This article describes an early randomized German trial by Mayinger et al of a prototype disposable sheath (reusable endoscope and EndoSheath® Technology, Vision Sciences, Orangeburg, NY) in upper gastrointestinal gastroscopy. The EndoSheath® system was compared with a standard endoscope (GIF Q30, Olympus, Hamburg, Germany) with respect to setup and reprocessing times, procedure duration, downtime, number of biopsies, instances of contamination, problems during handling, and several specific aspects of handling and use. One hundred patients with various indications for gastroscopy (primarily upper abdominal pain, anemia, suspected reflux disease, and tumor evaluation) were enrolled in the study, and 50 were randomly assigned to each endoscope group.
The two physicians, four endoscopy nurses, and patients who participated in the study used a 10-point scale to rate each endoscope system, with 10 representing a perfect score and 0 the worst possible score. After each gastroscopic procedure, the standard endoscope was reprocessed in accordance with the protocol in place at the authors’ institution and the EndoSheath® Technology endoscope in accordance with the manufacturer’s recommendations. Samples for microbiologic analysis were taken from three sites on the sheathed endoscope after each procedure (and removal of the EndoSheath® Technology). Samples were obtained from the standard endoscope after regular disinfection, but before use, by rinsing the accessory and water channels with 0.9% saline. All used sheaths were examined for leakage by inflating them with air (0.3 kg/cm2) for 2 minutes.
The mean duration of the gastroscopy procedure was slightly longer with the EndoSheath® system than with the standard endoscope, but the difference was not significant. The mean setup time was about 6 minutes for the EndoSheath® system and 0.5 minutes for the standard system (P < 0.05). The reprocessing time and total instrument turnaround time were significantly shorter with the EndoSheath® system (about 3 versus 48 minutes and 19 versus 56 minutes, respectively; P < 0.05). The standard endoscope was preferred by the endoscopists for each item rated, whereas the EndoSheath® system was preferred by the nurses for its ease of reprocessing and staff safety. However, both the physicians’ and the nurses’ scores for the EndoSheath® system improved with the number of procedures and approached those for the standard instrument by the end of the study. There were no differences between the two endoscope groups in patients’ scores.
Problems with handling were more commonly reported in the EndoSheath® Technology group, primarily during the first half of the study, thereby indicating the presence of what the researchers termed a “marked learning-curve effect.”The leakage tests never showed any breach in the disposable sheaths. Microbial contamination (with apathogenic common environmental and human-flora bacteria only) was found after 10% of standard gastroscopy procedures and 16% of EndoSheath® Technology procedures. Because no EndoSheath® barriers were found to have a leak, Mayinger et al assumed that contamination of the sheathed endoscope was the result of improper handling (for example, pushing the endoscope out of the sheath onto a contaminated surface or grasping the endoscope with contaminated gloves).
The researchers noted that the most striking advantage of the EndoSheath® Technology revealed by their study was the shortening of reprocessing time, which permitted a potential tripling of the number of gastroscopy procedures. They also commented that the use of EndoSheath® Technology might allow endoscopy in settings in which the number of endoscopes and the resources for cleaning them are limited (for example, primary care clinics, mobile screening programs, and intensive care units). Mayinger et al concluded that the EndoSheath® Technology offers a new standard for endoscope reprocessing that has important advantages in terms of decreased instrument turnaround time and a possible increase in safety for both health care staff and patients.