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Spa Machine Safety

Christine Heathman July 2008 issue of Skin Inc. magazine
high tech facial

Stroll into any beauty trade show, examine an esthetic journal or browse the Internet on the topic of skin care equipment, and you will likely be deluged with devices proclaiming effectiveness in everything from clearing acne, stamping out pigmentation, erasing wrinkles, replacing face lifts and aiding with a variety of other issues. All this information is calculated to make you believe and trust in these companies, and given this knowledge, many are only spawning clever marketing tricks by means of expensive advertising and fast-talking salespeople.

In reality, the ever-changing skin care jungle can be comprised of the empty technology of high-speed words and junk science paired with anecdotal noise woven into chaotic complexities and claims that even the most savvy skin care specialist is unable to comprehend or determine factual. Learn what to look out for—and what consititutes a warning sign.

How to know what works

Before you spend your investment dollars on any skin care equipment that could simply become another piece of furniture in your spa, do your homework to ensure your new asset falls in line with the U.S. Food and Drug Administration (FDA) and is backed by scientific research and documentation—not just marketing hype. Make certain your skin unit meets the specific operating requirements of your state’s licensing rules as well, especially in the case of intense pulsed light and photofacial machines. This equipment can be considered class 2A medical and is restricted with respect to operation.

Having said this, the good news is that a handful of credible skin equipment manufacturing and distribution companies actually offer scientifically corroborated clinical studies, FDA proof of registration, safety, efficacy, long-term results documentation and, just as importantly, a business history of substantial income increases that will help you to grow your business.

Albert M. Kligman, MD, PhD, a renowned dermatologist with the University of Pennsylvania School of Medicine, stated at a past advanced skin seminar, “Instrumentation is a legitimate form of treatment.” Noting those words, the choices of skin care instrumentation can not only become a financial challenge to the skin care specialist, but are also mired in a world of credibility confusion.

It has always been of great consequence to review your equipment purchase thoroughly, but in today’s economy and competitive world where the skin care specialist needs a point of difference, selecting the right device is even more central to your business. Before you invest in skin care equipment that avoids the cheap knock-off or look-alike machines, make certain you are purchasing a device substantiated by clinical trials, science and FDA registration. In other words, do your homework.

Knowing the FDA

The first step in ensuring the integrity of a skin care machine is to understand FDA classifications and device regulatory requirements. Unraveling the dynamics of the FDA in this area is a skill that rests upon its own merits; however, this article will attempt to translate these rules into a common, simple language everyone can understand.

The history of the FDA is an interesting part of our nation’s times gone by. Many forces combined to create the need for the 1906 Food and Drugs Act, which, on June 30, 1906, President Theodore Roosevelt signed into law. The law’s relevant background in America starts with colonial food statutes concerned with bread and meat. The first national law came in around 1848 during the Mexican-American War, banning the importation of adulterated drugs, a chronic public health problem at that time.

One way to structure this intricate story is to consider the seven Cs—change, complexity, competition, crusading, coalescence, compromise and catastrophe. Since the origin of the FDA’s branch of authority, many arms of the organization have evolved. The FDA is a division of the U.S. government’s Department of Health and Human Services located outside Washington, D.C., in Rockville, Maryland. It oversees five main areas: veterinary medicines, food safety and nutrition, drug evaluation and research, biologics evaluation and research, and medical devices and radiological health.

To get into detail about the structure of the FDA, more information can be accessed via its Web site at www.fda.gov. And to understand the FDA, it’s necessary to comprehend the following departments, although not all the following areas mentioned apply to esthetics.

  • Center for Veterinary Medicine—Reviews all medicine approved for animal use, including medicine that is used in animals for human consumption
  • Center for Food Safety and Nutrition—Supervises most foods in the United States together with imported foods
  • Center for Drug Evaluation and Research—Ensures safe and effective drugs are available to Americans
  • Center for Biologics Evaluation and Research—Ensures biological items such as blood, vaccines and biological therapeutics enhance the public’s health
  • Center for Devices and Radiological Health—Ensures the safety and efficacy of medical devices

The FDA regulates these things to ensure the safety and efficacy of products in all these areas through a set of laws with respect to safety and claims, and these regulations are different from statute laws.

