HB1001 103RD GENERAL ASSEMBLY

LRB103 04880 CPF 49890 b

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.

A BILL FOR

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 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:

(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.