With its warning of risks associated with urological endoscopes, FDA’s focus expands to a second category of endoscopic devices that are used in multiple patients and disinfected between procedures. Its earlier concerns about contaminated duodenoscopes, which also have been linked to patient deaths, led the agency to recommend that hospitals transition to newer versions of the devices that can be reprocessed more effectively or that eliminate the need for reprocessing.
FDA is “very concerned” about the three deaths from bacterial infection tied to urological endoscopes, Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement. The devices are used in diagnostic and therapeutic procedures in the urinary tract.
