Bill Text: MI HB4940 | 2009-2010 | 95th Legislature | Engrossed
Bill Title: Health; other; reuse of certain medical equipment and supplies; prohibit, and provide penalty. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding sec. 20153.
Spectrum: Moderate Partisan Bill (Democrat 13-2)
Status: (Introduced - Dead) 2009-06-16 - Referred To Committee On Health Policy [HB4940 Detail]
Download: Michigan-2009-HB4940-Engrossed.html
HB-4940, As Passed House, June 11, 2009
SUBSTITUTE FOR
HOUSE BILL NO. 4940
(As amended June 11, 2009)
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 [or veterinarians or veterinary
technicians under part 188].
(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
House Bill No. 4940 (H-2) as amended June 11, 2009
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.
(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
[does any of the following:
(a) 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.
[(b) Utilizes
] an opened, but unused single-use device for which the
sterility has been breached or compromised and that meets all of
the following requirements:
(a) The single-use device has not been used on a patient and
has not been in contact with blood or bodily fluids.
(b) The single-use device has been resterilized.
House Bill No. 4940 (H-2) as amended June 11, 2009
[(c) Utilizes a used single-use device on the same patient in an
emergency situation.
(4)] A health care provider that violates this section is
guilty of a felony punishable by imprisonment for not more than 10
years or a fine of not more than $50,000.00, or both. A violation
of this section by a health professional is considered a violation
of article 15 and that health professional is subject to
administrative action under sections 16221(h) and 16226.