The FDA authorises marketing of duodenoscopes with disposable elevator component for use with endoscopic devices.
M2 PHARMA-November 18, 2019-The FDA authorises marketing of duodenoscopes with disposable elevator component for use with endoscopic devices
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Public health agency the US Food and Drug Administration announced on Friday that it has approved the marketing of the first duodenoscope in the US with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected in between uses under its premarket clearance (510(k)) pathway.
The FDA reportedly granted clearance of the ED34-i10T2 to Pentax of America.
Additionally, the agency stated the Pentax Medical Video ED34-i10T2 model duodenoscope is intended to to be used with endoscopic devices and provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. The first duodenoscope with disposable elevator piece reduces the number of parts needing disinfection.
In August, the FDA released a safety communication recommending that duodenoscope manufacturers and health care facilities transition to duodenoscopes with disposable components. Disposable designs can simplify or eliminate the need for reprocessing of certain components, which may reduce between-patient duodenoscope contamination.
This FDA clearance is the first duodenoscope device with a disposable elevator component -- a part that has been traditionally difficult to clean and reprocess.
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|Date:||Nov 18, 2019|
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