Monday, December 21, 2015

How a medical device maker kept U.S. hospitals in the dark about deadly infections - Los Angeles Times

A 2012 inspection by Olympus and Dutch hospital
officials revealed a brown film inside a duodenoscope.
(Arjo Loeve / Delft University of Technology)
How a medical device maker kept U.S. hospitals in the dark about deadly infections - Los Angeles Times
Over the next three years, 21 people died and at least two dozen more became ill from infections related to scopes in Pittsburgh, Seattle and Los Angeles. An unknown number of other patients have been infected. The Food and Drug Administration has identified 10 outbreaks, seven of which involve Olympus scopes.
Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections, according to interviews with dozens of hospital officials, doctors, regulators and former Olympus employees.
In February 2015, immediately after the UCLA outbreak was reported, Olympus sent an alert to customers. It disclosed, for the first time, that it was aware of 95 complaints tying its scope to patient infections.

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