§ 333.20153

333.20153 Definitions; single-use device; reusing, recycling, or refurbishing prohibited; exceptions; violation as felony; penalty.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 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

ing 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.

ization, 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. History: Add. 2010, Act 25, Imd. Eff. Mar. 26, 2010 Popular Name: Act 368