Bronchoscope safety
This article was originally published in The Gray Sheet
Executive Summary
Outbreak of P. aeruginosa infections in 2001-2002 apparently was caused by loose bronchoscope biopsy-port caps, according to a study by David Kirschke, MD, CDC, et al., published in the Jan. 16 New England Journal of Medicine. A federal mandate that recall notices be sent to all physicians who may use the device could have shortened the outbreak, Kirschke notes, concluding that "instrument safety and surveillance methods for bronchoscopy must be improved." In an editorial, CDRH Director David Feigal counters that FDA's MeDSuN surveillance program helps health care facilities minimize the risk of device-related injuries, offering that the system's first 224 reports, 205 of which were voluntary, included two deaths and 17 serious injuries. Both FDA and bronchoscope manufacturer Olympus America came under fire for late reporting of the original infections (1"The Gray Sheet" March 11, 2002, p. 24)...