The US Food and Drug Administration (FDA) has given marketing approval for the Pentax Medical Video Duodenoscope ED34-i10T2, 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.
FDA’s Center 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 US.”
In contrast to conventional surgery, the flexible, lighted duodenoscopes are used as a less invasive approach to remove fluids from pancreatic and biliary ducts. It is used in over 500,000 procedures annually in the US.
The typical duodenoscope threads through the mouth into the top of the small intestine. As it has several small working parts, cleaning and reprocessing can become a challenge. If not properly cleaned and disinfected, contaminated tissue or fluids can become trapped in its crevices, transmitting infection-causing bacteria between patients.
Earlier, the regulatory agency had communicated to healthcare facilities about the appropriate steps to be taken while cleaning and disinfecting the devices between use.
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.
Previously, the agency approved duodenoscopes with removable endcap components.
With 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 Pentax Medical Video Duodenoscope ED34-i10T2 is designed for use with endoscopic devices for visualisation through a video monitor, providing access to the biliary tract.
Risks associated with using Pentax Medical Video Duodenoscope ED34-i10T2 include burns, electric shock, perforation, bleeding and infection.