Pseudomonas aeruginosa and Serratia marcescens contamination associated with a manufacturing defect in bronchoscopes
- PMID: 12529461
- DOI: 10.1056/NEJMoa021791
Pseudomonas aeruginosa and Serratia marcescens contamination associated with a manufacturing defect in bronchoscopes
Abstract
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.
Copyright 2003 Massachusetts Medical Society
Comment in
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Ensuring safe and effective medical devices.N Engl J Med. 2003 Jan 16;348(3):191-2. doi: 10.1056/NEJMp020170. N Engl J Med. 2003. PMID: 12529457 No abstract available.
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Outbreaks of infection associated with bronchoscopes.N Engl J Med. 2003 May 15;348(20):2039-40; author reply 2039-40. doi: 10.1056/NEJM200305153482021. N Engl J Med. 2003. PMID: 12748325 No abstract available.
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