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The now-infamous superbug outbreak related to a medical device that seriously sickened 350 people and killed at least 20 illustrates a huge problem in our medical system: poor monitoring of the safety of medical devices.

The episode in question lasted several years and involved a widely used duodenoscope, a flexible tube inserted in the mouth in order to reach the small intestine, made by Olympus. It began in January 2012 when Erasmus Medical Center in the Netherlands experienced an outbreak of a multidrug-resistant infection among 30 of its patients. An investigation linked the outbreak to the use of a specific Olympus duodenoscope, whose design flaws made it impossible to completely disinfect the device.

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