall waive the costs charged to patients
18for any follow-up surgery that results from a previous
19surgical error that occurred at a University of Illinois
20Hospital location.
 
21    Section 905. The Ambulatory Surgical Treatment Center Act
22is amended by adding Section 10h as follows:
 

 

 

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1    (210 ILCS 5/10h new)
2    Sec. 10h. Waiver of surgical costs. An ambulatory surgical
3treatment center shall waive the costs charged to patients for
4any follow-up surgery that results from a previous surgical
5error that occurred at that ambulatory surgical treatment
6center.
 
7    Section 910. The Hospital Licensing Act is amended by
8adding Section 11.9 as follows:
 
9    (210 ILCS 85/11.9 new)
10    Sec. 11.9. Waiver of surgical costs. A hospital shall
11waive the costs charged to patients for any follow-up surgery
12that results from a previous surgical error that occurred at
13that hospital.
 
14    Section 999. Effective date. This Act takes effect upon
15becoming law.