FDA

FDA Investigating More than 450 MDRs Related to Endoscope Reprocessing

By MedTech Intelligence Staff
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FDA

The medical device reports describe both patient infections and other possible contamination issues.

Proper reprocessing of urological endoscopes is once again in the spotlight, as FDA announced that it is investigating medical device reports (MDR) that cite patient infections and contamination issues linked to reprocessed urological endoscopes. Between January 1, 2017 and February 20, 2021, the agency received more than 450 MDRs associated with this problem.

According to the FDA, Olympus Corp. and Karl Storz were named in the MDRs that cited the manufacturer. Olympus submitted three reports that involved a patient death due to a bacterial infection (this happened outside the United States).

“The FDA is investigating potential causes and contributing factors associated with reported infections and contamination issues from reprocessed urological endoscopes,” said CDRH Director Jeff Shuren, M.D in an FDA letter to healthcare providers. “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.”

The agency is reviewing the potential causes and contributing factors linked to the reported infections and contamination problems. This includes reprocessing methods, reprocessing labeling instructions and design of the device.

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