The 25 cases are more than originally reported, and resulted from numerous flaws in the federal government’s oversight of medical devices, which are continuing to put patients at risk “with life-threatening consequences,” the investigators stated.
Sen. Patty Murray (D-Wash.), who initiated the probe after dozens of patients were sickened at a Seattle hospital, stated “Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”
According the LA Times, the report provides details showing that Olympus Corp, the leading manufacturer of duodenoscopes, was aware of the potential flaws in the scope as early as Spring 2002, resulting from an independent investigation done in the Netherlands following an outbreak there.
READ MORE Duodenoscope LEGAL NEWS
On February 19, 2015, the FDA warned that the complex design of ERCP endoscopes may prevent them from being properly sanitized, even when manufacturer recommended sanitation guidelines are followed.
"Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the FDA warned.
The agency noted that from January 2013 to December 2014 it received 75 medical device reports involving around 135 patients who suffered a possible microbial transmission from duodenoscopes. The FDA said it will continue to monitor the association between duodenoscopes and infectious agents.