For years, the FDA has warned the industry of the risks of improperly cleaned and reusable endoscopes designed to visualize the stomach and intestines. Now, it’s doing the same with urological scopes following the reports of patient deaths from bacterial infections outside the U.S.
The agency said it is investigating “numerous medical device reports” describing contamination issues and the patient-to-patient transfer of pathogens from devices used to view and access the urinary tract, bladder and kidneys, including cystoscopes, ureteroscopes and cystourethroscopes.
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