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

Charlotte J. Verfaillie; Marco J. Bruno; Anne F. Voor in ’t holt; Jolanda G. Buijs; Jan-Werner Poley; Arjo J. Loeve; Juliette A. Severin; Leo F. Abel; Bert J. Smit; Inge de Goeij; Margreet C. Vos

doi:10.1055/s-0034-1391886

Endoscopy, Table of Contents

Endoscopy 2015; 47(06): 493-502
DOI: 10.1055/s-0034-1391886

Original article

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

Authors

Charlotte J. Verfaillie

¹Department of Clinical Microbiology and Infection Control, AZ Sint-Lucas Ghent, Ghent, Belgium

²Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Marco J. Bruno

³Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Anne F. Voor in ’t holt

²Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Jolanda G. Buijs

⁴Department of Medical devices, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Jan-Werner Poley

³Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Arjo J. Loeve

⁵Department of Biomechanical Engineering, Faculty of Mechanical, Maritime and Materials Engineering, Delft University of Technology, Delft, The Netherlands
Juliette A. Severin

²Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Leo F. Abel

³Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Bert J. Smit

⁶Sector Patient Care, Service Organization Knowledge, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Inge de Goeij

²Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
Margreet C. Vos

²Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands

Abstract

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.

Full Text

References

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