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

the rigors of the FDA. Imagine what happens if your facility is inspected and the inspector sees that you are using an unregulated autoclave.” remarked Shane Balkowitsch, a registered nurse and CEO of Balkowitsch Enterprises.

So why are people purchasing these unregulated autoclaves? Price and misleading claims. "Imported, non-FDA approved autoclaves are available on eBay at prices ranging from only a few hundred, to a few thousand dollars. Some even claim to be approved for medical use," states Isaac Erickson of Revolutionary Science. “If you are interested in purchasing an autoclave, look it up by name, using the FDA's website. It is easy to do and can prevent a nightmare down the road.”

The O'Ryan Omega ST is a non-FDA approved product that was actively marketed in the US for over a year, primarily to dentists, tattooists and small medical clinics. After a surprise FDA inspection, the Agency issued a warning letter (SEA 08-28) and the distributor was forced to cease all marketing of the device, states the investigations letter found on the FDA's website. Unfortunately, by this point dozens of Omega ST sterilizers were already sold to the clinical market in the United States. “A clinic can put their patients at risk when using an unregulated autoclave.” adds Chuck Fishelson, a veteran expert in the field and vice president of Alfa Medical.

One of the bigger problems with these devices is that they hold obscure sterilization cycle times. FDA approved autoclaves typically have a standard sterilization cycle of 121C for 30 minutes - the hospital standard. This cycle is long enough to kill the AIDS virus, “MSRA, the flesh eating disease” and all other known pathogens. Obscure, unregulated autoclaves rarely share this standard and rather tend to vary from manufacturer to manufacturer.'/>"/>

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