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reusable medical devices, Chicago medical malpractice lawyerReusable medical devices, like the duodenoscope, have led to deaths due to not being able to sterilize them sufficiently. Why does it take so long to update sterilization standards for reusable medical devices? This is a cause for concern, but the new standards are not required to be used on existing products on the market, even though that is where the concern and problems began. The Food and Drug Administration (FDA) is only requiring new products to adhere to new rules, stricter guidelines, and more testing.

Multiple deaths and infections, starting as early as 2012, have been linked to a deadly bacterial infection caused by a deodenoscope that was not completely sterilized because of the small crevices in the scope and the internal tubing. A duodenoscope is a device that is used to diagnose and treat diseases in the liver, gallbladder, and pancreas. It is inserted through a patient’s throat while they are being given general anesthesia and it continues down through the stomach to the point where the stomach and small intestines meet.

Due to the recent death of two people in a Los Angeles hospital being linked to contracting this deadly bacterium through reusable devices, the FDA is asking manufacturers to prove their products can be sterilized, including the small crevices where bacteria can live. Since the FDA is only requiring new market products to be held to higher standards though, it may take a while before they are practiced with current products in the market. This can lead to more deaths or injuries to patients.

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superbug product liability, Chicago personal injury lawyerIn 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.

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