The Food and Drug Administration (FDA) has cleared the first fully disposable duodenoscope, eliminating the risk of infection due to ineffective cleaning and disinfecting.
The disposable device, the EXALT Model D Single-Use Duodenoscope, is manufactured by Boston Scientific. Duodenoscopes are specialized endoscopes used as a less invasive method than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. They consist of a flexible, lighted tube that is threaded through a patient’s mouth and stomach to access the top of the small intestine.
Traditional duodenoscopes are intended to be used on multiple patients, requiring the devices to be cleaned and disinfected, called reprocessing, in between uses to reduce the potential for infections to be passed between patient. But since the devices have small crevasses that can harbor bacteria, they can be difficult to clean. Duodenoscopes have been blamed for multiple outbreaks of superbugs at hospitals among patients treated with duodenoscopes.
In August, the FDA recommended manufacturers of duodenoscopes and health care facilities to transition to duodenoscopes with partially- or fully-disposable designs, which can simplify or eliminate the need for reprocessing, thereby reducing or eliminating the risk of transmitting bacteria from patient-to-patient.
The FDA previously cleared duodenoscopes with disposable endcap and elevator components. The EXALT Model D Single-Use Duodenoscope is the first fully disposable duodenoscope to win FDA clearance.
The EXALT Model D Single-Use Duodenoscope was granted Breakthrough Device design, which enabled the FDA to interact with and guide Boston Scientific as it designed the device.