Attorney's Note

Under the Michigan Laws, punishments for crimes depend on the classification. In the case of this section:
ClassPrisonFine
Dup to 10 years
For details, see Mich. Comp. Laws ch. 777 pt. 2

Terms Used In Michigan Laws 333.20153

  • Manufacturer: means a person that prepares, produces, derives, propagates, compounds, processes, packages, or repackages a drug or device salable on prescription only, or otherwise changes the container or the labeling of a drug or device salable on prescription only, and that supplies, distributes, sells, offers for sale, barters, or otherwise disposes of that drug or device and any other drug or device salable on prescription only, to another person for resale, compounding, or dispensing. See Michigan Laws 333.17706
  • person: may extend and be applied to bodies politic and corporate, as well as to individuals. See Michigan Laws 8.3l
  • United States: shall be construed to include the district and territories. See Michigan Laws 8.3o
  (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 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 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 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:
  (i) The single-use device has not been used on a human patient and has not been in contact with blood or bodily fluids.
  (ii) The single-use device has been resterilized.
  (c) Utilizes a used single-use device on the same human 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.