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
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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](https://www.giscientific.com/wp-content/uploads/2019/09/scopeseal-2.jpg)
Duodenoscope in an ERCP procedure
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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.