As part of its quest to prevent duodenoscopes from spreading infections, the FDA has approved marketing of the first such device with a disposable “elevator”—a part that has traditionally proven difficult to clean and sterilize.
The elevator, which allows access to the bile and pancreatic ducts, is used to position endoscopic instruments during procedures. A disposable elevator will reduce the number of parts that must be disinfected (“reprocessed,” in FDA parlance) between uses.
The newly approved Pentax Medical Video ED34-i10T2 duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.
“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. Improving duodenoscope safety is a “top priority” of the agency, he added, calling on health care facilities to switch to easier-to-reprocess duodenoscopes with disposable components. The FDA has previously cleared duodenoscopes with removable endcap components.
Duodenoscopes are used in more than 500,000 procedures each year as a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other gastrointestinal conditions. The flexible, lighted duodenoscope is a complex device with many small working parts that can be difficult to rid of infection-causing bacteria between patients.
The FDA has seen a decline in the number of duodenoscope-related medical device reports associated with patient infections since measures to improve reprocessing were implemented beginning in 2015. Still, problems persist. An FDA analysis of 205 medical device reports received from October 15, 2018, through March 31, 2019, includes 45 reports of patient infection, one report of patient exposure, and 159 reports of device contamination. In 2018, three deaths were reported in the U.S. related to duodenoscopes.