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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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