A Deadly Design

A superbug outbreak that killed 20 people and seriously sickened 350 is being blamed on defects in the Olympus duodenoscope, a flexible tube used to reach the small intestine through the mouth.
Despite knowing the device was impossible to completely disinfect, Olympus never warned US health facilities or the FDA. When problems arose, the FDA didn’t get involved for over a year. Experts say the FDA’s limited post-market surveillance and passive safety reporting played a part in the disastrous outcome.
Though tighter legislation could help, electronic surveillance by the FDA is essential, writes Massachusetts General Hospital’s Diana Alame.
Source: STAT

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