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FDA News Release

FDA clears first duodenoscope with disposable distal cap

For Immediate Release

September 20, 2017

Release

The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

“We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients.”

Duodenoscopes are used in more than 500,000 procedures each year as a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. The flexible lighted duodenoscope, which is threaded through the mouth into the top of the small intestine, is a complex medical device with many small working parts that can be difficult to clean. If not thoroughly cleaned and disinfected, the device can trap contaminated tissue or fluid in its crevices, transmitting infections between patients.

It is critical that hospitals and health care facilities meticulously follow manufacturer’s reprocessing instructions for cleaning and disinfecting duodenoscopes. This lowers the risk of spreading infections between patients. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients. 

In January 2017, the FDA issued a Safety Communication alerting health care providers about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. The communication identified the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope’s distal cap onto the scope. These cracks and gaps could allow fluids and tissue to leak into the duodenoscope.

The new features of the Pentax ED34-i10T include a single use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved image quality, and a reduced length. The FDA granted clearance of the ED34-i10T to Pentax of America.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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