FDA warns of risks of urological endoscopes after 'numerous' reports of infection

The U.S. Food and Drug Administration warned healthcare providers of the risk of using reprocessed urological endoscopes after "numerous" reports of infection.

In a letter dated April 1, the FDA recommended that providers pay extra attention to manufacturer labeling and reprocessing instructions when cleaning and processing these devices to minimize the risk of infection. 

The FDA said it received more than 450 reports that described patient infection post-procedure and other possible contamination issues associated with reprocessing devices such as cystoscopes, ureteroscopes and cystourethroscopes. 

Some reports indicate possible inadequate reprocessing or maintenance issues, such as the device failing leak testing. The FDA believes the risk of infection is low. 

Manufacturers Olympus and Karl Storz were specifically named, but the FDA stressed that it had not determined that risks were greater with those companies' products than others.

You can find the FDA's detailed recommendations here.

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