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FDA Refuses to Pull Endoscopy Devices Linked to CRE Superbug

March 12, 2015  ·  By HM&M

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In the last several months, two hospitals in California have reported outbreaks of what officials are referring to as the CRE superbug. At Ronald Reagan UCLA Medical Center in Los Angeles, two patients died after being infected and five others continue to receive treatment. Medical officials have reached out to nearly 180 additional patients who may have been exposed at the facility. The outbreak has been traced to a particular medical device, which federal regulators are, so far, reluctant to pull from the market.

Carbapanem-resistant enterobacteriaceae, or CRE, is a bacterial pathogen which can cause infections resistant to most antibiotic treatment. Certain bacteria, such as E. coli, which are common to the human digestive system, can evolve and become carbapanem-resistant, resulting in strains of CRE potentially producing infections that are very difficult to treat. The Centers for Disease Control and Prevention (CDC) acknowledges the dangers inherent to CRE infections and has reported that the superbug may be fatal in up to 50 percent of infected patients.

Each of the infected UCLA patients had undergone a relatively minor endoscopic procedure utilizing a device known as a duodenoscope. More than half a million patients each year have similar procedures done with the device, which is an imaging tool used to detect and diagnose issues in the upper small intestines, gall bladder, and pancreas. A particular duodensoscope at UCLA, however, was found to be the source of the CRE exposure, according hospital officials. A subsequent CRE outbreak at Cedars-Sinai Medical Center, also in Los Angeles, is currently being investigated to confirm that a similar device was to blame.

UCLA officials have determined that the manufacturer’s sterilizing protocols had been followed by hospital staff with the duodenosocope in question, and that the issue lies with the model’s design flaws. The United States Food and Drug Administration (FDA) maintains that the evidence is not clear that a particular model is to blame and that infected patients have used duodenscopes from a variety of manufacturers.

The FDA does acknowledge, however, that the device at UCLA is a model which has yet to receive the administration’s approval. “[The manufacturer] has a pending 510(k) application for this device, and the company continues to market the product while the application is under review,” the FDA said in a published report. The report went on to say that the FDA would not recommend removing the device from the market due to clinical demand.

While government regulators seem to have no issue allowing a potentially dangerous medical device continuing to be sold and used, patients should not have to fear minor gastrointestinal procedures. Keeping a flawed product in service to meet clinical demands can potentially result in the infection of dozens, if not hundreds, of additional patients. Potential health hazards cannot be overlooked, particularly if the equipment has yet to receive FDA approval, and doing so may lead to significant liability on the part of the manufacturer.

Medical device manufacturers should be held accountable for the designs of their products, especially when they directly impact the health and safety of patients. If you or someone you love has been affected by any type of hospital related infection, and a defective product design may be to blame, contact an experienced Chicago product liability attorney. Call to schedule your free consultation today.

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