The number of patients sickened by endoscopes carrying carbapenem-resistant Enterobacteriaceae (CRE) between 2010 and 2015 is much higher than the Food and Drug Administration previously reported, according to the results of a Congressional investigation obtained by Kaiser Health News.
Congressional investigators led by Rep. Ted Lieu (D-Calif.) found a link between tainted scopes and the cases of some 350 patients at 41 providers worldwide. The House Committee on Oversight and Government Reform said that it has evidence that contaminated duodenoscopes were responsible for:
Up to 404 patient infections
Forty-four additional patient exposures to contaminated devices
Incidents at 41 facilities in the U.S. and abroad
Thirty-four incidents in which patients were infected or exposed to contaminated devices
More than 300 Medical Device Reports on patient infections, exposure and device contamination
The full report is expected to be released on Friday, according to Kaiser Health News.
By law, the committee is not allowed to name the facilities where the infections took place. The House investigation uncovered several legislative gaps that allowed the outbreak to progress unchecked and for the defective scopes, all manufactured by Tokyo-based Olympus Corp., to remain on the market.
Olympus Corp., investigators said, knew the scopes were defective but waited to inform U.S. regulators and even hiked their prices during the outbreak in order to maximize profits.