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Old Kidney Machines Caused Deaths

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All of the suspect kidney filters were thrown out and burned before CDC investigator Matthew J. Kuehnert, MD, arrived on the scene. However, by finding and then testing many old dialyzers of many different types, the investigators were able to determine that under certain conditions, old filters sometimes gave off toxic chemicals. These toxic chemicals caused eye problems in laboratory animals that were very much like the symptoms seen in the seven patients.

"This was a very unusual event that hasn't been reported before or since," Kuehnert, co-author of the report, tells WebMD. "This is a unique syndrome constellation of very severe symptoms that resulted in permanent disability in many of these patients due to a substance from aged dialyzers. FDA and CDC have issued recommendations to prevent this sort of unusual event from happening again, and that includes rotating dialyzer stock and having dates on them. For the future, it is important to have surveillance in place so if events occur or if there is a cluster of events, that is picked up."

Whether this actually was the first time this event happened is a matter of some dispute. According to a report by writer Shawn Windsor in the Huntsville Times, a lawyer representing the injured patients charged in court papers that a similar event occurred in Japan several years before the 1996 outbreak. The attorney claimed that this event was brought to the attention of the product manufacturer and that the manufacturer failed to act. The manufacturer strenuously denied these allegations. The case eventually was settled out of court. Hutter and colleagues say the Japanese incident was caused by different toxins released by a different chemical process than that which occurred in the U.S. case.

Hutter says no one is to blame. "It was unfortunate. It could have happened to anybody at any hospital with the technology available at the time -- anybody who happened to have bad luck with the fibers from the factory with the bad conditions and the long storage time as well."

Some quarter of a million U.S. patients currently are undergoing this process, called hemodialysis. CDC surveillance shows that 43% of the centers at which they are treated use dialyzers with the same type of membrane used by the case patients. These dialyzers actually have a very good safety record, Hutter says. An additional 14% of centers use similar filters. Ironically, a recent study shows that products treated with the chemicals that broke down in the Alabama hospital are safer than untreated products.

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