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FDA issues safety alert related to hospital disease outbreak

The U.S. Food and Drug Administration has issued a safety alert concerning the use and cleaning of endoscopes in hospitals. The alert follows the deaths of two people who contracted a deadly, antibiotic-resistant bacterial infection, "Carbapenem-Resistant Enterobacteriaceae bacteria.

The first known case of this "superbug" infection in the United States occurred in 1996, and has spread to most states, including South Carolina, since 2006. It is most commonly being found in hospitals. One way that the infection can enter the body is via contaminated medical devices, such as the duodenoscopes subject to the FDA's safety alert.

Of interest in the latest outbreak of CRE is that personnel at the affected hospital had apparently been cleaning the duodenoscopes according to the manufacturer's instructions, but that evidently did not sufficiently decontaminate the equipment. In addition to the two deaths, more than 170 other patients at the latest hospital to be affected were also possibly infected.

From a patient's perspective, or in the worst case from the point of view of surviving loved ones of a patient who dies from an infection like CRE contracted at a hospital, the question of potential liability for the harm suffered may require a thorough analysis of how the harm occurred.

Hospital personnel who were properly following cleaning and maintenance instructions will certainly use that compliance as a defense to negligence claims, as will the hospital that uses the equipment, but such claims must be verified to be accurate.

In addition, the possibility that the manufacturer of the equipment may be liable in a related sense, such as a product liability claim, is another avenue that personal injury attorneys may assist victims and their surviving relatives to explore.

Source: Los Angeles Daily News, “Safety alert issued on device that may have infected nearly 200 UCLA patients,” Susan Abram, Feb. 19, 2015

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