On April 12, FDA made an update to its December 2018 Safety Communication about the results it received from post-market surveillance studies (“522 studies”) on duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography procedures (ERCP). As reports of duodenoscope-related infections declined 62 percent to fewer than 100 in 2017, the agency assumed the studies would yield less than a 0.4 percent contamination rate. According to preliminary results, they saw much higher-than-expected levels of contamination.
3
people died in the United States in 2018 from duodenoscope-related infections.
45
incidents of patient infection related to duodenoscopes were reported last year.
159
device contamination reports were made in 2018.
3.6%
of properly collected samples tested positive for low to moderate concern organisms with >100 CFU.
5.4%
of properly collected samples test positive for high concern organisms, defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa, a 3% increased contamination rate than previously reported.
