FDA Looking into Reports of Infections, Contaminations of Reprocessed Urological Endoscopes
The FDA announced that it is investigating a large number of medical device reports (MDRs) of infection and contamination issues with reprocessed urological endoscopes.
The agency said that it has received more than 450 MDRs since 2017 describing patient infections that arose post procedure or possible contamination issues associated with reprocessing of the devices.
Reports that named the device manufacturer cited either Olympus or Karl Storz, the agency said, but it noted that it has not concluded that the safety issues are limited to a particular devicemaker or that any specific manufacturer or product lines’ devices hold a greater risk than others.
According to the FDA, some reports indicate possible inadequate reprocessing or maintenance issues, such as devices that failed leak testing, as a potential cause. It is also evaluating other potential issues, such as reprocessing instructions in the labeling and device design. The agency believes that the risk of infection from the devices is low but it is still in the early stages of its investigation.