Six cases outside of the USA associating exposure to a duodenoscope with infections or an outbreak of CRE or a related MDRO (listed in chronological order)
| Case number | Approximate year infections, outbreak began | Reference number | Medical facility's country | Type of resistant bacteria (eg, CRE) | Number of patients infected (or testing positive) | Number of patients who expired* | Sealed or unsealed duodenoscope model? | Were bacteria† recovered from a duodenoscope? | Was HLD being performed? | Was duodenoscope reportedly reprocessed according to manufacturer IFUs? | Case's possible cause(s) | Case's implemented measure(s), response |
| 1 | 2012 | 7 11 22 | The Netherlands | MDRO (VIM-2-producing Pseudomonas aeruginosa) | 22 | NR | Sealed | Yes | Yes | Yes | The duodenoscope's design, which includes a fixed distal cap and an o-ring intended to seal the elevator-wire channel, was reported. | Implicated duodenoscope model was removed from use. |
| 2 | 2012 | 7 | France | Possibly CRE (E. coli) | 3 | NR | Sealed | No | NR | NR | Not determined. | NR |
| 3 | 2012 | 53 | Germany | CRE (carbapenem-resistant OXA-48-producing Klebsiella pneumoniae) | 6 | NR | Sealed | No | Yes | Yes | Inadequate duodenoscope reprocessing reported ("most probably" due to the physical design of the duodenoscope's distal end). | The implicated duodenoscope was sent to the manufacturer for maintenance, which revealed some "defects." |
| 4 | 2013 | 7 | France | Likely MDROs (Enterobacteriaceae, Pseudomonas spp.) | 2 | NR | Sealed | Yes | NR | No | Not determined. | NR |
| 5 | 2014 | 7 | Germany | CRE (K. pneumoniae) | 4 | NR | Sealed | Yes | NR | NR | Not determined. | NR |
| 6 | 2018 | 54 | Country unknown (outside of USA) | CRE or MDRO ("klebsiela pseudomonas producer of carbapenemasa") [sic] | 3 | NR | Unsealed | Yes | Yes | No | NR | NR |
Note: This list is not inclusive of all cases since 2012.
*The infections were not necessarily the cause of the deaths and could have been due to other underlying medical problems (eg, cancer, liver failure).
†The bacteria collected from the tested duodenoscope may be, but are not necessarily, the outbreak’s strain.
CRE, carbapenem-resistant Enterobacteriaceae; EO, ethylene oxide; HLD, high-level disinfection; IFUs, instructions for use; MDRO, multidrug-resistant organism; NR, not reported.