Endoscopy 2015; 47(06): 493-502
DOI: 10.1055/s-0034-1391886
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa

Charlotte J. Verfaillie
1   Department of Clinical Microbiology and Infection Control, AZ Sint-Lucas Ghent, Ghent, Belgium
2   Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Marco J. Bruno
3   Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Anne F. Voor in ’t holt
2   Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Jolanda G. Buijs
4   Department of Medical devices, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Jan-Werner Poley
3   Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Arjo J. Loeve
5   Department of Biomechanical Engineering, Faculty of Mechanical, Maritime and Materials Engineering, Delft University of Technology, Delft, The Netherlands
,
Juliette A. Severin
2   Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Leo F. Abel
3   Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Bert J. Smit
6   Sector Patient Care, Service Organization Knowledge, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Inge de Goeij
2   Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
,
Margreet C. Vos
2   Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
› Author Affiliations
Further Information

Publication History

submitted17 December 2014

accepted after revision02 March 2015

Publication Date:
31 March 2015 (online)

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See also:

Endoscopy-associated transmission of carbapenemase-producing Enterobacteriaceae: return of 5 years’ experienceEndoscopy 2015; 47(06): 561-561
DOI: 10.1055/s-0034-1392098

See also:

Commentaire du travail de Verfaillie CJ et al., pp. 493Endoscopy 2015; 47(06): 570-570
DOI: 10.1055/s-0035-1547093

See also:

Video Comment on Verfaillie CJ et al.Endoscopy 2015; 47(06): v9-v9
DOI: 10.1055/s-0034-1392264

Corrected by:

Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosaEndoscopy 2015; 47(06): 502-502
DOI: 10.1055/s-0034-1392080

Background and study aims: Infections are a recognized risk of endoscopic retrograde cholangiopancreatography (ERCP). This paper reports on a large outbreak of VIM-2-producing Pseudomonas aeruginosa that was linked to the use of a recently introduced duodenoscope with a specific modified design (Olympus TJF-Q180V).

Methods: Epidemiological investigations and molecular typing were executed in order to identify the source of the outbreak. Audits on implementation of infection control measures were performed. Additional infection control strategies were implemented to prevent further transmission. The design and the ability to clean and disinfect the duodenoscope were evaluated, and the distal tip was dismantled.

Results: From January to April 2012, 30 patients with a VIM-2-positive P. aeruginosa were identified, of whom 22 had undergone an ERCP using a specific duodenoscope, the TJF-Q180V. This was a significant increase compared with the hospital-wide baseline level of 2 – 3 cases per month. Clonal relatedness of the VIM-2 P. aeruginosa was confirmed for all 22 cases and for the VIM-2 strain isolated from the recess under the forceps elevator of the duodenoscope. An investigational study of the new modified design, including the dismantling of the duodenoscope tip, revealed that the fixed distal cap hampered cleaning and disinfection, and that the O-ring might not seal the forceps elevator axis sufficiently. The high monthly number of cases decreased below the pre-existing baseline level following withdrawal of the TJF-Q180V device from clinical use.

Conclusions: Duodenoscope design modifications may compromise microbiological safety as illustrated by this outbreak. Extensive pre-marketing validation of the reprocessability of any new endoscope design and stringent post-marketing surveillance are therefore mandatory.