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Published on: June 5, 2012
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.
Background:
Several outbreaks and pseudo-outbreaks of Pseudomonas aeruginosa and Serratia marcescens infections associated with bronchoscopy have been reported. We conducted an investigation of P. aeruginosa and S. marcescens isolates related to bronchoscopy at a community hospital.
Methods:
We reviewed the records of all bronchoscopic procedures at the community hospital from July to October 2001. Environmental samples were obtained. Pulsed-field gel electrophoresis (PFGE) was performed on isolates of P. aeruginosa.
Results:
From July 1 to October 31, 2001, 66 bronchoscopic procedures were performed in 60 patients, and 43 specimens were obtained for bacterial culture; 20 of the specimens (47 percent) were positive for P. aeruginosa. Six (30 percent) of the specimens that were positive for P. aeruginosa also yielded S. marcescens. All 20 P. aeruginosa isolates were associated with procedures performed with three of four new bronchoscopes from the same manufacturer. Contrary to manufacturing specifications, the biopsy-port caps on all four bronchoscopes were easily removable, and P. aeruginosa was cultured from the biopsy ports of the three implicated bronchoscopes. The PFGE patterns of P. aeruginosa isolates from the bronchoscopes, patients, and two environmental samples were indistinguishable. One patient was hospitalized with P. aeruginosa pneumonia 11 days after bronchoscopy. The manufacturer reported a design change instituted in 1997, and production problems may have resulted in the distribution of bronchoscopes that did not meet specifications.
Conclusions:
We documented contamination of bronchoscopes with P. aeruginosa and S. marcescens and possible infection of patients at a community hospital as a result of the inadequate disinfection of bronchoscopes because of a manufacturing defect.
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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