Left To Its Own Devices? Olympus Recall Pushed Into Spotlight
This article was originally published in The Gray Sheet
Executive Summary
Olympus America is conducting a telephone campaign to aid the Melville, New York company's recall of 15 models of its bronchoscopes that contain a design flaw
You may also be interested in...
Bronchoscope safety
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)...
Bronchoscope safety
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)...
Bronchoscope Safety Feature Rides Consumer Awareness Of Olympus Recall
Vision-Sciences, Inc. will emphasize the safety aspects of its EndoSheath bronchoscope system at the World Congress of Bronchology meeting in Boston June 17-18 in preparation for a full-scale launch in July