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

Area of Science:

• Gastroenterology
• Infectious Disease Prevention
• Medical Device Innovation

Background:

• Inadequate endoscope disinfection can lead to rare but serious infections.
• A new disposable sheath design aims to prevent contamination of flexible fiberoptic endoscopes.
• This study compares the new sheathed system to standard endoscopes regarding function and hygiene.

Purpose of the Study:

• To evaluate the function, reprocessing, and hygienic status of a novel disposable endoscope sheath system.
• To compare the performance and efficiency of the sheathed endoscope system against standard endoscopes.
• To assess the potential impact of the disposable sheath on infection control and workflow.

Main Methods:

• A prospective, randomized trial involving 100 upper endoscopic procedures (50 standard, 50 sheathed).
• Evaluation of endoscopic performance and reprocessing using analog rating scales.
• Recording of procedure duration, setup/reprocessing times, instrument downtime, and procedural issues; microbiologic swabs were collected.

Main Results:

• The sheathed system had a slightly longer mean procedure duration (9.9 vs. 8.4 min).
• Significantly shorter setup and reprocessing times were observed with the sheathed endoscope (8.9 vs. 48.4 min).
• The disposable-sheath system increased the procedure performance rate up to threefold; no sheath leakage or rupture occurred.

Conclusions:

• The disposable endoscope sheath system demonstrates significant advantages in reducing instrument turn-around time.
• The system offers potential improvements in patient safety by minimizing contamination risks.
• While endoscopists preferred the standard endoscope, the sheathed system enhances workflow efficiency.