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Is the duodenoscope designed to cause infection?

With the rise of the so-called "superbug," there is a curious development. Going to a doctor or hospital may expose a patient to an illness more dangerous than the one that caused their visit in the first place. The illness is caused by bacteria that are known as carbapenem-resistant Enterobacteriaceae (CRE), and are extremely resistant to treatment by antibiotics.

The troubling element of this developing story is that some tools or instruments used in hospitals and doctors' offices may be in essence, designed to harbor bacteria, even after following the manufacturers recommended decontamination procedures, and that some doctors may have been aware of this danger more than 25 years ago.

One doctor reports he was able to link an outbreak of bacterial infection in 10 patients to use of a duodenoscope in his office. This instrument, used to examine a patients intestinal tract. The year was 1987, and other doctors have stated that they have known for years of the potential for this instrument to transfer infection.

A duodenoscope has been determined to be the cause of infections that have killed patients and may have exposed as many as 179 in the UCLA medical center. This week, for the first time, the he Food and Drug Administration has issued instructions to hospitals recommending hand cleaning of parts of a duodenoscope.

From a product liability perspective, it is unclear how manufacturers could have remained ignorant of the risks of infection and why they have failed to make design changes that would either prevent the device from harboring deadly bacteria or to issue cleaning protocols that would ensure it could not spread bacteria.

Perhaps the lawsuits that will ensue will enlighten us.

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