Current through Register Vol. 35, No. 18, September 24, 2024
Medical therapeutic or cosmetic devices penetrate and alter
human tissue and can result in complications such as visual impairment,
blindness, inflammation, burns, scarring, hypo-pigmentation and
hyper-pigmentation. The use of medical therapeutic and cosmetic devices is the
practice of medicine as defined in Section
61-6-1 NMSA
1978.
A. Limitations.
(1) Medical assistants are limited to using
medical therapeutic and cosmetic devices that are non-incisive and
non-ablative.
(2) Medical
therapeutic and cosmetic devices may only be used by a medical assistant who is
certified pursuant to Subsection D of 16.10.13.7 NMAC and when the supervising
physician is immediately available on the premises.
B. Responsibility of the supervising
physician. A physician who is trained in the safety and use of medical
therapeutic or cosmetic devices may supervise medical assistants who perform
hair removal and other therapeutic or cosmetic procedures using devices that
use waveform energy consistent with the following requirements.
(1) The supervising physician must provide
the following services before treatment by a medical assistant is initiated:
patient history, physical examination, diagnosis, treatment protocol, and
preparation of medical record.
(2)
The supervising physician shall review any adverse outcomes or changes in the
treatment protocol.
(3) The
supervising physician shall assure the patient is informed and aware that the
individual performing the procedure is a medical assistant and is under the
physician's supervision.
(4) The
supervising physician shall provide the patient instructions for emergency and
follow-up care.
(5) The supervising
physician shall prepare a written protocol for the medical assistant to follow
when using the medical therapeutic or cosmetic device. The protocol may include
pre and post care treatment related to the procedure as long as the treatment
is topical and non-injectable. The physician is responsible for ensuring that
the medical assistant uses the medical therapeutic or cosmetic device only in
accordance with the written protocol and does not exercise independent medical
judgment when using the device.
(6)
The supervising physician shall assure compliance with the training and
reporting requirements of this rule.
(7) The supervising physician is ultimately
responsible for the safety of the patient, regardless of who performs the
treatment using the medical therapeutic or cosmetic device or
procedure.
C. Training
requirements. Medical assistants who use medical therapeutic or cosmetic
devices must have training and be certified on each device they will use. The
training on each device must include the following:
(1) physics and safety of the medical
therapeutic or cosmetic device;
(2)
basic principle of the planned procedure;
(3) clinical application of the medical
therapeutic or cosmetic device, including wavelengths to be used;
(4) indications and contraindications for the
use of the medical therapeutic or cosmetic device;
(5) pre-operative and post-operative
care;
(6) recognition and acute
management of complications that may result from the procedure; and
(7) infectious disease control procedures
required for each procedure.
D. Reporting requirements. The supervising
physician shall complete a "certificate of training" form and submit it to the
board prior to the use of a medical therapeutic or cosmetic device by the
medical assistant. The form will be device-specific and document training for
each medical therapeutic or cosmetic device used by the medical
assistant.
E. Public communication.
Any public communication offering the performance or administration of a
cosmetic medical procedure or treatment shall identify the physician or surgeon
responsible for the provision of, or the direct supervision of the procedure or
treatment.
