{"data":{"id":"us-mi/mich.-comp.-laws-333.20153","jurisdiction":"us-mi","citation":"Mich. Comp. Laws § 333.20153","heading":"Definitions; single-use device; reusing, recycling, or refurbishing prohibited; exceptions; violation as felony; penalty.","body":"Sec. 20153.\n\n(1) As used in this section:\n\n(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.\n\n(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.\n\n(c) \"Original device\" means a new, unused single-use device.\n\n(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.\n\n(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\".\n\n(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.\n\n(3) This section does not apply to a health care provider that does any of the following:\n\n(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.\n\n(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:\n\n( i ) The single-use device has not been used on a human patient and has not been in contact with blood or bodily fluids.\n\n( ii ) The single-use device has been resterilized.\n\n(c) Utilizes a used single-use device on the same human patient in an emergency situation.\n\n(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.","path":["MI Code","Chapter 333","Act Act-368-of-1978"],"source_url":"https://www.legislature.mi.gov/Laws/MCL?objectName=mcl-333-20153","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:31Z","sha256":"c05e00cb070212e1001466b99931f3619f50effac7abadb5745f78410a87dd59","source_id":"us-mi","stale":false,"prev":"us-mi/mich.-comp.-laws-333.20152","next":"us-mi/mich.-comp.-laws-333.20155"},"notice":"GroundRules: Original legal text. Not legal advice."}