U.S. FDA Clears ScopeSeal®, the Only Single-Use Disposable Device that Seals the Duodenoscope’s Elevator Area and Significantly Reduces Scope Contamination During ERCP Procedures

ScopeSeal® Features

The ScopeSeal® Duodenoscope Protective Device is the first Endoscopic Shield™, a sterile, single-use disposable device that attaches to the distal end of a duodenoscope to act as a protective barrier to significantly reduce the level of contamination of the scope’s distal end during patient use. The ScopeSeal® technology includes a protective barrier sealing the duodenoscope’s hard-to-clean elevator area during patient use.

ScopeSeal® provides Two-Way Protection™  for the distal end of the scope:  an “Outside-In” barrier designed to significantly reduce biomatter soiling of the distal end of the scope during use and “Inside-Out” protection which seals the elevator area of the scope and provides a sealed passageway allowing instruments to be passed through the duodenoscope into the patient’s GI tract without contacting the elevator area of the scope.

ScopeSeal®’s Two-Way Protection™ is analogous to a physician wearing gloves for surgery, which along with vigorous scrubbing and washing before and after the procedure, protects both the patient and the surgeon from contamination and potential infection.

Duodenoscope used to access biliary tract in ERCP procedure

Duodenoscope in an ERCP procedure

ScopeSeal® Technology and Benefits

ScopeSeal®’s sophisticated and proprietary features preserve scope optical performance and mechanical functionality, while adding novel barrier/shield infection control properties to significantly reduce duodenoscope distal end contamination.

ScopeSeal® provides a further protective benefit when kept on the scope after use during the performance of the ScopeSeal® Pre-Cleaning Procedure™. This procedure has another important benefit allowing for post-procedure flushing of the scope’s internal instrument channel while sealing the elevator area from biomatter contamination during this important step prior to reprocessing. ScopeSeal® is cleared for use on the Olympus TJF-Q180V duodenoscope.

ScopeSeal® is not a replacement for post-procedure high level disinfection and/or sterilization to reprocess the scope.  ScopeSeal® acts as a barrier to protect against contamination of the duodenoscope’s distal end in the first place, before engaging in the benefits of reprocessing. No capital equipment investment is required to access ScopeSeal®’s infection control benefits and ScopeSeal® works within current hospital work-flow and procedure economics.