The Food and Drug Administration yesterday alerted health care providers to the risk of infections associated with reprocessed urological endoscopes, used to view and access the urinary tract, citing over 450 medical device reports since 2017 describing post-procedure patient infections or other possible contamination.
Reports noting a device manufacturer cited either Olympus Corporation or Karl Storz, FDA said.
“We are very concerned about the three reported deaths—outside of the United States—associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “While some reports indicate the potential causes could be inadequate reprocessing or device maintenance issues, we’re also evaluating other possibilities, including device design or the reprocessing instructions in the labeling. Although we believe that the risk of infection is low based on available data, we’re reminding health care providers how important it is to follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components.”