FDA reveals duodenoscope procedures likely infected far more than initially reported
Ahead of next week’s advisory panel convening, the FDA released some eye opening details related to the superbug outbreaks linked to dirty duodenoscopes. Reports of these outbreaks occurred at hospitals across the country, including Virginia Mason Medical Center in Seattle, WA
Federal regulators disclosed additional clues about the potential harm to patients from a controversial medical scope, providing 142 reports of contaminated devices and possible patient infections since 2010. This came out via a May 7, 2015 LA Times article.
The Food and Drug Administration (FDA) had previously said it received about half that many reports, 75, on duodenoscopes that caused patient infections in 2013 and 2014.
The number of patients involved could be far higher than 142 given that one adverse event report may include many individual procedures/people.
The FDA panel of medical experts is expected to recommend additional steps to regulators, device manufacturers and hospitals. These are steps needed to protect patients undergoing a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP.
Officials report that 669,000 ERCP procedures were performed last year on patients battling cancer, gallstones and other digestive issues.
As we have seen in the news, advocates and lawmakers are directing harsh criticism at the FDA and Olympus Corp., maker of duodenoscopes. Why did they not sooner and more emphatically to report these hospital outbreaks? This would have alerted the broader medical community about the risks of the scope procedure.
Investigations have revealed that patients were infected even when medical centers followed the manufacturers’ (Olympus, Pentax Medical, and Fujifilm) cleaning instructions. Health officials learned that deadly bacteria are easily trapped at the tip of these duodenoscopes.
“The transmission of infectious material from patient to patient during ERCP, although uncommon, represents a serious public health concern,” the FDA states in its latest report.
Federal officials acknowledged that their surveillance system for medical devices has limitations and that incidents can be underreported by manufacturers.