Disclaimer: In some states, only medical professionals are allowed to perform procedures. Each state has specific governing rules and it is your responsibility to contact the proper governing body for approval before using any of the featured equipment.

 

DEFINING AESTHETIC EQUIPMENT

Defining Aesthetic Equipment
By David Suzuki
Dermascope, Nov 04, (pages 65-74)

Am I allowed to use this device? This seemingly simple question is in reality quite complex to answer when considering implementing new equipment into your aesthetic business.

Although the FDA is the most rigorous, prominent and feared organization that exists in the United States in regards to the regulation of medical devices, it is fair to say that verifying the FDA status of a prospective supplier and device, is only the tip of the iceberg in your responsibility of due diligence.

There are many different facets to consider while in search of the "latest and greatest" technology that the market has to offer. It is a good idea 10 consider each one of the points in this article to insure that the new technology that you are considering has been safety tested, is a legally marketed device, is manufactured by an insured and legally registered FDA Medical Device Manufacturer, and the equipment is legal to be used by a licensed aesthetician in your state.

For simplicity, I have broken the verification process into three simple categories for you to consider:

The Manufacturer
The Device
The State

THE MANUFACTURER
FDA
It is important to consider that nearly every device that comes in contact with a human being falls under the umbrella of the US FDA as a medical device. A medical device is defined as "An instrument, apparatus, implements, or machine intended to affect the structure or any function of the body of man or other animal:"

This includes devices such as a vibrating back massager that can be purchased at a department store, microdermabrasion devices used by professional aestheticians, and pacemakers implemented inside the human body. The FDA maintains three classifications for medical devices; Class I, Class 2, and Class 3. The classification of a device is determined by the intended use of the device, the invasiveness of the device, and the level of public risk that the device may pose. The back massager and microdermabrasion devices are examples of Class 1 devices. LED Light Therapy and EMS devices are examples of Class 2 devices, and a pacemaker is a good example of a Class 3 device.

Regardless of the classification of a device, every manufacturer, domestic, and international, is required by federal law to be registered with the US FDA and declare what kind of device(s) the manufacture. The statement “we do not make medical claims and therefore we do not have to deal v FDA" is simply NOT TRUE.

With this in mind, the first stop in your verification mission is the FDA website to insure that the device you a considering is manufactured legally under the general controls set forth by the US FDA Good Manufacturing Practices. This can be verified at the following website: www.fda.gov/searcbases.html

PRODUCT LIABILITY lNSURANCE
Product Liability Insurance is insurance that manufacturers obtain specifically to insure coverage and protection for individuals and companies who use products and manufactured by them. This insurance provides coverage the event the product or device fails or malfunctions damage or harm.

Note that Product Liability Insurance is different then General Liability Insurance. General Liability Insurance is typically for the building or property that a business operates in, and protects against damage, theft, and liability claims that may arise from injuries such as a person slipping on a banana in your lobby.

Product Liability Insurance is something that many manufacturers simply do not carry. In many cases it is due to the expense as it can range from $40,000 per year, to upwards of $250,000 per year. In other cases it is purely because they cannot obtain it, regardless of the cost. Most insurance carriers require that a manufacturer meet certain criterion being an FDA Registered Medical Device Manufacturer, ISO Registered, UL Registered, CSA Registered, etc., to insure that they are dealing with a responsible and well-run company. In fact many insurance carriers will not even supply a quote for Product Liability Insurance unless the above mention certifications and registrations exist as it simply allows too much liability exposure.

Every insurance policy has what is referred to as a “Dec Page" or "Declaration Page". The declaration page is usually the top page of every insurance binder that sums up the coverage that is painfully explained in the insurance binder. Ask your potential supplier for a copy of the declaration page. When you receive their declaration page, there are several points to look for; Confirm that it is a US policy, that the date range confirms that it is a valid policy, that the manufacturers name is on the policy as the insured, and that the device or product you are considering purchasing is listed as one of the products or devices insured under this policy. If you have questions or require clarification, it is a good idea to contact the insurance carrier directly.

Manufacturing equipment without liability insurance is as negligible as driving without insurance; definitely not recommended.

ISO
The purpose of ISO (International Organization for Standard) is to facilitate the International coordination and unification of industrial standards. For consumers, ISO ensures conformity of products and services, providing assurance of their quality, safety, and reliability.

ISO is the most respected organization in the world in regards to quality customer service, business operations, customer satisfaction, manufacturing practices, dealing with quality vendors, etc. Although being ISO Certified is not federally mandated as is FDA, the prestige and quality that ISO Certified

companies represent are more respected than that of any other organization in the world due to their strict policies and frequent audits.
There are two levels of ISO certification that you should be looking for in a prospective supplier; ISO 9001:2000 and ISO 13485:1996. ISO 13485:1996 is a certification that was specifically developed for medical device manufacturers and mirrors the rules and regulations set forth by the FDA Good Manufacturing Practices.

