Novel flexible bronchoscope and single-use disposable-sheath endoscope system. A preliminary technology evaluation.
OBJECTIVE
To measure image clarity, ease of use, and handling performance of a flexible fiberoptic bronchoscope (B-F 100; Vision Sciences; Natick, MA) and sterile single-use disposable-sheath endoscope system (BS-F21 EndoSheath; Vision Sciences).


METHODS
Prospective, multicenter diagnostic technology evaluation of a medical device newly approved by the US Food and Drug Administration.


METHODS
Three tertiary care referral centers with busy bronchoscopy practices.


METHODS
Twenty-four patients undergoing bronchoscopy with a flexible fiberoptic bronchoscope and disposable sheath endoscope system.


METHODS
Flexible bronchoscopy was performed through a transnasal or transoral route after topical upper airway anesthesia using standard techniques. After each procedure, the bronchoscopist rated the performance of the medical device under study using a linear scale of 1 (poor) to 5 (excellent and equal to that of a conventional flexible fiberoptic bronchoscope).


RESULTS
Mean performance ratings were > 4.0 (range, 4.17 to 4.63) for image clarity, illumination, lack of fogging, distal tip angulation, and ease of transnasal passage. All other ratings were > 3.0 (range, 3.54 to 3.87), the lowest of which was handling comfort.


CONCLUSIONS
The flexible fiberoptic bronchoscope with sterile single-use disposable-sheath endoscope system has the potential to reduce scope downtime by eliminating the need for high-level disinfection between procedures. Illumination, image clarity, and ease of insertion are very good, justifying future prospective studies comparing this device to conventional flexible fiberoptic bronchoscopes.
Colt
H G
HG
Pulmonary and Critical Care Divisions of University of California, San Diego Medical Center, USA. hcolt@ucsd.edu
Beamis
J J
JJ
Harrell
J H
JH
Mathur
P M
PM
D020680:Bronchoscopes; D004209:Disposable Equipment; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005336:Fiber Optic Technology; D006801:Humans