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Superbug outbreaks related to duodenoscopes : hospital negligence or product liability ? And what is the FDA doing about it?

Since 2009, the FDA has been aware that duodenoscopes manufactured by Japanese companies Olympus, Pentax and Fujifilm have been at the origin of the spread of sometimes fatal spread of pathogens but did nothing to change the situation. Hospitals that faced such outbreaks began sterilizing the devices more rigorously and the transmission of dangerous disease stopped. Therefore, the suspicion was that the superbug outbreak happened because of medical malpractice during which the hospital staff didn’t respect the sterilization procedure. However for the first time on Thursday the FDA said that even hospitals that fully respected the sterilization process could have their devices infected by the superbug. However the FDA didn’t propose to improve the sterilization procedures. They only issued a “safety communication” warning healthcare providers that duodenoscopes’ “complex design” may impede effective sterilization.  The problematic part is a movable “elevator” mechanism at the tip of the duodenoscope: Its moving parts have microscopic crevices where bodily fluids can remain after standard cleaning.  The FDA and the manufacturers are aware of this deadly manufacturing flaw but the FDA didn’t require the manufacturers to improve their device either. Read more on Reuters