Olympus Q180V ERCP Duodenoscope

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Duodenoscopes are flexible tubes that are sent through the mouth, throat, and stomach to access the top of the small intestine. The scopes are traditionally used during a procedure to diagnose and treat pancreas and bile duct issues called endoscopic retrograde cholangiopancreatography (ERCP).Olympus Corp. manufactures the vast majority of ERCP scopes used in the United States.

However, in 2013, the Centers for Disease Control and Prevention (CDC) alerted the Food and Drug Administration (FDA) about a link between these scopes and a multi-drug resistant bacteria. The FDA has opened an ongoing investigation into duodenoscopes and their link to life-threatening infections caused by the bacteria.

What is Carbapenem-resistant Enterobacteriaceae (CRE)?

Carbapenem-Resistant Enterobacteriaceae (CRE) is an antibiotic-resistant bacteria that is most often observed in patients with compromised immune systems. These infections typically occur in patients in hospitals, nursing homes, and other healthcare settings. Ventilators, catheters, and long courses of certain antibiotic medications can increase the risk of developing CRE. Unfortunately, CRE infections are extremely deadly. Due to their difficult nature to treat, CRE infections contribute to death in 50 percent of patients that contract the infection.

The FDA issued a safety communication regarding cleaning and disinfecting instructions for reusable duodenoscopes.

Modified Olympus Duodenoscope Linked to Same Deadly Bacteria

According to a report filed by the FDA, five patients in a foreign medical facility underwent procedures with a duodenoscope and contracted the same deadly bacteria that had infected hospitals in the United States. However, the duodenoscope used in this case was Olympus’ remodel of their original Q180V scope. In January 2016, Olympus issued a recall on the current model, stating that a new model with a more easily cleanable mechanism would be replacing them. Alongside the new model would be new cleaning procedures as well.

Olympus attempted to correct the mechanism previously in 2010, but investigations revealed that biological material and bacteria could still enter the internal channel of the scope and remain present thereafter following the prescribed cleaning instructions.

According to the Los Angeles Times, Olympus knew of potential flaws after an outbreak occurred in the Netherlands. In addition, the Japan-based company did not alert American hospitals or the FDA regarding the potential design flaws of their endoscopic retrograde cholangiopancreatography scope until after the Southern California CRE outbreaks.

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