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
http://www.medicalandspaconsulting.com

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.

http://www.aol.com/article/2015/08/17/footprints-of-dinosaurs-strolling-on-the-beach-found-in-germany/21223733/?icid=maing-grid7%7Cmain5%7Cdl23%7Csec1_lnk3%26pLid%3D175989300

Have a wonderful day, 

Paddy Deighan
http://www.medicalandspaconsulting.com

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 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 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 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

http://www.medicalandspaconsulting.com

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 Medicalandspaconsulting.com

Paddy Deighan J.D. Ph.D

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

Lasers May Repair Teeth...No More Fillings and Cavities and Root Canal!!

For the millions of Americans who suffer cavities each year, the ominous threat of a root canal may soon be a worry of the past.

Now, researchers from Harvard University claim they have discovered a novel way of regrowing parts of people’s teeth using an unlikely tool: Lasers.

In a new study published in the journal Science Translational Medicine, lead researcher Praveen Arany and colleagues detailed how they used focused laser light therapy on rats to stimulate the growth of lost dentin, the calcified tissue that comprises teeth.  They noted that if the therapy proves effective in humans, it could potentially eliminate the need for crowns, fillings and other complex dental operations in the future.

The procedure’s success all revolves around a native protein called transforming growth factor beta, or TGF-beta.  During preliminary tests of dentin tissues, the researchers discovered that this growth factor changed very drastically when introduced to a focused beam of light.  Further analysis revealed that when hit with light, TGF-beta actually stimulated the stem cells already present in dentin.

“Once [TGF-beta] is activated by the laser, it can bind to stem cells resident in the tissue, and then it induces those stem cells to differentiate so they can proliferate and reform dentin,” David Mooney, the Pinkas Family Professor of Bioengineering at Harvard University, told FoxNews.com.

Numerous studies have focused on ways to manipulate stem cells in order to spur tissue regeneration, but most of these techniques have revolved around reintroducing altered stem cells into the patient or directing stem cell populations externally through added growth factors.  With this form of laser therapy, the only external factor that is being introduced is light, which activates TGF-beta that’s already in the body.

According to Mooney, it’s not the laser’s heat that stimulates TGF-beta but the energy of its photons.  When light is focused on dentin, the photons get absorbed into the tissue and activate molecules called reactive oxygen species (ROS), which naturally occur in the body.  These ROS then stimulate TGF-beta, which spurs the chain reaction ultimately leading to dentin reformation.

However, Mooney noted that the power of the laser must be at a specific level of intensity and cannot produce any heat in order to be effective.

“It’s kind of like Goldilocks, too little won’t do enough and too much will become destructive,” Mooney said. “It has to be just right.”

To test their light therapy’s effectiveness, the researchers created a group of rats with tooth defects, by using a drill to remove pieces of their dentin.  They then shined a laser on their exposed tooth structures and soft tissues underneath it.  Sure enough, after 12 weeks, the team observed that new dentin had formed in the rats’ teeth.

Given their trial’s success, Arany and his team hope to test this type of dentin regeneration in human clinical trials, which could potentially alter modern dentistry.  Currently, if a patient has a chipped or decayed tooth, dentists will use synthetic materials to fix the problem or perform a root canal if the tooth has become too infected. Yet, Arany noted that laser therapy could erase the need for these uncomfortable dental procedures, simply by regrowing the part of the tooth that is missing.

He also noted that focused laser therapy could be used to grow more protective dentin in teeth that have grown sensitive due to gum recession.

“As we grow older our gums recede, exposing our teeth root,” Arany, assistant clinical investigator for the National Institutes of Health, told FoxNews.com. “The root is covered by cementum, which is not as protective as enamel, so you get dentin sensitivity….What we hope is in tooth sensitivity, [laser therapy] is able to generate an intrinsic protective barrier on the inside of the tooth.”

Expanding beyond the world of dentistry, the researchers note that TGF-beta is found in other bodily tissues, such as skin and bone, and that laser therapy could potentially help regrow tissues in those systems, as well.  Also, since TGF-beta is known to control tissue inflammation, the growth factor could perhaps be stimulated to control certain inflammatory diseases.

But for now, the team is focused on TGF-beta in relation to teeth, and they are hopeful that their laser therapy could be used in a clinical setting relatively soon.

“This laser is already a big part of the clinic, since so many of the clinicians use it for other purposes,” Arany said.  “So the barrier to clinical trial translation is relatively low.”

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

Psoriasis Now Recognized as a Serious Health Concern

At the 67th World Health Assembly, the World Health Organization (WHO) member states adopted a resolution on psoriasis, recognizing it as “a chronic, non-communicable, painful, disfiguring, and disabling disease for which there is no cure.” The resolution also acknowledges the psychosocial burden of the disease and that many people with psoriasis suffer due to lack of awareness and access to sufficient treatment.

