Two patient deaths linked to bronchoscopy
Faulty scopes recalled by U.S. manufacturer
A nationwide recall of bronchoscopes is under way because the equipment has a loose port that may act as a reservoir for Pseudomonas aeruginosa infections, the Centers for Disease Control and Prevention (CDC) reports.
Investigators at Johns Hopkins University in Baltimore notified the CDC of Pseudomonas aeruginosa infections and colonizations that may be associated with the defective bronchoscopes. On Nov. 30, 2001, Olympus America Inc. issued a voluntary recall of defective Olympus bronchoscopes with the loose port. The recall involved these models: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, and BF-XT160.
A group of approximately 410 Johns Hopkins patients underwent bronchoalveolar lavage between June 1, 2001, and Feb. 4, 2002. Many of the patients were critically ill at the time of their procedures, all of which took place in the same endoscopy lab in the hospital. Bacterial contamination was confirmed in three of seven bronchoscopes used for examining these patients. In early February, officials at Johns Hopkins became aware of a national recall notice sent out earlier by Olympus to hundreds of hospitals. The notice was prompted by a report from another medical center of bacterial contamination in its bronchoscopes.
In its recall notice, Olympus noted that a loose port on certain bronchoscopes might have permitted the contamination to occur. (See www.olympusamerica.com.) Four of the seven scopes used by Johns Hopkins, including the three in which contamination was found, were subject to this recall. Preliminary findings indicate that about 100 of the approximately 410 patients in the group have tested positive for exposure to pseudomonas, a two- to three-fold greater incidence than expected for this organism in this group of patients.
Infections related to the contaminated scopes may have contributed to the deaths from pneumonia of two already critically ill patients, according to a statement issued by Johns Hopkins.
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