Wednesday, August 26, 2015

When are Spa Services Considered to be Medical Treatments

I have written many articles on what services are medical and which ones are spa.  Despite what appears to be a clear line, there is a lot of questions concerning this distinction. I respond to many threads on LinkedIn as they relate to this topic and I am a bit surprised at the misinformation and lack of understanding that medical treatments may only be performed in a "medical" environment.

Accordingly, I can add some additional thought to further clarify the distinction between spa and medical treatments.  If a product or service is such that the implements or device used in the treatment requires  or is recommended for sterilization, then the service is almost always medical.

I recently read a review of a micro-needling device.  The device suggested that the components be sterilized in an autoclave after use. This all but assures that the treatment is medical. If there is any possibility of infection or transmission of pathogens, then a treatment will be considered medical. You may recall from prior articles that I have written, that there are two many issues in regard to whether a product, treatment, or service is medical : 1). is the treatment or product intended to diagnose or treat a medical condition and 2). is there a medical device being utilized in the delivery of the treatment.

Professionals constantly say to me that the manufacturer states that the service or device is not medical.  The New Jersey in me would respond that it is not their license on the line when they state that.  From a more practical view, you can review the FDA position on a device.  Ask the manufacturer if the device is a Class II or higher medical device.  The FDA indication will be visible on the device packaging or the device itself. If the device is Class II or higher, it does not matter what the manufacturer is telling you - the device IS by its FDA clearance, a medical device.

In one instance, an esthetician advised me that her state cosmetology board advised her that it is acceptable for her to perform micro needling.  My response was that she needs to ask the medical board (or nursing board) and the FDA.  She will receive different answers from those entities.

As I am known to say..."the answer you receive depends upon the question that you as and with whom you inquire".

Paddy Deighan J.D. PhD

Tuesday, August 18, 2015

Not Medically related but REALLY Interesting!!!!

We are all a bit if Jurassic history nuts so I had to pass this along.  Dinosaur footprints were uncovered in a beach in Germany.  Accordingly, there are a number of interesting aspects to this:

1). The dinosaur footprints are estimated to be about 140 MILLION years old;
2). It appears that dinosaurs were more social than previously believed;
3). Germany has beaches AHAHHAHAHAHAHA

It is truly astounding to discover footprints that are 140 million years old.  After all of that time, they came to the surface between 2009 and 2011.  Why now? Can you imagine the series of events during the past 140 million years?

Stories such as this are fascinating to us..

Actually, upon closer inspection, maybe this story is about medical spa issues.  It certainly appears that our Jurassic friend needs a mega dose of Botox Cosmetic!!! ahahahahaha

Here is a link to the original story.

Have a wonderful day, 

Paddy Deighan

Monday, August 17, 2015

Which Medical Spa Treatments can an Esthetician Perform?

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 Pseudofolliculitis 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 polycystic 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

Time for Another Look At Employee Contractor Status in Medical Spas

The employee/Independent contractor scenario in spas and medical spas is very complex. The determination of whether a professional staff member is an employee or independent contractor is not easy to address. One thing that IS clear; the agreement that may be in effect is not the most significant issue. You can classify a professional staff member whatever you want to call them in an agreement, but this does not control the ultimate determination.

Many owners and professional staff want to be independent contractors but the reality is in many cases, the relationship is not sustainable. The Internal Revenue Service (IRS) has been looking at the spa industry more closely (possibly due in large part to tipping structures, but they are looking at the industry). The Service has been looking at many “tip” based businesses such as the taxi industry, restaurants and salons and spas.

The IRS has ruled sometimes that an independent contractor was really an employee because the business supplied TOWELS and LINEN! WOW!

A fundamental approach will be based on two key aspects of the relationship: 1. "control" over the professional staff members hours and days of service, and 2. requirement to utilize certain product lines or practice policies and protocols for certain procedures.

These are not easy issues to address because there are conflicting issues and goals. On one hand, the medical spa needs staff to be available during operational hours. It would be problematic to allow professional staff to decide the days and hours of service. However, providing schedule is a strong element of “control” over the staff member and this tends to be an employment situation.

The second issue is no less problematic.  A professional staff member may support a certain product line that is not offered by the facility. He or she may have a different protocol for a procedure.  The professional staff member may have his or her own protocols for a procedure – even something as seemingly straight forward as micro-dermasbrasion.  An ancillary concern is when there is a mixture of employees and contractors. The contractors may have more freedom to perform services and procedures and they deem appropriate and this can cause staff problems.

I address many such issues every day and please see my website

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.comMedical and Spa Consulting