Not all medical mistakes occur because of errors on the part of hospital personnel. Some problems can be traced all the way to unscrupulous manufacturers of healthcare products.

Two executives of a Mundelein, Ill., company were convicted in April 2006 of mis-marketing sterilizing equipment for hospitals. When their equipment was then improperly utilized in the hospital settings, eighteen patients lost eyesight in one of their eyes.

The company named AbTox received permission to market a small sterilizing device intended only for flat stainless-steel surgical instruments. Instead of selling the approved item, the company released a larger (and unapproved) version of the sterilizer and promoted its use for a wide array of non stainless-steel instruments. Sales personnel for AbTox showed prospective buyers of this larger machine a fraudulent clearance letter that was really only intended for the smaller sterilizer.

One hundred sixty-eight of the unauthorized units were sold to hospitals nationwide, including Department of Veterans Affairs hospitals and other government agencies, totaling over $18 million in sales.

One of the problems with the unapproved model was that when it was used to sterilize complex instruments used in the treatment of cataracts, brass fittings in the machine would react with the sterilizing agents and deposit a toxic residue on the instruments. This residue caused blindness in eighteen unfortunate patients who were receiving cataract treatment.

Hospitals in Chicago, Columbia, Mo., and St. Louis, reported to AbTox that their sterilizer was suspected of causing injuries to several patients. The company failed to notify the FDA about these reports as required.

The defendants, the president and vice-president of AbTox, face significant penalties including incarceration, fines, and restitution.

SOURCE:  http://www.fda.gov/bbs/topics/NEWS/2006/NEW01367.html