ISO 13485:1996 is extremely important for us in the aesthetic arena, as most aesthetic devices are considered Class 1 devices by the FDA, and as such considered "not significant risk'. Most manufacturers of Class 1 devices are not consistently inspected by the FDA, where as ISO inspects twice per year and has no obstacles with budget cuts.

ISO 9001:2000 certification is applicable to all types of businesses whether they manufacture medical devices, air- planes, or widgets. This certification is applicable to both small manufacturers that have as few as one to three employees, to very large manufacturers such as Boeing. ISO 9001:2000 is based around a sound, responsible, quality management system with complete Standard Operating Procedures that support this quality system. Audits may include anything from customer service records and post market surveillance records to insure that customers are satisfied with the company's performance, to building maintenance records insuring that the facility is cleaned on a regular basis making certain that a sanitary, safe work environment is maintained.

ISO certifications are the most prestigious certifications hat a manufacturer can obtain. As such, any company that proudly illuminates the ISO symbol on their marketing material or advertisement literature should be recognized as a "top shelf”, high quality manufacturer. ISO certifications can be verified at www.ul.com

THE DEVICE
FDA
The specification sheet of any device you are considering should declare the Class (1,2 or 3), the product Code and the Commercial Name of the device.

Remember, every aesthetic device is considered a medical device. Every manufacturer of a medical device is required to be registered with FDA as a Medical Device Manufacturer and to declare what class (1,2 or 3), Product Code, and Commercial name of the device(s) that they manufacture. During the verification process you may find the phrase “multiple device” rather than the name of the device. This is acceptable, and simply means that the company manufactures multiple devices within the category and class, that bear different names. This information can be verified at the following FDA website: www.fda.gov. Because of their “non-significant risk” status, Class 1 devices are exempt from FDA 510K submission, and therefore do not have an FDA 510K number. Class 2 and Class 3 devices are required to have a 51 OK number or a PMA number (Pre Market Approval). Most aesthetic and end consumer devices fall into the Class I category. Some Class 2 devices may be allowable to be used by aestheticians without the supervision of a physician, however, anything Class 2 or higher should be closely reviewed along side your state board code of regulations.

UL
UL (Underwriters Laboratories) is a trusted source across the globe for product compliance. The UL Safety Certification process insures that every part used to manufacture the device, and the device in its entirety, has been tested to the highest quality standards; IEC/UL60601-1. UL performs every test imaginable including operating the devices for prolonged periods of time, insuring that the device performs within the manufacturers engineering specifications, insuring that every part is tested or UL Listed individually, literally burning the device, dropping the device, hitting and smashing the device, etc. When a device returns from UL testing, it looks like it has been through a war!

To insure that each manufacturer maintains this quality, UL auditors visit the manufacturer's facility twice yearly and inspect the Master Device Records. The auditor also dissects a working device to insure that the manufacturer has not altered the designs or quality of manufacturing or parts since the UL certification was achieved.

UL Safety Certification is extremely, important for us the aesthetic world as Class 1 devices are exempt from UL 510K submission, and therefore escape mandatory UL Safe Certification. Class 2 devices require a 510K submission and approval before legally entering the US market. Part of an FDA 510K is a required UL Safety certification (CSA) insuring that the device is manufactured correctly and safely. Many people believe that if a device is FDA registered and the manufacturer is FDA registered, that the device is of sound quality; not correct, specifically for Class 1 devices. UL Safety Certification or a like kind safety testing certification is absolutely necessary. UL safety certifications can be verified at:

http://database.ul.com/cgi-bin/xyv/template/lisext/1frame/geosrch.html.

CSA (Canadian Standard Association) is a parallel safety testing organization and a competitor of UL. In most cases they test to the same or similar safety standards, and are usually both accepted by FDA as adequate safety testing. However, UL is most prestigious of the two, and the most widely accepted worldwide. CSA safety certifications and be verified at: www.ul.com
CE is similar to UL and CSA, and is required for devices that are to be sold and distributed throughout the European Community. However, beware as the CE mark for Class 1 devices is a “self declaration” (no testing required) by a manufacturer, stating that they meet the applicable safety standards. UL and or CSA are the minimum safety registrations that you should look for when considering purchasing a new device.

COSMETOLOGY CODE OF REGULATIONS
One of the most important things to do 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, and therefore you cannot always count on consistency amongst the codes from state to state.

The definition of aesthetics 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 that you are considering moving forward with falls within your states regulations. Equally as important, make certain that what, and how you are advertising does not stretch outside your parameters.

In order to stay in compliance with state inspections, it is highly suggested that 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?
Up until recently, most states were unaware that they themselves have the decision making power to allow certain devices to be used by a specific licensure within their state. 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, in their CCR certain classifications of devices to be used by aestheticians or even refers to classifications of devices. 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.

Although greatly in the rears, states are proactively working on solutions and new legislation that will hopefully 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 answered simply, take the time to persevere through the verification process and make certain that your future device and supplier meet the appropriate criterion. Be proactive and make it a priority to educate your self-regarding certifications, registrations and your state board.