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# Duodenoscopes’ Higher-than-expected Contamination Rates: FDA
- URL: https://www.fdaweb.com/duodenoscopes-higher-than-expected-contamination-rates-fda/
- Published: 2018-12-10T12:00:00.000Z
- Updated: 2026-09-15T00:49:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143003

FDA has issued a [safety communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm?ref=fdaweb.com) reporting on preliminary findings and providing important information to hospitals and health care providers who use and reprocess duodenoscopes. Interim results from studies ordered by the agency show “higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for more than 100 colony forming units of low concern organisms that are unlikely to cause serious infections (but an indication of a reprocessing failure) and an additional 3% of properly collected samples testing positive for ‘high concern’ organisms,” the safety alert says.

Duodenoscope manufacturers are currently conducting root cause analyses to better understand these preliminary culturing results, the agency says. Some factors that may contribute to device contamination include device damage and reprocessing errors. “Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing,” FDA says.

Additionally, the agency alert says that hospital and health care facilities that use duodenoscopes should meticulously follow manufacturer reprocessing instructions. “In addition, health care facilities should consider implementing supplemental reprocessing measures to reduce the risk of infection transmission, such as microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection,” it adds.