Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy

Table 4 Several reports of outbreaks of carbapenem-resistant Enterobacteriaceae (or a related superbug) following gastrointestinal endoscopy that were filed in the Food and Drug Administration’s MAUDE database between 2012 and 2014 by manufacturers of gastrointestinal endoscopes and related medical equipment

Reports filed in 2014:

(1) Food and Drug Administration. Report date: May 2, 2014. Report number: 2951238-2014-00225. (Infections or colonizations of patients following ERCP with an extended β-lactamase [ESBL] strain of E. coli strain. Also refer to Report number: 2951238-2014-00004)

(2) Food and Drug Administration. Report date: March 7, 2014. Report number: 2518897-2014-00001[36]. (Infections or colonizations of patients following ERCP with CRE)

(3) Food and Drug Administration. Report date: January, 28, 2014. Report number: 2951238-2014-00027[38]. (Infections or colonizations of patients following ERCP with CRE)

(4) Food and Drug Administration. Report date: January 16, 2014. Report number: MW5033987[39]. (Infections or colonizations of patients following ERCP with CRE)

(5) Food and Drug Administration. Report date: May 27, 2014. Report number: MW5036408. (One patient infected or colonized with CRE following ERCP)

Reports filed in 2013:

(1) Food and Drug Administration. Report date: March 4, 2013. Report number: MW5029305[37]. (Infections or colonizations of patients following ERCP with CRE)

(2) Food and Drug Administration. Report date: September 30, 2013, and October 28, 2013. Report number: 2518897-2013-00005. (Also refer to Report number: 2523209-2013-00013). Note: This report was presumably filed by Hospital X documenting its CRE outbreak identified between January and September, 2013

Reports filed in 2012:

(1) Food and Drug Administration. Report date: September 25, 2012. Report number: 8010047-2012-00404. (Infections or colonizations of patients following ERCP with a multidrug-resistant E. coli)

(2) Food and Drug Administration. Report date: November 21, 2012. Report number: 8010047-2012-00454. (Possible infections or colonizations of patients following ERCP with E. coli; the bacterial strain is not necessarily resistant to antibiotics; and this incident may be a pseudo-outbreak, not true infections or colonizations)

These reports, which do not identify the medical facility by name, associate a contaminated ERCP endoscope with a confirmed patient infection or colonization, or with an outbreak of CRE or a related superbug. (Some of these reports are included in this article’s reference section. This table's listed reports for each year may not be inclusive of every report filed in that year). CRE: Carbapenem-resistant Enterobacteriaceae; GI: Gastrointestinal.