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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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page 7 of 9

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.