FDA investigates urological endoscopes
The Food and Drug Administration (FDA) announced it is investigating reports of infections associated with reprocessed urological endoscopes. The FDA received more than 450 medical device reports (MDRs) describing post-procedure patient infections or other contamination issues associated with reprocessing urological endoscopes. Andersen’s EOGas 4 presents an FDA-cleared terminal sterilization option for the urological endoscopes under investigation, as well as significantly longer and smaller diameter scopes.