Friday, September 20, 2013

The Line Between Medical and Aesthetic Procedures: What Can an Esthetician do?

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 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 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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