The FDA Dec. 13 approved Boston Scientific’s device, the first fully disposable duodenoscope, designed to reduce the risk of infections in patients treated with the device.
Duodenoscopes are used in over half a million procedures every year in the U.S. to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions.
Traditionally, duodenoscopes have been made to be used on multiple patients and were required to be cleaned and disinfected between uses to reduce potential for infections spreading between patients.
However, because the devices have many small working parts that are hard to clean, hundreds of patients were still getting infected, which prompted the FDA to issue a safety communication in August recommending device manufacturers transition to either partially or fully disposable duodenoscope designs.
Boston Scientific’s fully disposable duodenoscope, called the EXALT Model D, eliminates the risk of infection spreading between patients.
Read the full news release here.
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