At the rate our industry is growing, it seems that technology is evolving faster than individual state legislation can keep up with. This often leaves an uncomfortable grey area for estheticians and med spas trying to gage whether or not they can legally perform the latest skin care services. All over the country, estheticians are struggling to find accurate information about what is legally within their scope of practice. Additionally, the rate of production of new devices without proper legislation makes it even harder for estheticians to decide which device is the safest to add to their practice.
When a new device enters the market with the results and science backing it, we cannot help but be eager to add this new tool to our services with the ultimate goal of helping our clients achieve better, faster results. However, often times these devices reach the market faster than each state’s board of cosmetology can debate what the proper licensure to operate these devices should be.
For example, microneedling has fast become one of the most sought after skin care treatments from dermatologists, med spas and small practice estheticians around the country. For years, estheticians were able to offer this service legally, simply because there was no legal yes or no answer. However, in the last year, the FDA has finally defined and classified microneedling devices.
On June 8, 2018, the FDA issued a rule classifying all microneedling devices as Class II devices. The FDA is now defining microneedling devices as “a device using on or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.”
The order issued by the FDA explains that “[the FDA is] taking this action because [it has] determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.”
A Class II Medical Device is defined as one that presents a moderate risk of harm to the user. The FDA identifies the following as risks associated with Microneedling:
- Adverse tissue reaction
- Cross-contamination and infection
- Electrical shock or electromagnetic interference with other devices
- Damage to underlying tissue including nerves and blood vessels, scaring, and hyper/hypopigmentation
While Microneedling is at the top of the hot list of treatments clients are asking for, this new classification might mean that you can no longer legally provide this service.
The FDA’s classification of Microneedling as a Class II device includes all states. However, each state varies in whether or not they allow estheticians to use Class II devices under the scope of their esthetics license.
What’s more, every state differs on whether or not estheticians are legally allowed to use Class II medical devices. Navigating this can be difficult, especially when your main focus is bringing your clients the best possible treatments as soon as they hit the market so they can start seeing results.
Where To Turn
Having a working relationship with your state’s Board of Cosmetology and its board members is vital to not only the safety of your business and your clients, but also for staying current on pending legislation regarding new tools and devices. Familiarize yourself with your state board’s website and where to find all the literature regarding what is currently within the scope of your practice.
Cosmetology schools are also a great resource when it comes to the scope of your license. Instructors are often experts in their state’s legislation when it comes to esthetics and skin care.
When To Say No
Unfortunately, new and trending treatments are often inundating our social media feeds, and clients are more educated than ever on what the latest devices on the market can do for their skin. It is not uncommon for clients to call requesting services like microneedling, unaware of whether the establishment they are calling is legally allowed to perform the service. Clients are often looking for the least expensive service they can find, regardless of the service provider’s level of licensing and experience. It is your job as the esthetician to safeguard your clients and educate them when they come in requesting these types of services. Assure them that you are offering the most high quality treatments legally available. What’s more, remind them that you are responsible for their safety when in the treatment room, and any esthetician who offers services outside the scope of their practice is putting them in danger and should be immediately reported to the state board.
Familiarize yourself with your state board’s website…
Safe Guards
When you find yourself offering services that are in a legal grey area, much like microneedling was before recent legislation, there are a few safety measures you should take when performing these services on clients.
Always keep consent forms on hand for clients to sign before receiving treatment. While these forms do not offer any substantial legal protection, they are a way to ensure that the client is aware of what treatment they are about to receive, and what the possible risks involved are.
Another option is to build a business relationship with a dermatologist or cosmetic plastic surgeon in the area. This way, you can confidently refer clients out to a specialist who can legally perform advanced treatments, while in return you can receive the pre and post care for the physician’s patients. This is a surefire way to not only ensure the legal protection of your client, but also to make sure your clients are getting the best possible results. Although you may lose the revenue from performing these grey area services, you will be gaining your client’s trust in return. And you can be sure that for any service within the scope of your license, that client will recommend clients to you for years to come.
