Novel Flexible Bronchoscope and Single-Use Disposable-Sheath Endoscope System: A Preliminary Technology Evaluation

Abstract

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). Prospective, multicenter diagnostic technology evaluation of a medical device newly approved by the US Food and Drug Administration. Three tertiary care referral centers with busy bronchoscopy practices. Twenty-four patients undergoing bronchoscopy with a flexible fiberoptic bronchoscope and disposable sheath endoscope system. 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). 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. 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.