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.