I am frequently asked to comment on the distinction between
what is medical and what is aesthetic (non-medical)....the lines are blurry but
in my opinion, they are being violated on a daily basis. The practice of
medicine is relatively easy to define....it is the diagnosis OR treatment of a
medical condition. Good, bad or
indifferent, acne, rosacea, eczema are medical conditions. Some things may not
be as clear...for example, treating "razor bumps" MAY not be medical,
but on the other hand, those "razor bumps" are follicultis barbae and
then they would be medical. Frustrating...I know.
Additionally, the next level of analysis would be whether
any medical device or product is being utilized in the treatment and of so,
what federal classification is the device. Virtually all aesthetic lasers AND
IPLs are Class II or Class IIb medical devices and they have to be owned and
operated by licensed physicians (not RNs). Physicians may, in certain
circumstances, delegate "operation" (but not ownership) to other
individuals.
Many products are medical...Botox Cosmetic is a prescription
drug...100% medical. The dermal fillers (Restylane for example) are all medical PRODUCTS (not a drug).
They are still 100% medical but for a different reason.
In laser, you can look at two different types of
scenarios...let's use laser hair removal and the treatment of leg veins. Laser hair removal is NOT a medical
procedure. However, if the patient is hirsute because of poly cystic ovary
syndrome (PCOS), then it IS medical. In
this situation the treatment may not be medical but the device IS medical.
Hence, laser hair removal IS medical.
Treatment of leg veins...this is both a medical treatment
and a medical device. Two reasons not to perform this service.
With peels, it gets REALLY complex...one analysis would be
to look at FDA guidelines. In 1996 the FDA concluded that "medical"
is a product that penetrated the epi-dermal/dermal junction. They concluded
that a 30% glycolic treatment achieves this. Prior to 1996, they mandated that
a 40% glycolic solution achieved this. But what 30% glycolic? pure 30%,
neutralized or buffered 30%?...remain unanswered. Soooo, if you utilize a 40%
glycolic solution but you know that it is neutralized or buffered, then you are
probably OK.
Jessner's peels and most TCA peels are mid-to high level
strength peels and they are medical. Sal acid is non medical unless in high
strengths....hydro quinones are non medical if they are under 2%...we could go
on for hours...topical anesthetics can be medical or non medical
too...depending upon the strength and formulation (this is actually a HUGE
issue)
The problem is that regulation comes in the form of....state
statutes, state and federal case law, federal mandate (FDA, FTC), state boards
of medicine, cosmetology and nursing, Attorney General reports and
cases...WHEW. There is no ONE place to look!
Recently, there was a discussion and an esthetician
commented to me that she contacted her state board in NH. They said that as
long as she was certified, it was OK for her to perform the procedure (I do not
recall the specific procedure, but on its face, it was medical ...blade or
syringe was utilized if I recall). That may have been true by NH board
purposes, but federal law would disagree and Federal law trumps state law.
Paddy Deighan J.D. Ph.D
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