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).
Design: Prospective, multicenter diagnostic technology
evaluation of a medical device newly approved by the US Food and Drug
Setting: Three tertiary care referral
centers with busy bronchoscopy practices.
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).
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.
Conclusion: 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