Authors: Danny A. Sherwinter, MD and Pascal Bortz, MD
GI Scientific received FDA approval for the ScopeSeal® Duodenoscope Protective Device on October 24, 2019.
The ScopeSeal® is a duodenoscope protective device. It is 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. It also seals the duodenoscope’s hard-to-clean elevator area.
ScopeSeal® is placed on the distal end of the scope and works as an “Outside-In” barrier designed to significantly reduce bio-matter 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. There is no degradation of scope optical performance or mechanical functionality.
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: it allows for post-procedure flushing of the scope’s internal instrument channel while sealing the elevator area from bio-matter contamination during this important step prior to reprocessing. ScopeSeal® is not a replacement for post-procedure high level disinfection and/or sterilization to reprocess the scope.
ScopeSeal® is cleared for use on the Olympus TJF-Q180V duodenoscope.
A March 6 2020 study displayed that, in dye immersion tests, there was a complete seal with no leakage and no compromise of the optical and mechanical performance. Rigorous microbial challenge tests showed protection with pre-existing microbial biofilm on or around the elevator that may have survived reprocessing
Indications: For endoscopic procedures using the Olympus TJF-Q180V duodenoscope
Contraindications: For any scope other than above
