“It is very difficult to consistently clean and disinfect duodenoscopes between patients because of the intricate moving parts at the distal end of these advanced technology instruments. This is true regardless of whether high level disinfection or terminal sterilization is used to reprocess. Buildup of bacteria and other biomatter in recessed areas on these scopes between patients is almost certainly the cause of recent outbreaks. The best way to truly prevent difficult-to-remove contamination at the distal end of the scope is to protect against contamination in the first place, by sealing the distal end, which is exactly what ScopeSeal does. I am excited and relieved that the FDA cleared this device. It will be a game-changer for ERCP infection prevention, complementing existing hospital investments in advanced technology duodenoscopes and sophisticated scope reprocessing,” said Dr. Romney Humphries, former Section Chief, Clinical Microbiology, UCLA Medical System and current Clinical Professor of Pathology, University of Arizona.
Over 700,000 U.S. ERCP procedures and nearly 2 million global ERCP procedures are performed annually as an important less invasive treatment alternative to invasive surgery for assessing and treating critical liver, pancreas, and gallbladder conditions. These highly beneficial, less invasive procedures rely on reusable duodenoscopes as the central enabling technology for these treatments; however, hard-to-clean recessed areas at the distal end of the scope, especially the recessed elevator area, have been linked to failures to remove biomatter contamination from the scope through scope disinfection and reprocessing efforts, resulting in patient-to-patient cross contamination and multiple drug-resistant infections. Significant infection outbreaks and multiple deaths have been reported from drug-resistant infections linked to contaminated duodenoscopes.
ScopeSeal easily and securely attaches to the distal end of a reusable duodenoscope to create Two-Way Protection for 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.
“The clearance of ScopeSeal for human use is a reminder of the FDA’s continued commitment to creating a safe environment for patients undergoing these critical, highly beneficial procedures. We are excited about the introduction of this important single-use disposable technology to address infection concerns with reusable duodenoscopes,” said Scott Miller, CEO and co-founder of GI Scientific.
ScopeSeal is cleared for use on the Olympus TJF-Q180V duodenoscope, the duodenoscope used in approximately 85% of U.S. ERCP procedures, and is compatible with instruments used in ERCP up to 10.7 Fr in diameter. ScopeSeal is not a replacement for careful adherence to the important and valuable duodenoscope reprocessing steps and related scope maintenance requirements specified by the reusable duodenoscope manufacturer.
The ScopeSeal infection control technology is a platform applicable to other scopes and indications, including duodenoscopes with non-sealing disposable caps, which the company is evaluating with respect to pursuing additional, future regulatory clearances.