Thursday, July 11, 2013

Non Medical Personnel Operating Lasers

It never ceases to amaze me how many medical products are marketed for use to the non-medical market. There are so many skin care products making outrageous claims and product manufacturers making claims about their devices and all the while, marketing them to people who cannot legally perform services with the device. This problem is more prevalent today than ever before and this is counter intuitive since there has never been more regulation in the health industry and the FDA has stepped up compliance. 

I have previously written about skin care products that claim to alter and repair DNA (this is really funny because it is so outrageous); other products that claim to treat rosacea (even though when you read the package insert it refers to treating “redness”) and devices that are marketed to the aesthetic market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a medical device being offered to non-medical markets. Other times the problem is that the device is treating medical conditions or the use of the device is such that it constitutes the practice of medicine.

I was reading Day Spa magazine today and I ran across an advertisement that I have seen for MANY years. It was for the Lamprobe. Interestingly enough, I met the owner about ten years ago and asked how he is marketing the device to the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any particular product, but this one typifies the problem.

The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat NONE of these proposed uses. How can this product be ethically marketed to the non-medical aesthetic market when the user cannot legally perform the treatments? Virtually all of these proposed uses are outside the scope of license of an esthetician and they are clearly and squarely within the parameters of medicine. 

Just because a product is marketed to you, does not mean that you are legally permitted to use the product or servoce. The laser companies would gladly sell a laser to my dog Stoli if he would pony up the money!!

Paddy Deighan JD PhD

Monday, July 1, 2013

Connecticut Passes New Medical Spa Regulations

Connecticut is another in a series of states that has taken action in regard to the regulation of medical spas.  The new legislation in Connecticut seems fair and a well thought out effort to protect consumers in the state.
Many within the various related industries, such as aesthetics, believe that the regulation of medical spa procedures it’s a turf battle waged by physicians who are trying to protect their exclusive right to perform cosmetic medical procedures.  However, this law seems appropriate and my vast experience as a consultant to state medical boards and boards of cosmetology is that this type of regulation is borne out of a desire to legitimately protect citizens of a state.
Medical spas in Connecticut that offer cosmetic medical procedures must have an acting medical director who is a state-licensed physician. Bill SB-1067, which goes into effect on October 1, 2013, was passed by the state’s legislature on June 5, 2013. It states that any medical spa that offers procedures defined under the state’s sales tax laws as “cosmetic medical procedures” employ or contract with a medical director. An MD, PA, APRN or RN may perform the procedures. If a PA, APRN or RN is performing the treatment, he or she must be acting under a physician’s supervision and control. In addition, the facility must post notice of the name and specialty of the medical director, and he or she must perform an initial physical assessment of the patient before the procedure is performed. Violators are subject to fines of up to $500 per day while the violation continues.
In my opinion, there will be more new laws such as this one as state’s wrestle with this growing problem.  My only question in regard to this law is whether the nurses have to be employed by the physician. This is a growing issue.

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Paddy Deighan J.D. Ph.D