The FDA has cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The decision marks the latest step in the agency’s four-year battle to reduce bacterial infections that have been linked to duodenoscopes even when users were following proper disinfection or sterilization instructions.
The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.
“We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
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. If not thoroughly cleaned and disinfected, the device can trap contaminated tissue or fluid in its crevices, transmitting infections between patients.
It is critical that hospitals and health care facilities meticulously follow manufacturer’s reprocessing instructions for cleaning and disinfecting duodenoscopes. This lowers the risk of spreading infections between patients. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.
In fall 2013, the Centers for Disease Control and Prevention alerted the FDA to a potential association between multidrug-resistant bacteria and duodenoscopes. Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that the users were following proper manufacturer cleaning and disinfection or sterilization instructions.
In 2015, the FDA convened the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee Meeting to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes. The agency has issued 14 warning letters, inspection complaints, and notices of missing device clearances to three duodenoscope makers. The FDA has also ordered manufacturers to perform post-marketing surveillance studies and issued detailed revised recommendations for cleaning the devices.
In January 2017, the FDA issued a Safety Communication alerting health care providers about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. The communication identified the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope’s distal cap onto the scope. These cracks and gaps could allow fluids and tissue to leak into the duodenoscope.
The new features of the Pentax ED34-i10T include a single-use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved image quality, and a reduced length. The FDA granted clearance of the ED34-i10T to Pentax of America.