FDA approves Pentax Medical Video Duodenoscope ED34-i10T2 (DEC Duodenoscope).- Pentax Medical
The FDA has given marketing approval for the Pentax Medical Video Duodenoscope ED34-i10T2 (DEC Duodenoscope), the first duodenoscope with a sterile, disposable elevator component. The Pentax Medical Video Duodenoscope ED34-i10T2 allows visualisation and access to the upper gastrointestinal tract to treat bile duct disorders and other associated problems.
According to the FDA, duodenoscopes are used in more than 500,000 less-invasive procedures each year to drain fluids from pancreatic and biliary ducts blocked by cancerous tumours, gallstones or other gastrointestinal conditions. The flexible lighted duodenoscope, threaded through the mouth into the top of the small intestine, has many small working parts and is very difficult to clean. If the device is not properly cleaned and disinfected, it can transmit infection-causing bacteria between patients, since it can trap contaminated tissue or fluid in its crevices. The Pentax Medical Video Duodenoscope ED34-i10T2 is introduced into the patient�s mouth to provide visualisation through a video monitor and therapeutic access to the biliary tract, which includes liver, gall bladder and bile ducts through the upper gastrointestinal tract. Using the Pentax Medical Video Duodenoscope ED34-i10T2 has certain risks, including the potential for injuries, including, but not limited to, burns, electric shock, perforation, infection and bleeding.
In August, the FDA released a safety communication recommending duodenoscope manufacturers and healthcare facilities to switch to duodenoscopes with disposable parts. Disposable duodenoscopes can reduce reprocessing challenges, reducing the transmission of infection-causing bacteria between patients.
With FDA clearance, Pentax Medical Video Duodenoscope ED34-i10T2 has become the first device with a disposable elevator component, the part that is challenging to clean and reprocess.
The DEC Duodenoscope received CE Mark in Europe in September 2017.
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