Table 2.

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.