FDA Approves a Single-Use Duodenoscope

A duodenoscope is a device used in endoscopic retrograde cholangiopancreatography  (ERCP) procedures, in which a doctor uses them to see the top of the small intestine. For a long time, these devices have been reusable. Criticism has come from many agencies, including the FDA, due to the device-related infections and even fatalities that came from using the same device on multiple patients. Because of this, Ambu has created a single-use duodenoscope which has recently been cleared by the FDA.

About the Single-Use Duodenoscope

Titled the Ambu® aScope™ Duodeno, this device is single-use and comes with a reusable processor unit. Both have received approval from the FDA. Clearance came after a small-scale test of the device, in which 13 gastroenterologists were able to evaluate it.

Results proved that this device works as well as a reusable duodenoscope in terms of scope navigation, quality of image, and efficiency. As a duodenoscope is very useful in the diagnosis of conditions like pancreatitis, gallstones, and cancer in the bile ducts and pancreas, these results are very encouraging.

Further studies will be conducted; multiple centers throughout the United States will test the device on 500 patients. Data from this study should be available during the first quarter of the financial year 2020-2021.

Looking Towards the Future

Hopefully the approval of this device will make ERCP procedures safer for patients. A sterile device can help to put both patients and doctors at ease, making them able to completely focus on the diagnostic and treatment processes.

Ambu is also in the process of creating 15 other devices that are intended to improve the GI field. Three of these devices are also single use: a gastroscope, colonoscope, and cholangioscope. If all goes well, these devices could better the lives of doctors and patients as well.

Click here to read more about this device.

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