Disposable-sheath, flexible gastroscope system versus standard gastroscopes: a prospective, randomized trial

Background: Endoscopically transmitted infections due to inadequate disinfection are rare but well-recognized complications. A new prototype of a flexible, fiberoptic endoscope has been developed that uses a disposable sheath to cover and protect all working surfaces of the endoscope from contamination. The present study investigated the function, reprocessing, and hygienic status of this endoscope system in comparison with standard systems. Methods: In a prospective, randomized trial, 100 upper endoscopic procedures (50 standard, 50 sheathed) were performed. Analog rating scales were used to evaluate endoscopic performance and reprocessing. Reprocessing time, procedure duration, insertion depth, total instrument downtime, and problems occurring during the procedure were recorded. Microbiologic swabs were obtained from each endoscope. Results: Mean procedure duration was slightly longer with the sheathed system than with standard endoscope (9.9 vs. 8.4 min). Set up and reprocessing times, however, were significantly shorter with the Endosheath (8.9 vs. 48.4 min with the standard endoscope). The disposable-sheath endoscope system permits the rate of performance of procedures to be increased by a factor of up to 3.0. Both endoscopists and reprocessing personnel preferred the standard endoscope. No post-procedure sheath leakage or rupture was seen. Conclusion: Our results suggest that the "disposable endoscope" may have important advantages in terms of decreased instrument turn-around time and potentially improved safety.