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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.
"The FDA takes these violations very seriously and will continue to monitor these firms to ensure they take appropriate corrective action," the agency said in a statement. "However, currently available information indicates that the benefits of these devices continue to outweigh the risks in appropriately selected patients."For more click here