Bill Text: IL HB1001 | 2023-2024 | 103rd General Assembly | Introduced

---

Bill Title: 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.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Failed) 2025-01-07 - Session Sine Die [HB1001 Detail]

Download: Illinois-2023-HB1001-Introduced.html

---

103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB1001 Introduced , 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
HB1001 LRB103 04880 CPF 49890 b
AN ACT concerning regulation.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the
Medical Device Safety Act.
Section 5. Definition. In this Act:
"Medical device" has the same meaning as defined in
Section 3 of the Pharmacy Practice Act.
Section 10. Medical device warranty; cost of replacement;
cost of follow-up surgeries.
(a) All medical devices to be used by, surgically applied
to, or surgically implanted within a patient in this State on
or after the effective date of this Act, regardless of whether
or not those medical devices are capable of being implanted,
must be under warranty, regardless of the severity of the
patient's medical condition necessitating the medical device.
(b) 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 in this
State on or after the effective date of this Act shall be
liable for all costs for the replacement of each medical
device to be used by, surgically applied to, or surgically

HB1001 - 2 - LRB103 04880 CPF 49890 b
implanted within a patient on or after the effective date of
this Act, regardless of whether or not that device is capable
of being implanted, if the device malfunctions due to no fault
of the patient.
(c) All hospitals licensed under the Hospital Licensing
Act or organized under the University of Illinois Hospital
Act, and all ambulatory surgical treatment centers licensed
under the Ambulatory Surgical Treatment Center Act, must 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.
Section 900. The University of Illinois Hospital Act is
amended by adding Section 8h as follows:
(110 ILCS 330/8h new)
Sec. 8h. Waiver of surgical costs. The University of
Illinois Hospital shall waive the costs charged to patients
for any follow-up surgery that results from a previous
surgical error that occurred at a University of Illinois
Hospital location.
Section 905. The Ambulatory Surgical Treatment Center Act
is amended by adding Section 10h as follows:

HB1001 - 3 - LRB103 04880 CPF 49890 b
(210 ILCS 5/10h new)
Sec. 10h. Waiver of surgical costs. An ambulatory surgical
treatment center shall waive the costs charged to patients for
any follow-up surgery that results from a previous surgical
error that occurred at that ambulatory surgical treatment
center.
Section 910. The Hospital Licensing Act is amended by
adding Section 11.9 as follows:
(210 ILCS 85/11.9 new)
Sec. 11.9. Waiver of surgical costs. A hospital shall
waive the costs charged to patients for any follow-up surgery
that results from a previous surgical error that occurred at
that hospital.
Section 999. Effective date. This Act takes effect upon
becoming law.