SB-0528, As Passed Senate, July 15, 2009

SUBSTITUTE FOR

SENATE BILL NO. 528

     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 human 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 human patient

and has been subjected to additional processing and manufacturing

for the purpose of additional use on a different human 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 on a human patient, 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 human 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. 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.