FDA MedWatch - Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers The FDA wants to raise awareness among health care providers, including those working in reprocessing units in health care facilities, about the risk of infections associated with reprocessed urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes, used for viewing and accessing the urinary tract. The FDA has received numerous Medical Device Reports (MDRs) which describe patient infections post procedure or other possible contamination issues associated with reprocessing these devices. The Letter to Health Care Providers includes important information about reprocessing methods including: Carefully following reprocessing methods according to the manufacturer's instructions. Recommendations for health care providers. Actions the FDA has taken to evaluate reports of infection and contamination associated with endoscopes and accessories used for accessing the urinary tract. Instructions for reporting problems with the devices. Questions? If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).

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