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Autoclave Manufacturers Make False Claims About FDA Approvals
Date:7/16/2013

Minneapolis, MN (PRWEB) July 16, 2013

Dental offices, medical clinics and even tattoo and nail salons are being required to use FDA cleared (approved) steam autoclaves, like the Tuttnauer Elara or the Saniclave 200 (retailing currently at about $999). Steam autoclaves such as these are highly regulated and have long been proven to be the most effective way to prevent the transmission of harmful pathogens. Recently, the sterilizer industry has seen the emergence of a disturbing trend, the profusion of small, unregulated autoclaves, almost all of which are being manufactured in China and distributed on Ebay.

"The problem with unregulated sterilizers is that they do not comply with the strict standards and sterilization cycle times that FDA approved autoclaves are forced to meet." Don Tumminelli, manager of Highpower Labs, and a voting member of the ANSI/AAMI ST55 committee stated in an interview, "FDA cleared devices follow strict, comprehensive testing models. The testing data is reviewed and approved by FDA prior to marketing. Sterilizers which have not been subjected to the FDA 510K process and marketed in the US could compromise patient safety."

Distributors of these unregulated sterilizers have been found to intentionally use misleading language in eBay and Amazon ads, such as “Dental, Medical, Tattoo.” Many even dare to use the FDA's name in vague ways, implying FDA approval such as “This product complies with FDA standards...”

Although questionable, the danger of these non-FDA approved autoclaves is not due to a lack of craftsmanship or durability. The real danger lies in the serious liability risk they may pose. “The problem is that they have never passed
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