FDA Clears First Duodenoscope With Disposable Elevator Component To Reduce Infection Risk

The United States Food and Drug Administration (FDA) has cleared the first duodenoscope on the market with a disposable elevator piece. The industry believes that a move to disposable parts, like the elevator, will help reduce infection risks. The elevators of duodenoscopes have been identified in numerous instances as a difficult to clean component that can ultimately lead to the spread of infection if they are not properly disinfected.

The FDA granted clearance to the Video ED34-i10T2 model duodenoscope made by Pentax Medical, the first duodenoscope with disposable components on the market. The press release put out by the FDA continues:

“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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

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, which is threaded through the mouth into the top of the small intestine, is a complex medical device with many small working parts that can be difficult to clean. The device can trap contaminated tissue or fluid in its crevices, and if not thoroughly cleaned and disinfected, it can transmit infection-causing bacteria between patients.

The FDA has previously issued communications to health care facilities about following appropriate steps for cleaning and disinfecting these devices between use. In August, the FDA released a safety communication recommending that duodenoscope manufacturers and health care facilities transition to duodenoscopes with disposable components. Disposable designs can simplify or eliminate the need for reprocessing of certain components, which may reduce between-patient duodenoscope contamination. The FDA has previously cleared duodenoscopes with removable endcap components. Today’s clearance is the first device with a disposable elevator component — a part that has been traditionally difficult to clean and reprocess. The elevator part of the duodenoscope facilitates access to the bile and pancreatic ducts, and is used to position endoscopic instruments during the procedure.

Read the entire release here: FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection

While the transition from rigid end caps, to disposable end caps to potentially fully disposable duodenoscopes takes place, hospitals must make sure that their staff is following the proper protocols each and every time a duodenoscope is disinfected. Systems such as iRIScope can display the proper workflow for reprocessing duodenoscopes and document the process automatically. Any breaches of protocol can be alerted in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer everyone the peace of mind that duodenoscopes and all other flexible endoscopes are being properly reprocessed every single time.