The Food and Drug Administration (FDA) has cleared the first duodenoscope with fewer parts designed to make the cleaning and disinfecting (known as reprocessing) of the specialized endoscopes more efficient in order to reduce the risk of spreading disease-causing bacteria from patient to patient.
The Pentax Medical Video ED34-i10T2 model duodenoscope, used to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems, has a sterile, disposable elevator component, which FDA director of the Center for Devices and Radiological Health Jeff Shuren, MD, JD, called a “major step” toward the agency’s ongoing effort to advance the development and availability of safer duodenoscopes.
Duodenoscopes are used in more than a half million procedures each year as a less invasive alternative to surgery for draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other gastrointestinal conditions. The flexible, lighted device is threaded through the mouth and esophagus into the small intestines.
Duodenoscopes contain many working parts that can be difficult to clean, allowing bacteria to harbor in its small crevasses. If not thoroughly cleaned and disinfected between uses, the device can spread infection-causing bacteria between patients. Duodenoscopes have been blamed for several superbug outbreaks at hospitals across the country.
Once the issue was identified, the FDA called on medical device manufacturers to pursue innovations designed to help reduce risk to patients, and for hospitals and other health care facilities where procedures using duodenoscopes are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess.