GI Scientific said today that the FDA cleared its ScopeSeal duodenoscope protective device for protecting the distal end of a duodenoscope from contamination during endoscopic retrogade cholangio-pancreatography procedures.
ScopeSeal is a single-use device designed to seal the infection-prone distal end of a duodenoscope by attaching to the end and reducing biomatter soiling during use. It is designed to seal the elevator area of the scope to provide a sealed passageway, allowing instruments to be passed through the duodenoscope and into the patient’s GI tract as well.
The device is cleared for use on the Olympus TJF-Q180V duodenoscope, which GI Scientific said is used in approximately 85% of ERCP procedures in the U.S. GI Scientific added that the device is compatible with other scopes and indications and the company is pursuing additional regulatory clearances for it.
Arlington, Va.-based GI Scientific said the ScopeSeal is the only device cleared by the FDA for human use that seals the elevator area of the scope and significantly reduces contamination of the distal end during use.
“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,” CEO & co-founder Scott Miller said in prepared remarks. “We are excited about the introduction of this important single-use disposable technology to address infection concerns with reusable duodenoscopes.”
“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,” added University of Arizona professor of pathology Dr. Romney Humphries. “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.”