The new device is claimed to be the first duodenoscope with a sterile disposable elevator component, and has been designed to reduce the parts required to be cleaned and disinfected (reprocessed) in between uses.
The Pentax Medical Video ED34-i10T2 model duodenoscope offers visualisation and access to the upper gastrointestinal (GI) tract and is intended for use in treating bile duct disorders and other upper GI problems.
FDA Centre for Devices and Radiological Health director Jeff Shuren said: “Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices.
“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 U.S.”
FDA has reviewed the device through the premarket clearance (510(k)) pathway
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.
The company has submitted evidence to the FDA as part of the premarket clearance review, which showed that the device is substantially equivalent to a predicate device.
