title: Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa.
abstract: OBJECTIVE
  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.
authors.affiliation: 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
authors.forename: Charlotte J
authors.initials: CJ
authors.lastname: Verfaillie
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Marco J
authors.initials: MJ
authors.lastname: Bruno
authors.affiliation: Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Anne F
authors.initials: AF
authors.lastname: Voor in 't Holt
authors.affiliation: Department of Medical devices, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Jolanda G
authors.initials: JG
authors.lastname: Buijs
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Jan-Werner
authors.initials: JW
authors.lastname: Poley
authors.affiliation: Department of Biomechanical Engineering, Faculty of Mechanical, Maritime and Materials Engineering, Delft University of Technology, Delft, The Netherlands.
authors.forename: Arjo J
authors.initials: AJ
authors.lastname: Loeve
authors.affiliation: Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Juliette A
authors.initials: JA
authors.lastname: Severin
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Leo F
authors.initials: LF
authors.lastname: Abel
authors.affiliation: Sector Patient Care, Service Organization Knowledge, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Bert J
authors.initials: BJ
authors.lastname: Smit
authors.affiliation: Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Inge
authors.initials: I
authors.lastname: de Goeij
authors.affiliation: Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
authors.forename: Margreet C
authors.initials: MC
authors.lastname: Vos
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation*; D003428:Cross Infection / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D004196:Disease Outbreaks / Q000517:prevention & control*; D020698:Duodenoscopes / Q000382:microbiology*; D004867:Equipment Design; D006801:Humans; D017053:Infection Control / Q000379:methods*; D009426:Netherlands; D011552:Pseudomonas Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D011550:Pseudomonas aeruginosa / Q000302:isolation & purification* / Q000378:metabolism; D012189:Retrospective Studies; D062606:Tertiary Care Centers; D001618:beta-Lactamases / Q000378:metabolism
chemical_list: D015415:Biomarkers; C425108:beta-lactamase bla(vim-2); D001618:beta-Lactamases