- FDA cleared the first duodenoscope with a sterile, disposable elevator component Friday in an effort to cut down on the risk of infection from reprocessing the class of devices. The marketing authorization, granted to Pentax of America, follows GI Scientific's clearance for an adjunctive device to shield the distal end of a duodenoscope in October and previous clearances for duodenoscopes with removable endcaps.
- Duodenoscopes, devices used in endoscopic retrograde cholangiopancreatography procedures to diagnose or treat bile duct, liver, gall bladder and pancreas issues, have been linked to persistent contamination issues related to inadequate reprocessing of the devices.
- In August, FDA issued a safety communication urging the development of new types of duodenoscopes with disposable parts due to the risk of infection from fixed endcap models.
Center for Devices and Radiological Health Director Jeff Shuren called the Pentax clearance "another major step toward lowering the risk of infection among patients," calling duodenoscope safety a top priority for the agency.
"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," Shuren said in a statement.
The new Pentax Medical Video Duodenoscope ED34-i10T2 is notable because FDA identified the elevator component as a traditionally difficult part to properly clean. The part is used to access the bile and pancreatic ducts by helping to guide duodenoscope endoscopic instruments.
Between Oct. 15, 2018, and March 31, adverse event reports showing three deaths associated with duodenoscopes, 45 patient infections and 159 cases of device contamination were reported, according to FDA.
Risks of using the device include "potential for injuries, including, but not limited to, burns, electric shock, perforation, infection and bleeding," according to FDA.
On Nov. 8, FDA convened an advisory committee to give recommendations on how to reduce the risk of duodenoscope infections between patients. The meeting follows scrutiny of duodenoscope safety by Senate health committee Ranking Member Patty Murray, D-Wash.
The panel noted complicated instructions for reprocessing of the devices and poor work conditions for low-paid employees contributed significantly to inadequate cleaning of duodenoscopes. It also agreed with FDA that standardized durability testing would help decrease the risk of infection.
Single-use duodenoscopes are currently being developed by Boston Scientific and Danish medical device firm Ambu.