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This paper describes the investigation of an unexpected rise in the number of bronchoscopic cultures growing Pseudomonas and Serratia spp in a community hospital. Over a 4 month period 20 of 43 samples tested positive for one or both organisms. All 20 positive cultures were from procedures performed using newly purchased bronchoscopes. Identical organisms were isolated from the biopsy port of the new bronchoscopes and the sink trap in the endoscopy unit. One patient was readmitted with Pseudomonas pneumonia. During the same period there were no positive samples from older bronchoscopes used in the department. The biopsy port cap was found to be loose on all four new bronchoscopes. The manufacturer subsequently recalled approximately 14 000 bronchoscopes worldwide for modification. New devices are less likely than drugs to have their safety established clinically before they are marketed. Effective surveillance of marketed medical devices could identify low frequency adverse events including those due to changes in design or manufacture and those resulting from interactions between devices or operators.
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