Duodenoscope Sheath Protects High-Risk End of Instrument

Duodenoscope Sheath Protects High-Risk End of Instrument

Bret T. Petersen, MD, FASGE, reviewing Pasricha PJ, et al. Gastrointest Endosc 2020 Mar 6.

The risk of transmission of microorganisms by contaminated duodenoscopes remains a pertinent concern for ERCP practices. This report describes microbial challenge studies in a single-use device recently cleared by the Food and Drug Administration (FDA). The device, analogous to a condom, appears to effectively prevent “outside-in” microbial contamination of the high-risk elevator region and the leading end of the endoscope and device channel. The same device also provides “inside-out” protection by sealing in existing contaminants, preventing potential transmission to the patient. Bench studies confirmed that mechanical and optical performance of the endoscope was not compromised by the device.

Bret T. Petersen, MD, FASGE


The FDA is eager to review novel reprocessing, sterilization, and endoscope technologies that will reduce the risk of bacterial transmission. This disposable device appears to protect against transmission from, and to, the elevator region of the endoscope. Further clinical studies are necessary to verify only minimal compromise of the lumen when dual wires and plastic stents are used, the device’s durability in prolonged cases when extreme mechanical forces are involved in serial stent replacements or stone removal, and whether protection of only the leading tip, channel lumen, and elevator region is sufficient to void the risk of bacterial transfer.

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.


Pasricha PJ, Miller S, Carter F, Humphries R. A novel and effective disposable device that provides 2-way protection to the duodenoscope from microbial contamination. Gastrointest Endosc 2020 Mar 6. (Epub ahead of print) (https://doi.org/10.1016/j.gie.2020.03.001)

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