Single-Use Duodenoscope Functionality Excellent in Early Studies

Pancreatobiliary

Bret T. Petersen, MD, MASGE reviewing Muthusamy VR, et al. Clin Gastroenterol Hepatol 2019 Nov 6 and Ross A, et al. Gastrointest Endosc 2020 Feb.

Two companies (Boston Scientific, Marlboro, Massachusetts, and Ambu A/S, Copenhagen, Denmark) have developed single-use duodenoscopes as a means for avoiding potential patient-to-patient transmission of infections. This set of articles presents data from simulated evaluation in a synthetic bench model and the initial clinical experience for the first FDA-cleared instrument (EXALT Model D Duodenoscope, Boston Scientific).

When compared to three makes of reusable instruments in a lab setting, the Exalt instrument compared favorably in most parameters, including overall performance, navigation/pushability, and tip control. In addition, the single-use instrument matched the image quality of two of the reusable instruments but had better image quality than the third reusable instrument. In a 6-center case series involving 13 human “roll-in” cases of intubation without cannulation plus 60 standard ERCPs, 58 of 60 full cases were successfully completed with the study instrument, while 2 crossed over to single-use instruments for confirmation of findings or success. Median physician satisfaction with the single-use instrument was rated a 9 out of 10. The full spectrum of procedural complexities graded by the American Society for Gastrointestinal Endoscopy was encountered.

Comment:

These data, and experience with another instrument, demonstrate that single-use duodenoscopes will be fully functional for most and perhaps all patients, thereby offering a solution for the risk of infection transmission. The dominant remaining questions pertain to costs and cost-effectiveness, expense versus current practices when used selectively or uniformly, patient and situational parameters for use, and acceptability of the solutions for the waste stream. All practices performing ERCP will need to wrestle with these issues and the evolving options for standard reprocessing and sterilization to adopt local solutions.

Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.

Bret T. Petersen, MD, MASGE

Bio and Disclosures

Citation(s):

Muthusamy VR, Bruno MJ, Kozarek RA, et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 2019 Nov 6. (Epub ahead of print) (https://doi.org/10.1016/j.cgh.2019.10.052)

Ross AS, Bruno MJ, Kozarek RA, et al. Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison. Gastrointest Endosc 2020;91:396-403. (https://doi.org/10.1016/j.gie.2019.08.032)