In today’s rapidly changing face of professional products and machines falling under the auspice of the FDA, many argue this organization is underfunded, incompetent, the victim of regulatory capture and staffed by lifetime bureaucrats more interested in preserving their jobs than protecting the public health. Quite possibly this is true given several temporary hiccups in the system. The FDA is in many ways outdated and challenged by offenders who fly temporarily under the radar until reprimanded.

And because of this, it has become the professional responsibility of the skin care specialist to ensure the manufacturer or distributor of the skin care machine they choose to purchase has taken the correct and appropriate legal steps to comply with the FDA safety register standards. As you all should know, this is a buyer beware market.

Credible technology

Manufacturers work through a process with the FDA to ensure disclosure of the information needed to determine the safety and effectiveness of a technology. Before purchasing a machine, ask for all the data available on the unit, in addition to clinical studies. This statement does not mean you are entitled to company proprietary information; the purpose of this request is to ensure your device is, if necessary, registered with the FDA and to acquire the documents to back its effectiveness.

The sad reality is not all skin care machine manufacturers follow this guideline. The skin care industry is on the FDA’s radar for competency, as noted by the many ingredient-listing changes imposed in the last few years and offending companies that have been cited for violating regulatory laws. There are thousands of skin machines currently on the market not registered with the FDA, and yet they are marketed as “regulated” by the organization, piggybacking on the credibility of trustworthy and honorable companies that have gone to the expense of following regulations and abiding by the law.

Important to this statement is, if you have invested in a skin care machine that falls outside the regulatory guidelines, a recall could impact your business. You should weigh if this is worth the risk before choosing a skin care machine to purchase.

Regulations based on technology

Individual technologies are unique. Responsible regulation must weigh product benefits against product risks. In all instances, upholding client safety and improving lives comes first, so, recognizing the diversity and complexity of devices, the FDA tailored the following review system to be appropriate for the individual pieces of equipment.

Always ask what class the device you are being sold falls into. Based on experience and observation, if a skin device does not have an active FDA classification, you should definitely be asking yourself about the actual effectiveness of the appliance.

The three-tiered class system allows the FDA to appropriately match the level of review with the individual device and has become the model for machine technology regulation worldwide, an interesting caveat given that many foreign manufacturers sell their skin devices in the United States.

Class I covers simple devices, such as microdermabrasion and low-dose ultrasound, that generally do not need premarket studies. However, many companies committed to the sciences do take this additional step. Class I devices pose a very low risk and account for approximately 30% of all devices on the market.

Class II includes surgical instruments, patient monitors, catheters, diagnostic imaging equipment, x-ray machines and so on. These are proven technologies with well-known and well-understood safety profiles. They pose either a low or moderate risk to the patient, and therefore are typically approved with premarket notifications, also known as 510(k)s. Manufacturers must show Class II devices are “substantially equivalent” to other existing, legally marketed medical technologies that have a proven track record in the marketplace, and most medical devices, or approximately 60% of them, are categorized as Class II.

Class III covers breakthrough devices such as artificial heart valves, coronary stints, novel diagnostic tests, bioartificial skin and spinal implants. Class III devices pose a higher risk and must undergo an exhaustive approval process to ensure patient safety, leading them to account for around 10% of medical technologies available.

After FDA approval

The safety process doesn’t stop once technologies are approved though. FDA guidelines are the standard to be met, but goals to ensure efficacy should be set higher with the advancement of science and technology. Once the FDA approves a technology, companies follow strict manufacturing controls to ensure the devices produced will continue to be safe and effective throughout their entire lifespan—from design to preproduction to full-scale production and long after.

Manufacturing companies of skin machines should be held to a high standard and tightly control each of these steps, continually collecting information to improve their processes and products.

UL-tested and approved

In addition to FDA management, there is also a harmonized standard for electrical medical equipment, such as UL and other safety guidelines. Your skin machine should list a worldwide series of standards, and UL is similar to Good Housekeeping magazine’s Seal of Approval, making it often used as a base line. UL stickers on the outside of machines were required to be there by or before Sept. 1, 2007, in order to comply with insurance requirements.

