SENATE BILL No. 1442

 

 

July 17, 2008, Introduced by Senators HARDIMAN, PAPPAGEORGE, BIRKHOLZ, JACOBS and JANSEN and referred to the Committee on Health Policy.

 

 

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

(MCL 333.1101 to 333.25211) by adding section 20153.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 20153. (1) As used in this section:

 

     (a) "Health care provider" means a health facility or agency

 

or a health professional that utilizes single-use devices in

 

furnishing medical, surgical, or dental treatment or care to

 

patients.

 

     (b) "Health professional" means an individual licensed,

 

certified, or authorized to engage in a health profession under

 

article 15.

 

     (c) "Original device" means a new, unused single-use device.

 


     (d) "Original manufacturer" means any person who designs,

 

manufactures, fabricates, assembles, or processes a finished

 

medical device that is new and has not been used in a previous

 

medical procedure.

 

     (e) "Reprocessed" means with respect to a single-use device,

 

an original device that has previously been used on a patient and

 

has been subjected to additional processing and manufacturing for

 

the purpose of additional use on a different patient. Reprocessed

 

includes the subsequent processing and manufacture of a reprocessed

 

single-use device and any single-use device that meets the

 

definition in this subdivision without regard to any description of

 

the device used by the manufacturer of the device or other persons,

 

including a description that uses the term "recycled",

 

"refurbished", or "reused" rather than the term "reprocessed".

 

Reprocessed does not include a disposable or single-use device that

 

has been opened but not used on a person.

 

     (f) "Reprocessor" includes, but is not limited to, a person

 

who performs the functions of contract sterilization installation,

 

relabeling, remanufacturing, repacking, or specification

 

development of reprocessed single-use devices.

 

     (g) "Single-use device" means a medical device that is

 

intended for 1 use on a single patient during a single procedure,

 

including any device marked "single-use device".

 

     (2) Except as otherwise provided in this section, a health

 

care provider shall not use a reprocessed single-use device on a

 

patient. A health care provider may use a reprocessed single-use

 

device on a patient if the health care provider obtains the

 


patient's signed, written consent as required under this section.

 

If obtained under this section, the health care provider shall

 

include the signed, written consent in the permanent medical record

 

of the patient.

 

     (3) Except as otherwise provided in this section, a health

 

care provider shall provide to each patient on admission or

 

registration a written notice that describes all of the following:

 

     (a) The practices of the health care provider regarding

 

reprocessed single-use devices, including the circumstances under

 

which reprocessed single-use devices are used, and the safeguards

 

taken by the health care provider to ensure the safety of the

 

patient under those circumstances.

 

     (b) The potential risks of using reprocessed single-use

 

devices generally and in the specific application with regard to

 

that patient.

 

     (4) The written notice required in subsection (3) shall

 

provide the patient an opportunity to consent or refuse consent to

 

the use of reprocessed single-use devices on the patient. The

 

health care provider shall not use the patient's refusal to consent

 

to the use of reprocessed single-use devices to in any way limit

 

the patient's access to health care, including the use of an

 

original device. The written notice required in subsection (3)

 

shall meet all of the following requirements:

 

     (a) Be separate from all other documents provided to the

 

patient.

 

     (b) Be in plain language.

 

     (c) Provide a place to indicate the patient's consent or

 


refusal to consent.

 

     (d) Provide a signature line for the patient.

 

     (e) Be approved by the department.

 

     (5) A health care provider shall submit a written notice

 

required in subsection (3) to the department for approval before

 

use under this section. The department shall approve a written

 

notice submitted to it under this subsection if it meets the

 

requirements of subsections (3) and (4), including the adequacy of

 

the notice itself and the adequacy of the description of potential

 

risks provided in the notice.

 

     (6) Except as otherwise provided in this section, on admission

 

or registration of a patient, a health care provider shall require

 

the attending physician or the attending physician's designee to do

 

all of the following:

 

     (a) Describe verbally the contents of the written notice

 

required in subsection (3) to the patient, including the patient's

 

opportunity to consent or refuse consent to the use of reprocessed

 

single-use devices.

 

     (b) Ensure that the patient understands the contents of the

 

written notice required in subsection (3).

 

     (c) If necessary, arrange for an interpreter to facilitate the

 

patient's comprehension of the written notice required in

 

subsection (3).

 

     (7) If a health care provider has admitted or registered a

 

patient in compliance with this section, the health care provider

 

is not required to comply with this section during subsequent

 

admissions or registrations of the same patient if the health care

 


provider verifies that the patient's provision or refusal of

 

consent to the use of reprocessed single-use devices is recorded in

 

the permanent medical record of the patient and unless the patient

 

revokes consent in a subsequent written document provided to the

 

health care provider. A health care provider shall comply with a

 

patient's written revocation, which is effective regardless of its

 

form.

 

     (8) A reprocessor is liable for the safety and effectiveness

 

of any reprocessed single-use device. A health care provider who

 

fails to fulfill the informed patient consent requirement in this

 

section is also liable. An original manufacturer is not liable for

 

the use, safety, or effectiveness of a reprocessed single-use

 

device unless the original manufacturer has expressly and

 

specifically consented to the use of the reprocessed device in that

 

specific instance.

 

     (9) A person shall promptly notify the department if the

 

person performing the reuse, recycling, reprocessing, or

 

refurbishing for reuse, or providing for the reuse of a single-use

 

device or the reconditioning or rebuilding of a single-use device,

 

becomes aware of information that suggests that a single-use device

 

that was reused, recycled, reprocessed, refurbished, reconditioned,

 

or rebuilt by a person or entity may meet any of the following:

 

     (a) Caused or contributed to a death or serious injury.

 

     (b) Malfunctioned.

 

     (c) The single-use device, or a similar device, that would be

 

reused, recycled, reprocessed, or refurbished by a health facility

 

or agency or other entity on behalf of the health facility or

 


agency, would be likely to cause a death or serious injury if a

 

malfunction were to occur.

 

     (10) Failure of a reprocessor or health care provider to

 

comply with this section is prima facie evidence that the

 

reprocessing of the device alone has rendered a reprocessed single-

 

use device unreasonably dangerous and unfit for its intended use.

 

     (11) A person who violates this section is subject to a fine

 

of not less than $10,000.00 for the first offense and not less than

 

$20,000.00 for the second and subsequent offenses. Remedies

 

provided under this section are not exclusive of any other remedies

 

that may be pursued against a reprocessor or health care provider.