Pseudomonas aeruginosa and Serratia marcescens contamination associated with a manufacturing defect in bronchoscopes

David L Kirschke1, Timothy F Jones, Allen S Craig

  • 1Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, USA.

Abstract

Insights

Manufacturing defects in bronchoscopes led to Pseudomonas aeruginosa and Serratia marcescens contamination, causing patient infections. Inadequate disinfection due to design flaws was identified as the root cause in this community hospital investigation.

Area of Science:

  • Medical Microbiology
  • Infectious Disease Epidemiology
  • Medical Device Safety

Background:

  • Bronchoscopy procedures have been linked to outbreaks of Pseudomonas aeruginosa and Serratia marcescens infections.
  • This study investigated P. aeruginosa and S. marcescens isolates associated with bronchoscopy at a community hospital.

Purpose of the Study:

  • To investigate the source and extent of P. aeruginosa and S. marcescens contamination linked to bronchoscopy procedures.
  • To identify potential patient infections resulting from contaminated bronchoscopes.

Main Methods:

  • Retrospective review of bronchoscopic procedures and patient records (July-October 2001).
  • Collection and bacterial culture of environmental samples.
  • Pulsed-field gel electrophoresis (PFGE) for P. aeruginosa isolate typing.

Main Results:

  • 47% of specimens from 66 procedures were positive for P. aeruginosa; 30% of these also yielded S. marcescens.
  • Contamination was linked to three of four new bronchoscopes with easily removable biopsy-port caps, contrary to specifications.
  • PFGE confirmed indistinguishable P. aeruginosa strains from bronchoscopes, patients, and environmental samples, including one case of pneumonia.

Conclusions:

  • Bronchoscopes were contaminated with P. aeruginosa and S. marcescens due to a manufacturing defect.
  • Inadequate disinfection, caused by a design flaw in the biopsy-port caps, likely led to patient infections.
  • The findings highlight the importance of medical device manufacturing quality control and proper disinfection protocols.

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