FDA Clears New Easier-to-Clean Duodenoscope

Megan Brooks


November 18, 2019

The US Food and Drug Administration (FDA) has cleared the first duodenoscope with a sterile, disposable elevator component that reduces the number of parts that need to be cleaned and reprocessed between uses. It's called the Pentax Medical Video ED34-i10T2.

"Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a statement.

The Pentax Medical Video ED34-i10T2 duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

In August, the FDA recommended duodenoscope manufacturers and healthcare facilities transition to duodenoscopes that have disposable components that may pose less risk to patient safety, as reported by Medscape Medical News.

Disposable designs can simplify or eliminate the need for reprocessing of certain components, which may reduce between-patient duodenoscope contamination. The FDA has previously cleared duodenoscopes with removable endcap components, as reported by Medscape Medical News.

The just-cleared Pentax duodenoscope is the first device with a disposable elevator component, which has been traditionally difficult to clean and reprocess, the FDA said.

"Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the US," Shuren said.

The Pentax Medical Video ED34-i10T2 duodenoscope was reviewed through the premarket clearance (510(k)) pathway. A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.  

As part of the premarket clearance review, the manufacturer submitted evidence to the FDA demonstrating that the device is substantially equivalent to a predicate device.

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