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Spa Machine Safety

By: Christine Heathman
Posted: June 26, 2008, from the July 2008 issue of Skin Inc. magazine.
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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