The number of infections from contaminated duodenoscopes is much higher than previously reported, according to a congressional investigation.
The FDA recently revealed after a yearlong investigation that as many as 350 patients at 41 facilities in the United States and overseas have been infected by tainted scopes between Jan. 1, 2010, and Oct. 31, 2015.
“It’s really disturbing that the number of patients harmed and the number of facilities where this happened keeps rising,” Lisa McGiffert, director of the Safe Patient Project at Consumers Union, told the Los Angeles Times. “It probably indicates the number will continue to increase as authorities dig deeper.”
Olympus America Inc.’s TJF-Q180V duodenoscope was linked to an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) at Ronald Reagan UCLA Medical Center between October 2014 and January 2015, in which two patients died and 200 others were potentially infected. In March 2015, four patients were reportedly infected with CRE and 67 others were potentially exposed at nearby Cedars-Sinai Medical Center.
A senate report from January 2016 found 250 scope-related infections at 25 hospitals worldwide from 2012 to 2015. It also found that Olympus and Fujifilm, another scope manufacturer, never applied for FDA clearance for the new design that was issued for the closed-channel scope.
The manufacturers “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues,” the report said.
Rep. Ted W. Lieu (D-Calif.) has introduced two new bills that would require device manufacturers to notify the FDA about new changes in cleaning instructions or design.
“I was surprised at how much larger the number of infections was and it made me even more upset about the harm these device manufacturers have caused,” Mr. Lieu told the Los Angeles Times. “There are current gaps in the law we need to close to make sure these situations don’t happen again.”