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.