Section 5.08 - Safe Practice Provisions(1)In General. 243 CMR 5.08 contains the Committee's requirements for acupuncturists, acupuncture interns, and acupuncture assistants concerning the safe practice of acupuncture. The Committee may, at its discretion, issue additional requirements or guidelines that shall be observed by acupuncturists, interns and assistants.(2)Sterilization.(a) All nondisposable needles, acupuncture equipment that comes into contact with the patient's blood or body fluids, or penetrates the skin, and equipment used to handle or store needles or other acupuncture equipment that comes into contact with the patient's blood or body fluids, or penetrates the skin shall be sterilized after each use. All equipment to be sterilized shall be thoroughly cleaned before sterilization with a disinfectant or cleansing solution. Disposable needles do not need to be sterilized after each use but must be properly discarded after each use.(b) Sterilization equipment shall be used and maintained strictly in accordance with the guidelines of the manufacturer of the equipment. Use of one of the following methods of sterilization is required: 1. autoclaving with pressurized steam;2. dry heat sterilization; or3. ethylene oxide gas sterilization.(c) The following methods of sterilization are unacceptable: boiling acupuncture equipment, soaking acupuncture equipment in alcohol or other antiseptic solution, or using a glass bead sterilizer.(d) Sterilization equipment shall be monitored regularly in accordance with the manufacturer's guidelines to determine whether the equipment is functioning properly.(e) Sterilized acupuncture equipment shall be clearly marked to distinguish it from unsterilized equipment. Sealed packages containing sterilized equipment shall be marked with an expiration date. Any equipment that is not used on the day the equipment was removed from a sterilization package shall be resterilized before use.(f) All nondisposable needles shall be sterilized before disposal. After sterilization the needles shall be placed in a rigid, puncture-proof sealed container for disposal. Disposal containers shall be labeled as such, and shall carry the warning "CONTAMINATED CONTENTS--USE PRECAUTIONS." Disposal containers shall be wiped with a suitable disinfectant if blood or other bodily fluids are spilled on the outside. Disposal containers shall be discarded appropriately.(g) The parts of a patient's body to be treated shall be swabbed with alcohol or an antiseptic agent prior to needle insertion or any procedure which breaks the skin.(3)Use of Disposable Needles.(a) Before beginning the first treatment on a new patient, a licensee who normally uses nondisposable needles shall inform the patient that the patient has the right, if he/she so chooses and at his/her expense, to have acupuncture performed with disposable acupuncture needles.(b) If, in the course of treatment of a patient, a licensee learns that the patient has AIDS, hepatitis, or another blood-borne highly infectious disease, or has tested positive for the HTLV-III virus, then the licensee shall use disposable needles in treating the patient.(4)Use of Lasers. Within the practice of acupuncture, lasers and other regulated devices must be used in accordance with F.D.A. regulations and any other relevant laws and regulations. Investigational devices shall be used exclusively in a research setting and for research purposes.