Even more infections linked to dirty duodenoscopes than previously feared
Last year was a bad year to be a duodenoscope manufacturer. In February 2015, the Food and Drug Administration (FDA) issued a safety communication for all endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes. The communication warned hospitals that even if they followed proper disinfection procedures, the design of the scopes could prevent them from being properly sterilized.
This was followed by a recall of Custom Ultrasonic reprocessors, a wrongful death lawsuit against Olympus Corp. (which owns 85% of the U.S. duodenoscope market), and a damning report showing that Olympus knew about its devices’ infection risks for nearly three years without warning people. Then in December, the FDA linked 45 antibiotic-resistant infections (ARI) cases since 2012 to Olympus duodenoscopes, with 24 resulting illnesses and 21 deaths.
Now a new Senate committee report has tripled the number of confirmed Olympus scope infections to 142. Industrywide, 250 patients have contracted ARIs from duodenoscopes, with 25 infection outbreaks in 10 states and four countries since 2012. Several of the outbreaks involved Carbapenem-resistant Enterobacteriaceae infections, which can kill up to 50% of those it infects and can sometimes share its drug resistance with other bacteria.
The three companies singled out in the report were Pentax Medical, Fujifilm Medical Systems, and Olympus Corp. The Senate Health, Education, Labor, and Pensions Committee also placed blame on the FDA, saying their safety reporting system was too slow and cumbersome. Potentially due to the duodenoscope issue, the FDA had recently changed its reporting procedures to allow for quicker warnings to consumers.