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« Plastic Surgery & Malpractice Lawsuits In The US & Canada | Main | Bad Reviews Of Your Medical Spa? Yelp Accused Of Extortion »
Wednesday
Dec122012

Medical Devices & Estheticians

It's true, medical devices are used by Estheticians.

In most clinics in the US, esteticians are often used to perform treatments... but outside the US not so much. Here's an email I received from Susanne Warfield, Executive Director of NCEA, taking us to task for 'misinformation'.

Susanne Warfield - Executive Director NCEA

I received a call from one of our members regarding your website and the statement about estheticians using medical devices.

Estheticians are using medical devices every day...- even an electric tooth brush is a medical device as defined by the FDA. It is very important that we understand that any device sold and marketed in the United States must be registered with the FDA and laser and light therapy devices are just another medical device that have "Indications for Use" and "Intended Use".


Please update your misinformation on your website as it it incorrect. Thank you

Anyone have thoughts on what an esthetician in the US (or each state) can or can not perform? Where's the line?

Reader Comments (9)

I always despise when this question arises because a berrage of insults and nasty comments always follows. Having said that here I go. It is ridiculous to comapre a toothbrush to a class IV medical laser. THe FDA is not concerned about who uses the laser the FDA wants to ensure that the system accomplishes its intended function and does so similarly to exhisting units and performs to a uniform standard thus every use ( say emittion is of uniform diameter, frequency and power). If someone not qualified to use the laser is doing so it is not the FDA that gets involved but the licnesing board of each state and the office of professional discipline.

I always find it humerous whe persons with little or zero medical education seem to feel the term medical when placed before the word laser, instrument or chemical peel is just there for effect. It should be intuitave that when MEDICAL is used you should be a medical provider.

The real problem is in the variability between state laws. NJ is straight forward only medical doctors fire lasers peroid. NY is a bit more liberal they deemed as of 2010 that lasers non ablaitive, as well as ablaitive are medical devices and are to be used by medical professionals anyone else is practicing out of the scope of the license.

Decision Regarding Laser Devices/ Appearance Enhancement Licensees
ALBANY, N.Y. (January 28, 2010) -- The Department issued a decision regarding the use of laser devices by appearance enhancement licensees. This decision held that laser and non-ablative radio-frequency procedures, including Thermage, are the practice of medicine and beyond the scope of practice for appearance enhancement licensees

Now the real problem in NY is enforcement. The OPD is deluged with complaints so it takes an average of 4-6 months to really get a good investigation going. They also do not scour the media for spas practicing medicine, they go by complaints only. I was told this personally by a lawyer in the field. That allows for may spas to go under the radar for long periods of time.
. I have been a physician almost 30 years and have seen my profession degrade year after year. I also do alot of malpractice review and yes MD's error but the reality is most of the time burns scars infections are secondary to persons with no medical training performing procedures that are above their capability and ending up with complications they can not nor know how to handle.

So what happens. Well the medical director tries to back out but most of the time cant and gets hit for the occurance and the estetician gets repremanded and possibly can lose their license if this occurs again. Often the patient is stuck in the middle if there is no medical director and the spa lacks insurance.

So ther is the NYS law, I didnt pull it out of a hat it came directly from the beueau of prof licensure NYS.
Thus in NY esteticians cant use lasers

12.13 | Unregistered Commentergm

I concur with the response of "gm" to Susanne Warfield's preposterous statement about aestheticians "using medical devices every day...- even an electric tooth brush is a medical device as defined by the FDA", etc.. Ms. Warfield is correct in stating that "any device sold and marketed in the United States must be registered with the FDA" but her statement that lasers, light therapy, ultrasound, and RF devices are just medical devices that have "Indications for Use" and "Intended Uses" omits the important fact that these devices can only be purchased and/or used in the US by or under the supervision of a licensed health care practitioner (in most cases a physician). I have been reading and contributing to this web site for the past six years and I can assure you that literally hundreds of comments have been submitted about the pertinent state and federal regulations. Some of the comments have been correct and many have been incorrect. I can assure you that these issues are complex and in order to protect yourself you would be wise to get the advice of an experienced attorney in your state to help you navigate these complex waters before taking the risk of being brought before your state medical or nursing board for one infraction or another. The fact that "everyone else is doing it" will not protect you if you are investigated...

I think that NY is the most restrictive in scope of practice with IPLs and cosmetic lasers. I know of many states that have been pretty lax. My own feeling is that the supervising physician should be required to see every patient and sign off on the treatment area but not be required to push the button.

Ms. Warfield is wrong on two counts, but her concern is merited. She is wrong in stating that an electronic toothbrush is a medical device. It's not. It's an electronic toothbrush. A toothbrush is not a medical device any more than a bar of soap, a comb, or a tampon is. These are devices intended for hygiene, though oral hygiene is a medical necessity.

She is also wrong to say that any device sold in the US has to be registered with the FDA. Simply not true. Many devices don't require FDA approval. You can purchase the same type of electronic temporal thermometer at Walgreens that they use in the ER. The one in the ER requires "some" FDA approval, but not 510K or PMA. The one at Walgreens only needs a label that says "not for hospital use" or something similar.

As far as who should be using medical devices there must be a clear distinction between opinion, Federal laws and regulations, recommendations from private organizations like ASLMS, and State and Local laws. As far as opinion goes, the most common sense response is that anybody not trained medically should not use any device that can harm a patient.

Federal laws and regulations only seem to specify surgical vs. non-surgical use. Only a physician may perform ablative treatments, for example, or treatments outside of the intended use. For example, Yag lasers are being used for onychomicosis. Note that NO laser is FDA approved for the removal of toe nail fungus, yet many are advertised as such, including the Cutera Excel V, if I'm not mistaken. It is NOT, however, FDA approved for removal of toenail fungus- it is FDA approved for temporary whitening (or clarifying... please see actual docs to confirm) of the toenail. The FDA issued a warning letter to Cutera making this distinction. Even so, any physician may use any Yag laser for removal of toenail fungus... so long as they do not advertise a make and model on their website because then the label issues come into play. NO ESTHETICIAN ANYWHERE is legally authorized to use a Yag laser for toenail fungus removal.

Once again this is something we estheticians get blamed for, when the real problem is lack of PROPER education and training!

That is true the education is medical school and the training is called residency.

01.14 | Unregistered Commentergm

Florenza, you sound like an idiot.

01.15 | Unregistered CommenterMiamiMD

Although many have a general understanding as to how to use certain devices and know certain indications for a certain treatment, they don't really seem to understand the concept.

02.7 | Unregistered CommenterBartlett

physicians employ estheticians or RNs so they dont have to "waste" their time performing these procedures, they do it to increase thier bottom line. ie out of greed, they are making money hand over fist, and should pay for the proper training of the healthare workers they choose to employ.

03.11 | Unregistered Commentermd esthy

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