Chest
Volume 118, Issue 1, July 2000, Pages 183-187
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Bronchoscopy
Novel Flexible Bronchoscope and Single-Use Disposable-Sheath Endoscope System: A Preliminary Technology Evaluation

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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 Administration.

Setting

Three tertiary care referral centers with busy bronchoscopy practices.

Patients

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.

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 bronchoscopes.

Section snippets

Study Protocol

The protocol for this study was written and executed by the authors at the request of the manufacturer. The manufacturer did not dictate study design or participate in results analysis. The primary aim of this study was to measure overall performance of the medical device. No comparisons with preexisting instruments were attempted. The study was approved by the Institutional Review Board at each study site.

The three study sites were chosen by the manufacturer. The investigators at each of the

Results

Twenty-four patients at three institutions participated in this study. None of the procedures were terminated prematurely because of instrument malfunction, although an operator switched to a conventional bronchoscope on one occasion. Bronchoscopists in two of the participating institutions noted that the conversion of the fiberoptic-derived image was not always ideal when a video camera was placed onto the head of the bronchoscope using a standard C mount. It was also occasionally difficult to

Discussion

The results of this preliminary evaluation demonstrate the acceptable optics and handling profile of this novel system. We believe this justifies consideration for its introduction into general bronchoscopic practice, particularly since the system has been approved by the US Food and Drug Administration, and similar systems are already being used for flexible sigmoidoscopy10 and nasopharyngeal laryngoscopy.11

Current technology does not allow incorporation of a distal charge-coupled device into

References (11)

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This work was supported in part by Vision Sciences, Natick, MA, who provided the investigators with a Vision Sciences B-F 100 flexible fiberoptic bronchoscope, BS-F21 EndoSheath bronchoscope barriers, and technical support as needed at no cost throughout the duration of the study.

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