After a surprise FDA inspection, the distributor was forced to cease all marketing of the device.
(PRWEB) November 30, 2012
Increasing state and federal regulations are requiring more and more businesses to purchase FDA approved steam autoclaves. Tabletop sterilizers, such as the Scican Statim, Tuttnauer Elara 9 or the recently approved Revolutionary Science Saniclave 200 (retailing currently at $999) are used in every field, from dentistry to body art. Steam autoclaves such as these have long been proven to be the most effective way to prevent the transmission of harmful pathogens. However, the sterilizer industry has recently seen a disturbing trend, the profusion of small, non-FDA approved autoclaves, many being imported from the Far East.
So what is driving the sales of these non-FDA approved devices? Price and misleading claims. "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," states Isaac Erickson of Revolutionary Science.
"The problem with non-FDA approved devices 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 SPS Medical Laboratories, 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 non-FDA approved 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 is subject to FDA regulations...”
“We feel it is a shame for a dental clinic to potentially put their patients at risk in order to save a few hundred bucks on a non-FDA approved machine.” said Eric Kaari of Revolutionary Science. "The Saniclave 200 carries full FDA approval. It was designed specifically to meet the demand for affordable autoclaves. The American made Saniclave 200 is currently retails for $999.
The danger of these non-FDA approved autoclaves is not due to a lack of craftsmanship or durability. In fact, many of these products are well engineered and built almost as well as the FDA approved models listed above. The real danger lies in the serious liability risk they may pose. “There are many no-name imports entering the United States market that are being unethically and illegally sold for human use. The problem is that they have never passed the rigors of the FDA” remarked Shane Balkowitsch, a registered nurse and CEO of Balkowitsch Enterprises.
In fact, not all non-FDA approved sterilizers are manufactured by foreign companies. Recently, the manufacturer Abtox marketed a non-FDA unit to ophthalmologists. As a result, 18 patients suffered eye problems and one became permanently blind in one eye. The problem was due to a chemical reaction that could have been foreseen, and therefore prevented, if the design had passed the necessary regulatory approvals. The Chicago Tribune stated that the product was recalled and the owners of the company were sentenced to prison time.
The O'Ryan Omega ST is another 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 distributor was forced to cease all marketing of the device, states the criminal investigations letter found on the FDA's website. “The lack of respect for proper testing and manufacturing standards affects the safety of these devices. They put their patients and customers at risk,” adds Chuck Fishelson, a veteran expert in the field and vice president of Alfa Medical.
Servicing a non-FDA approved, foreign autoclave are also problematic. Replacement parts for foreign or non-FDA approved devices have to be ordered from the manufacturer or parts supplier, often located in China. Calibration procedures are also difficult because few of these companies have US representatives.
“Business owners, such as dentists, nail salon owners, small medical clinics and tattoo shops should be cautioned about non-FDA approved sterilizers” said Isaac Erickson of Revolutionary Science. “The likelihood of being sued skyrockets when a pathogen is transmitted to a patient.”
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