April 30, 2009, Introduced by Senators HARDIMAN, JANSEN, ANDERSON, BIRKHOLZ and PAPPAGEORGE 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 or surgical treatment or care to patients.
(b) "Health professional" means an individual licensed,
certified, or authorized to engage in a health profession under
article 15, but not including dentists, dental hygienists, or
dental assistants under part 166.
(c) "Original device" means a new, unused single-use device.
(d) "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.
(e) "Single-use device" means a medical device that is
intended for 1 use or procedure, including any device marked
"single-use device".
(2) Except as otherwise provided in this section, a health
care provider shall not knowingly reuse, recycle, refurbish for
reuse, or provide for reuse a single-use device.
(3) This section does not apply to a health care provider that
utilizes, recycles or reprocesses for utilization, or provides for
utilization a single-use device that has been reprocessed by an
entity that is registered as a reprocessor and is regulated by the
United States food and drug administration.
(4) This section does not apply to a health care provider that
uses an opened, but unused single-use device that meets all of the
following requirements:
(a) The sterile packaging on the single-use device has been
opened and its sterility has been breached or compromised.
(b) The single-use device has not been used on a patient and
has not been in contact with blood or bodily fluids.
(c) The single-use device has been resterilized.
(5) 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.