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.


CONCLUSIONS
Our results suggest that the "disposable endoscope" may have important advantages in terms of decreased instrument turn-around time and potentially improved safety.
Mayinger
B
B
Department of Medicine I, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany. mayinger@med1.med.uni-erlangen.de
Strenkert
M
M
Hochberger
J
J
Martus
P
P
Kunz
B
B
Hahn
E G
EG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001291:Attitude of Health Personnel; D001419:Bacteria / Q000302:isolation & purification; D004209:Disposable Equipment; D004866:Equipment Contamination; D005260:Female; D020699:Gastroscopes; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies