(This story was updated at 3:30 p.m. ET.)
The Food and Drug Administration has cited manufacturers of the medical scopes linked to two separate drug-resistant superbug outbreaks over the past year for a host of violations.
The Food and Drug Administration Monday issued warning letters to all three makers of duodenoscopes – Olympus, Fujufilm, and Hoya Corp. – citing failures in the production of the devices and in their internal processes for handling reports of adverse events.
In the case of Olympus, the dominant manufacturer of duodenscopes, the FDA cited the company for failing to file timely reports on incidents involving 16 patients who contracted Pseudomonas, a common infection occurring with patients in healthcare settings after that have undergone surgery. Olympus did not report the infection cases until three years after it found out in 2012 that those cases were associated with contaminated scopes.
Manufacturers are required to report adverse events involving their devices to the FDA no later than 30 days after they become aware of a possible safety issue.
In the FDA's warning to Fujifilm, the agency cited the company for failing to maintain processes to ensure that design requirements of its devices were met.
Both Fujifilm and Hoya were cited for failing to adequately test cleaning procedures involving their scopes. In the case of Hoya's scopes, the FDA found that studies the company conducted on its disinfection procedures were done on endoscopes that were a different model from the model the agency cited. The FDA said Hoya failed to offer explanation as to why validation results for a different model of scope were applicable for the model in question.
Earlier this month, the FDA issued additional guidance for hospitals to clean duodenoscopes. But the agency acknowledged such measures would be difficult for some providers because of the extras costs and staffing that would be required.
Steps recommended by the FDA in addition to cleaning include using ethylene oxide gas for sterilization and taking microbiological cultures to check for contamination before a scope is reused. Those procedures already are being used at a number of hospitals, including Virginia Mason Medical Center in Seattle. That facility experienced an outbreak of carbapenem-resistant enterobacteriaceae (CRE) involving 32 patients who underwent endoscopic procedures between November 2012 and January 2014.
Leaders at Ronald Reagan UCLA Medical Center, where as many as 179 people were exposed to CRE while undergoing endoscopic procedures between October 2014 and January 2015, said they were going to begin using ethylene oxide sterilization. The officials said the manufacturer-recommended cleaning protocols they had followed were inadequate.
The FDA said it received 75 adverse medical-device reports between January 2013 and December 2014 regarding duodenoscopes with possible transmission of microbial pathogens to approximately 135 patients. It said it had been aware of the potential problem involving the devices for more than a decade.
An agency review of incidents dating back to 1997 found 146 reports of patient infections, exposures or device contaminations associated with the use of duodenoscopes for endoscopic retrograde cholangiopancreatography procedures. Nearly all of those reports came over the past five years.
