FDA issues letters to makers of scopes linked to superbug outbreak

Manufacturers of medical devices linked to recent superbug outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements, the U.S. Food and Drug Administration said in warning letters to the companies released on Monday. The letters, sent on Aug. 12, cite Olympus Corp Pentax Medical and Fujifilm Holdings Corp with multiple violations found during inspections of their U.S. and foreign facilities. Violations range from not properly evaluating cleaning, sterilization and testing procedures to failure to report infections and other problems. Fujifilm and Pentax were also cited for violations in their marketing applications for the devices, known as duodenoscopes.