ScopeSeal will protect the distal end of a duodenoscope from contamination during ERCP procedures
Image: The pictures of ScopeSeal protective device. Photo: courtesy of Business Wire.
GI Scientific has secured approval from the US Food and Drug Administration (FDA) for its ScopeSeal duodenoscope protective device.
ScopeSeal is said to be the first Endoscopic Shield to protect the distal end of a duodenoscope from contamination during endoscopic retrograde cholangio-pancreatography (ERCP) procedures.
ScopeSeal is a single-use disposable infection control device, which protects duodenoscope optics and other crucial functionality while sealing the infection prone distal end of the Olympus duodenoscope used in ERCP procedures.
The approval allows using ScopeSeal on the Olympus TJF-Q180V duodenoscope, which is used in around 85% of US ERCP procedures. It is also compatible with instruments used in ERCP up to 10.7 Fr in diameter.
ScopeSeal is the only device approved for human use by FDA
ScopeSeal is claimed to be the only device cleared for human use by the FDA that seals the elevator area of the scope and significantly minimises duodenoscope distal end contamination during use.
The device can be easily and securely connected with the distal end of a reusable duodenoscope to create two-way protection for the scope that includes an “Outside-In” barrier to decrease biomatter soiling of the distal end of the scope during use.
The “Inside-Out” protection is for sealing the elevator area of the scope and facilitating a sealed passageway to allow instruments pass via duodenoscope into the patient’s GI tract without contacting the elevator area of the scope.
The two-way protection is similar to a physician wearing gloves for surgery, which protects both the patient and the surgeon from contamination and potential infection.
GI Scientific CEO and co-founder Scott Miller said: “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.”
The ScopeSeal infection control technology is a platform, which can be used with other scopes and indications such as duodenoscopes with non-sealing disposable caps.
In April this year, Advanced Sterilization Products (ASP) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its 22-minute Aeroflex automatic endoscope reprocessor (AER).