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

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