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Contamination Rates Higher than Expected with Reusable Duodenoscopes

December 12, 2018

On December 10, 2018, the Food and Drug Administration (FDA) reported that bacterial contamination problems still persist with duodenoscopes after reprocessing, despite aggressive efforts by the agency and device manufacturers to eliminate these problems.

Interim results from the ongoing FDA-mandated postmarket surveillance studies show “higher than expected” contamination rates with reusable duodenoscopes. Up to 3% of properly collected samples tested positive for “low concern organisms”, indicating reprocessing failure. In addition, up to 3% of properly collected samples tested positive for “high concern” organisms (e.g., E. coli, and Pseudomonas aeruginosa) that can cause diseases.

Analyses are underway to identify the underlying causes of these results. In the meantime, the FDA is reminding endoscopy clinics that automated reprocessing is not sufficient; manual cleaning is still critical. The agency also emphasizes the importance of visual inspection for remaining debris or damage after reprocessing and again prior to use. Clinics are urged to implement a comprehensive quality control program for reprocessing duodenoscopes.

 

Food and Drug Administration (FDA). The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication. December 10, 2018. Available at: click here. Accessed December 11, 2018.