FDA Approves Disposable Device to Reduce Scope Contamination, Outbreaks

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The U.S. Food and Drug Administration (FDA) today cleared GI Scientific’s single-use, disposable infection control device which protects the distal end of a duodenoscope from contamination during endoscopic retrograde cholangiopancreatography (ERCP) procedures.

GI Scientific is a medical device company focused on developing innovations for gastrointestinal disease. Its device, ScopeSeal, preserves duodenoscope optics while sealing the infection-prone end of the scope used during ERCP procedures.

ScopeSeal attaches to the end of a reusable duodenoscope and creates Two-Way Protection for the scope. An outside-in barrier reduces biomatter soiling of the distal end of the scope during use. Inside-out protection seals the elevator area of the scope and provides a sealed passageway through the scope and into the patient’s gastrointestinal tract without touching the elevator area.

Consistently cleaning and disinfecting the scopes between patients is difficult because of the moving parts at the end of the technology, said Romney Humphries, Ph.D., clinical professor of pathology at the University of Arizona.

“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,” he said.

Bacteria and biomatter build up in the scope between patients likely caused recent outbreaks, Humphries added.

“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,” said Scott Miller, MBA, CEO and co-founder of GI Scientific. “We are excited about the introduction of this important single-use disposable technology to address infection concerns with reusable duodenoscopes.”

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