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November 20, 2019

FDA approves disposable part for Olympus duodenoscopes

ScopeSeal is a single-use disposable device indicated to reduce duodenoscope contamination during ERCP procedures.
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FDA has announced that it has cleared GI Scientific, LLC’s, ScopeSeal® Duodenoscope Protective Device, the first endoscopic shield for protecting the distal end of a duodenoscope from contamination during ERCP procedures. Cleared for use on the Olympus TJF-Q180V duodenoscope, the device seals the elevator of the scope, providing a sterile disposable barrier to protect from patient-to-patient cross-contamination.

FDA is currently focused on building a healthy pipeline of disposable component duodenoscopes. In August 2019, FDA announced approval of two duodenoscopes with disposable end caps (Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T), which was the first approval in this direction. AGA suspects additional devices are currently under review.

“Protecting our patients by decreasing device transmitted infections is the goal of the AGA. This device is another example of the range of solutions and rapid advances that are being made in providing the safest care to our patients and maintaining access and cost-effectiveness,” said Michael L. Kochman, MD, AGAF, at-large councillor for development and growth on the AGA Governing Board and past chair of the AGA Center for GI Innovation and Technology.

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