Closed-channel duodenoscopes are used in more than 500,000 procedures each year, and are difficult to clean and disinfect. Scopes contaminated with deadly superbug bacteria have been reused time and again, infecting hundreds of patients across the country. Endoscopy infections have occured in hospitals nationwide.

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Gastroenterologist setting up endoscope representing the FDA issuing warning letters for medical device reporting.

FDA Issues Endoscope Warning Letters

MedTruth Editors · January 26, 2023

After a series of facility inspections, the leading manufacturer of endoscopes was found to have violated medical device reporting requirements and quality system regulations.

FDA Regulation
A photo of a medical assistant holding a duodenoscope, representing the recent FDA approval for a disposable, single use endoscopy device.

FDA Approves First Single-Use, Disposabl...

James Parker · January 6, 2020

The Exalt Model D, manufactured by Boston Scientific, is the first single-use duodenoscope approved for physicians.

FDA Regulation
A photo of an FDA-recommended disposable duodenoscope, prior to recommendations to use disposable duodenoscopes.

FDA Encourages Use of Disposable Duodeno...

Tess Francke · November 18, 2019

Traditional duodenoscopes may cause infection. The FDA recommends hospitals transition to disposable duodenoscopes and warns against illegal ATP test strips used to determine cleanliness.

FDA Regulation
A duodenoscope probe held in a doctors hand, potentially contaminated with bacteria.

How Duodenoscopes Spread Antibiotic-Resistant Bacteria

Ashley Lombardo · November 2, 2016

Duodenoscopes, commonly reused medical devices, may become infected with antibiotic-resistant bacteria. A duodenoscope infection may be fatal.