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Recent Actions by the US Food and Drug Administration: Reducing the Risk of Infection from Reprocessed Duodenoscopes
Shanil P Haugen1, Ann Ferriter1, Jian Connell1
1United States Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Health Technology 3, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.
Gastrointestinal Endoscopy Clinics of North America
|September 6, 2020
Summary
Community engagement is crucial for reducing infection risks from reprocessed duodenoscopes. Collaboration enhances cleaning awareness, training, research, and facility-level quality improvement for safer patient outcomes.
Area of Science:
- Healthcare-associated infections
- Medical device reprocessing
- Patient safety
Background:
- Reprocessing of duodenoscopes presents challenges in infection control.
- Technological advancements alone are insufficient to mitigate infection risks.
Purpose of the Study:
- To highlight the importance of stakeholder collaboration in reducing duodenoscope-related infections.
- To outline key areas where community engagement can improve reprocessing practices.
Main Methods:
- Community engagement and stakeholder collaboration.
- Raising awareness and improving training.
- Identifying research priorities and developing quality improvement tools.
Main Results:
- A collaborative community can foster better understanding and implementation of cleaning protocols.
- Targeted research and practical tools can enhance reprocessing quality at healthcare facilities.
Conclusions:
- Multidisciplinary collaboration is essential for minimizing infection risks associated with reprocessed duodenoscopes.
- The Food and Drug Administration is committed to supporting community efforts in this critical area.
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