The FDA is warning healthcare providers of a potential infection risk linked to reprocessed urological endoscopes after receiving numerous reports of patient infections and contamination issues, the agency said April 1.
The FDA is still investigating the potential cause of these infections, but it said the infection risk is low.
Some reports cite inadequate reprocessing or maintenance issues as a potential cause of the infections. However, the agency is also evaluating potential issues with device design and reprocessing instructions.
The FDA recommends healthcare providers carefully follow the manufacturer's reprocessing instructions, avoid using damaged devices and schedule routine device inspections, among other actions to minimize infection risk.
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