FDA Clears First Duodenoscope With Sterile, Disposable Component
The FDA has cleared for marketing the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses.
The US Food and Drug Administration (FDA) has cleared the first duodenoscope with a sterile, disposable elevator piece for marketing. The disposable elevator component will reduce the number of parts required to be cleaned and disinfected between uses.
The Pentax Medical Video ED34-i10T2 model duodenoscope will allow visualization and access to the upper gastrointestinal tract for the treatment of bile duct disorders and other upper gastrointestinal problems. The clearance of the ED34-i10T2 was granted to Pentax of America.
In Fall 2013, the US Centers for Disease Control and Prevention (CDC) alerted the FDA to a possible association between duodenoscopes and multidrug-resistant bacteria, and investigation revealed that cases of infection were occurring even when users followed proper manufacturer cleaning and sterilization instructions. Duodenoscopes are used for over 500,000 procedures annually and present a less invasive way to drain fluids from pancreatic and biliary ducts than conventional surgeries.
“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the agency's statement.
The Pentax Medical Video Duodenoscope ED34-i10T2 is used with endoscopic devices to provide visualization via a video monitor and access to the biliary tract. Risks of the Pentax Medical Video Duodenoscope ED34-i10T2 include potential for injuries such as burns, electric shock, perforation, bleeding, and infection.
The duodenoscope was reviewed via the premarket clearance (510(k)) pathway. As part of the premarket clearance review, the manufacturer submitted evidence to the FDA demonstrating that the device is similar to previous duodenoscopes. Shuren stated that “today’s clearance is another step in the FDA’s ongoing effort to advance the development and availability of safer duodenoscopes."