Duodenoscope redesign prompts voluntary recall by Pentax


Pentax has issued a voluntary recall for Pentax ED-3490TK duodenoscopes because of infections associated with reprocessed duodenoscopes, and the Food and Drug Administration has cleared the 510(k) to improve the device. The new design will, it is hoped, improve cleaning and disinfection for these devices.

“Reducing infections associated with duodenoscopes remains a top priority for the FDA, and we believe the new design changes to the Pentax duodenoscope will make these devices easier to clean and high-level disinfect to help enhance their safety,” said Suzanne Schwartz, MD, associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health. “We will continue to encourage new innovations for these devices to protect public health while enabling patients to have continued access to minimally invasive, life-saving endoscopy procedures.”

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The newly cleared 510(k) for the ED-3490TK model involves a new elevator channel sealing mechanism at the tip of the scope. This feature is designed to prevent the seepage of fluids and bacteria into the crevices on the device that are difficult to clean, which could be a potential source of infection when used on another patient.

The addition of the elevator channel sealing mechanism is a welcome tool for physicians because of the risk of infections posed by reprocessed duodenoscopes. In one study, even after double high-level disinfection or standard high-level disinfection followed by ethylene oxide gas sterilization, duodenoscopes had similar rates of contamination. These contamination events were associated with outbreaks of carbapenem-resistant Enterobacteriaceae infections. One of the culprits behind residual contamination may be the presence of biofilms, which are notoriously difficult to clean with standard disinfection methods.

Prior to the clearance of the elevator channel sealing mechanism, the first duodenoscope with a disposable distal cap was introduced, the Pentax ED34-i10T. The use of a disposable tip for the duodenoscope is meant to decrease the risk of future infections associated with these devices. The use of a disposable tip also improves cleaning and reprocessing of the duodenoscopes.

The FDA continues to work with manufacturers to improve the safety of duodenscopes and other reusable medical devices to protect patients from bacterial infections.

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