Lars Ettarp, president of the International Federation of Psoriasis Associations (IFPA) comments:

“IFPA, together with its member associations and leading medical societies, has long called for the WHO and its member states to recognize the serious nature of psoriasis. Finally, the voices of the more than 125 million people who live with psoriasis have been heard, and on this historic day for the global psoriasis community we wish to express our great appreciation for all the stakeholders involved in bringing about this important resolution, especially all the WHO member states that have shown their support for our cause.”

Panama is one of the WHO member states that has actively supported the resolution and the campaign for recognition of psoriasis. HE Ambassador Alberto Navarro Brin of the Permanent Mission of Panama to the United Nations in Geneva, states:

“Together with Argentina, Ecuador and Qatar, Panama recognized the need for greater awareness of this disease which has such a major impact on the health-related quality of life for its sufferers, and initiated discussions with other WHO member states to gain their support. We are very pleased that this resolution has now been adopted and will continue to work with civil society to help build a better world for people with psoriasis.”

One of the stakeholders that have engaged with IFPA in advocacy for global recognition of psoriasis is the International League of Dermatological Societies, ILDS. Professor Wolfram Sterry, the President of ILDS, comments:

“As a dermatologist I have seen first-hand how deeply psoriasis affects people in their daily lives, as have the many members of our worldwide organization. Together with the psoriasis patient associations, we have been able to educate policy makers on the impact this disease has and what can be done to ease its burden. This resolution gives us a platform from which we can engage even further with policy makers to help improve access to the treatment and care that people with psoriasis need and deserve.”

Kathleen Gallant, Secretary of IFPA and Chair IFPA Task Force on NCDs, agrees that the resolution is an important platform from which to effect change:

"The adoption of the psoriasis resolution by the 67th World Health Assembly sends a powerful, global message that psoriasis is a serious immune-mediated, painful and disabling NCD that needs greater public awareness of its inflammatory nature, many physical and psychosocial impacts and shared risk factors with other, more deadly NCDs. This is a great opportunity for education and greater understanding, making a tremendous collective first step towards alleviating the devastating effects of this chronic inflammatory disease."

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

A Contrarian View of Free Radical Theory

Past research has suggested that free radicals - occasionally harmful molecules produced by the body as it processes oxygen - contribute to the aging process. But new research from McGill University in Canada finds that free radicals may actually increase lifespan rather than shorten it.

Free radicals, also known as oxidants, are unstable and highly reactive atoms that have at least one unpaired electron. They can be formed naturally in the body or can be introduced into the body from external sources, such as smoking or pollution.

When free radicals interact with cells, proteins and DNA in the body, they can cause damage by modifying their chemical structure. Past research claims that constant cell exposure to harmful free radicals over time causes aging. But this latest study, published in the journal Cell, suggests otherwise.

The research team, including senior author Siegfried Hekimi of the Department of Biology at McGill, used a model organism - the roundworm Caenorhabditis elegans nematode - to reach their findings.

Findings 'turn theory of free radical aging on its head'

The researchers discovered that free radicals can stimulate apoptosis, also referred to as "programmed cell death" - the process by which damaged cells "commit suicide." They may do this to avoid becoming cancerous, for example, or to destroy viruses that have taken over the cell.

The team found that when free radicals stimulate apoptosis in a certain way, the cells' defenses are reinforced, meaning their lifespan is increased.

Explaining the team's findings further, Hekimi says:

People believe that free radicals are damaging and cause aging, but the so-called 'free radical theory of aging' is incorrect.

We have turned this theory on its head by proving that free radical production increases during aging because free radicals actually combat - not cause - aging. In fact, in our model organism we can elevate free radical generation and thus induce a substantially longer life."

Hekimi adds that demonstrating the molecular mechanism by which free radicals increases the lifespan of cells provides solid evidence that they have positive effects as signaling molecules.

Furthermore, he notes that the findings mean that apoptosis signaling may be used to trigger processes that decelerate aging.

"Since the mechanism of apoptosis has been extensively studied in people, because of its medical importance in immunity and in cancer, a lot of pharmacological tools already exist to manipulate apoptotic signaling," adds Hekimi. "But that doesn't mean it will be easy."

He says that such a process could be important in neurodegenerative diseases. He explains that apoptotic brain signaling may be focused on increasing the resistance of damaged cells rather than destroying them, since it is more difficult to replace dead neurons than other cell types as a result of the complexity in their connections.

Paddy Deighan, J.D. Ph.D

http://www.medicalandspaconsulting.com