The Food and Drug Administration (FDA) has cleared the first duodenoscope with a disposable sterile elevator piece, a first in the United States. The design will reduce the number of parts that need to be cleaned and disinfected (reprocessed) between uses.
Duodenoscopes are flexible lighted tubes threaded through the mouth, throat, and stomach into the top of the small intestine. Used in more than 500,000 procedures each year in the United States, they provide a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by gallstones, cancerous tumors, or other gastrointestinal conditions.
In August, the FDA released a safety communication urging companies that manufacture duodenoscopes to move away from designs with permanently attached endcaps, which cannot be removed for cleaning and sterilization.
The Pentax Medical Video ED34-i10T2 model duodenoscope is intended to offer visualization and access to the upper gastrointestinal tract to treat upper gastrointestinal problems. The rationale of the Pentax Medical Video Duodenoscope ED34-i10T2 design is that by reducing reprocessing obstacles, the risk for serious infection will potentially be averted.
In the news release, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, stated: “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. We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess. Today’s clearance is another step in the FDA’s ongoing effort to advance the development and availability of safer duodenoscopes.”
Risks associated with using the new device include the potential for injuries such as burns, electric shock, perforation, infection, and bleeding.
The Pentax Medical Video Duodenoscope ED34-i10T2 was reviewed through the premarket clearance (510(k)) pathway and the FDA granted clearance of the device to Pentax of America.
FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection [news release]. Silver Spring, MD: US Food and Drug Administration; November 15, 2019. https://www.fda.gov/news-events/press-announcements/fda-clears-first-duodenoscope-disposable-elevator-piece-reducing-number-parts-needing-disinfection. Accessed November 15, 2019.