GI Scientific, an Arlington, Virginia firm, has won FDA clearance for the first duodenoscope attachment that helps to protect the imaging end from infections.
Duodenoscopes are used in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. A few years ago it was discovered that they are carriers of infections, because of design flaws and insufficient processing, causing multiple deaths as well as a shock to the scope industry. The ScopeSeal helps to make sure that pathogens don’t get a chance to make contact with the elevator end of a duodenoscope, where bacteria tend to have an easier time settling.
“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,” said Dr. Romney Humphries, Clinical Professor of Pathology, University of Arizona, in a GI Scientific press release. “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”.
The ScopeSeal comes sterilized and can simply be tossed away after a procedure, but the clinic can choose to keep them on in order to perform a “pre-cleaning” that helps to make sure nothing gets onto the elevator end once the shield is removed.
During procedures, physicians can still pass instruments through the scope into the GI tract, and the way the ScopeSeal is designed helps to make sure that these instruments don’t come in contact with the imaging components.
The device is currently only FDA cleared for use with the Olympus TJF-Q180V, but this duodenoscope accounts for about 85% of all ERCP procedures performed in the U.S.
Product page: ScopeSeal
Via: GI Scientific