And there are other ULs that hold to a higher quality, such as EN 6060-1-1, and this is really the main code to look for.

More information on UL and electrical approval.

Warranty watch

One important issue the FDA does not regulate is the guarantee of the machine. These are some questions to ask before you buy any skin care device in order to help you make this important purchase decision:

How does the company respond if there are problems? Advanced skin technologies have enriched the lives of millions and elevated the credibility of the skin care industry to a new level of expectation for results. However, even the best machine is not without a downtime, and aside from FDA standards, when problems do occur, does the company work quickly to resolve them? Does it possibly provide a loaner machine?

Reported problems—and the appropriate response—can vary widely depending on factors, such as the type of product. Problems do affect a percentage of devices; however if the machine is purchased from a foreign country, it is extremely important to understand their policy of repair, as sometimes a product must be returned to the manufacturer. You could lose thousands of dollars in treatment revenue if the machine has to be sent out of the country for renovation, taking weeks or even months to get it back into circulation.

And if there is an out-of-warranty cost to repair the machine or parts not covered, get an estimate beforehand so there are no surprises. Otherwise, you could be liable to pay as much for repair as the original cost of the machine.

What happens in a recall? Reputable machine manufacturers will always take a proactive approach to safety, which is why 99% of recalls are voluntary and generally are initiated by the company. If it is determined that a machine may pose a risk to public health, either the manufacturer or the FDA can have the product removed from the market.

What is the process to recall a product? A proactive approach to safety is why 99% of recalls are voluntary and initiated by the company. If it is decided that a recall is necessary, FDA regulations outline detailed step-by-step procedures for manufacturers to follow in conducting timely, complete recalls. These procedures include performing an evaluation to determine the health risk posed by the product, developing a strategy to complete the recall and periodically submitting recall status reports to the agency.

Manufacturers are required by law to report to the FDA when they initiate a recall for a problem that poses a risk to patients’ health for Class I and Class II machines. Many companies go beyond this requirement and voluntarily report the least serious, or Class III, recalls as well. Ask your manufacturer if they’ve ever had a recall—and if so, why and how it was handled—before deciding to purchase a product.

Does the manufacturer keep track of all its devices on the market? This is a voluntary procedure, but if a company is organized enough to keep records of the primary purchaser of each of its products, this is an indication of the company’s attention to detail importance.

Does the manufacturer sell on e-Bay or Amazon outlets, or allow the sale of its machine to a gray market? The practice of this marketing channel can be a problem when a professional Class I or Class II device is sold to unlicensed and untrained people. Even the safest Class I or II device can pose a huge risk when in a layperson’s hands, so note: Does your manufacturer ensure its machines are pulled off these sites and the host alerted to the potential risk? How does the manufacturer help police this system to protect the industry?

The use of the Internet to buy medical and medical-type products is growing rapidly. Many consumers benefit from the convenience and privacy of this new option, but it can quickly lead to misuse and abuse of appliances. Unfortunately, the rogue sites of fraudulent or disreputable Internet businesses selling these products illegally are now threatening consumers’ safety.

While the FDA is working to combat these illegal sites, skin care specialists can help educate their clients to avoid this practice by informing the public about receiving treatments only from licensed, trained individuals qualified to perform the procedure.

Does the manufacturer have a warranty? Get this in writing. Do not take a salesperson’s word your machine has a warranty, and read the fine print to know what is covered under this insurance. A reputable manufacturer will also keep records on your machine and will have its productive life tracked in their system.

Knowing, practicing and staying safe

When purchasing a skin care machine to be part of your spa’s offerings, it’s important to check out all of the devices you’re considering investing in to ensure both you and the unit are in compliance with the proper laws and regulations. Not all machines are created equal in the skin care industry, and the reality is that, just because a salesperson states something as fact, that does not mean it is the truth. Learning how to correctly identify what is truthful and proper sets you and your business that much higher up in the industry.

Advanced skin technologies have enriched the lives of millions and elevated the credibility of the skin care industry to a new level of expectation for results. However, even the best machine is not without a downtime, and aside from FDA standards, when problems do occur, does the company work quickly to resolve them? Does it possibly provide a loaner machine?

 

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