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

Background: Endoscopically transmitted infections due to inadequate disinfe ction are rare but well-recognized complications. A new prototype of a flex ible, fiberoptic endoscope has been developed that uses a disposable sheath to cover and protect all working surfaces of the endoscope from contaminat ion. The present study investigated the function, reprocessing, and hygieni c status of this endoscope system in comparison with standard systems. Methods: In a prospective, randomized trial, 100 upper endoscopic procedure s (50 standard, 50 sheathed) were performed. Analog rating scales were used to evaluate endoscopic performance and reprocessing. Reprocessing time, pr ocedure duration, insertion depth, total instrument downtime, and problems occurring during the procedure were recorded. Microbiologic swabs were obta ined from each endoscope. Results: Mean procedure duration was slightly longer with the sheathed syst em 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 o f up to 3.0. Both endoscopists and reprocessing personnel preferred the sta ndard endoscope. No post-procedure sheath leakage or rupture was seen. Conclusion: Our results suggest that the "disposable endoscope" may have im portant advantages in terms of decreased instrument turn-around time and po tentially improved safety.