Issue link: http://cp.revolio.com/i/15024
THE STATE The best advice I can give when purchasing a new device is to obtain and study the Cosmetology and Aesthetic Code of Regulations that pertains to your license in your state. Each state is regulated independently. Therefore, you can not always count on consistency among the codes from state to state. The definition of esthetics by most state code of regulations is something similar to that of the state of California: “… beautifying the face, neck, arms, or upper part of the human body, by means of the hands, devices, apparatus, or appliances, with the use of cosmetic preparations, antiseptics, tonics, lotions, creams …” Regardless of the device, make certain the treatment or service falls within this definition. Equally important, make certain that what, and how, you are advertising also falls within this definition. In order to stay in compliance with state inspections, I highly suggest you keep the verifications for your equipment (noted in this article) printed and organized neatly in a file for state inspectors to review. Keep a product specification sheet and intended use statement from the manufacturer also available in the file for review, as well as your education certificate obtained by the manufacturer. WHERE DO WE GO FROM HERE? Until recently, most states were unaware they have the decision-making power to allow certain devices to be used by a specific licensure. Instead, they usually aimlessly turned to the federal government (FDA) with little, if any, response or direction. Ironically, there is not a state in our country that has specifically allowed, or disallowed, certain classifications of devices to be used by estheticians. The FDA notes in every intended use statement “to be used by a physician or licensed practitioner …” thus allowing the state to decide what they feel is the appropriate licensure. www.ascpskincare.com States are proactively working on solutions and new legislation should remedy some of the ambiguity that currently exists regarding medical devices. Although the question “Am I allowed to use this device?” will likely never be able to be simply answered, take the time to persevere through the verification process and make certain your future device and supplier meet the appropriate criteria. Be proactive and make it a priority to educate yourself regarding certifications, registrations and your state board code of regulations. After all, this is your future. David Suzuki, president of Bio-Therapeutic, Inc., has been an active, licensed member of the esthetic industry for more than 18 years. He joined Bio-Therapeutic in 1992. He serves as an advisor to institutions and state boards regarding FDA and other governing regulatory organizations such as UL, ISO, CSA, and CE. Suzuki writes for numerous industry publications in the United States and abroad. Through seminars and classes, he shares his expertise in marketing profitable antiaging services and educates professionals on practical business strategies and governing regulations. Contact him at 800-976- 2544, dsuzuki@bio-therapeutic.com, or visit www.bio-therapeutic.com. successful business handbook 191