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Spa Machine Safety
By: Christine Heathman
Posted: June 26, 2008, from the July 2008 issue of Skin Inc. magazine.
page 5 of 9
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.