In 2012, Olympus warned European hospitals that one of its medical scopes was harboring dangerous bacteria. More than two years later, U.S. hospitals reported infectious outbreaks linked to the same scope that ultimate infected more than 250 people between 2012 and 2015. The patient safety debacle left many wondering how this could happen. A massive kickback scheme that predated the outbreak offers some belated clues, revealing an eroded corporate culture that valued profits over compliance, regardless of the repercussions.
The nation's largest distributor of endoscopes has agreed to pay $646 million to settle criminal and civil claims that the company offered various kickbacks to hospitals and doctors that signed deals to purchase medical equipment, according to the Department of Justice.
The Food and Drug Administration has cleared Olympus' modified design and labeling of its TJF-Q180V duodenoscope that was linked to a superbug outbreak.
The dirty duodenoscope scandal is ugly and troubling, and there is a lot of blame to go around.
The Food and Drug Administration has sent warning letters to three major manufacturers of a specialized medical scope linked to deadly "superbug" outbreaks at hospitals.
An advisory panel convened by the Food and Drug Administration urged the agency to better protect patients from specialized medical scopes linked to recent superbug outbreaks, the L.A. Times reports.