Imported, non-FDA approved units 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
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 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.
Servicing a non-FDA approved, foreign autoclave is also problematic. Replacement parts for foreign or non-FDA approved devices have to be ordered from the manufacturer or parts supplier. They are often located in China and can be troublesome and expensive to obtain. Calibration procedures are also difficult because these companies rarely have US representatives.
For more information on FDA approved sterilizers, such as the Revolutionary Science Saniclave 200, Scican Statim or the Tuttnauer Elara 9; or to check if an autoclave is approved, visit the FDA's website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
About Revolutionary Science
In 1999, Revolutionary Science was founded after the birth of the company's first micro centrifuge. Years later, Revolutionary Science designs and manufactures incubators, centrifuges, autoclaves, automated cell and colony counters and water baths.
Registered with the FDA and ISO, Revolutionary Science is a Minnesota company dedicated to the manufacturing of precision life science and sterilization equipment.