FDA supports transition to fully disposable duodenoscopes, components
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The FDA has issued an updated safety communication supporting the transition to fully disposable duodenoscopes and those with disposable components.
According to data from 522 completed post-market surveillance studies, the use of removable components to facilitate cleaning leads to decreased contamination compared with older duodenoscope models (0.5% vs. 6%). Given cleaning concerns, the updated safety communication recommends the use of innovative scopes that facilitate or eliminate the need for reprocessing.
Although manufacturers no longer market fixed endcap duodenoscopes in the U.S., these models are still in use at many health care facilities and should be replaced by newer duodenoscopes.
Additional FDA recommendations for hospitals and endoscopy facilities include:
- Ensure staff are carefully following reprocessing instructions.
- Institute a quality control program that includes sampling, microbiological culturing and other monitoring methods.
- Consider additional reprocessing with sterilization or use of liquid chemical sterilant.
- Develop schedules for routine inspection and maintenance according to manufacturer instructions.
These updated guidelines build upon the April 2020 safety communication that similarly recommended the transition to newer duodenoscope models.
Reference:
U.S. Food and Drug Administration. The FDA is recommending transition to duodenoscopes with innovative designs to enhance safety: FDA safety communication. Available at: https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication. Published April 5, 2022. Accessed: April 6, 2022.
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U.S. Food and Drug Administration. Use duodenoscopes with innovative designs to enhance safety: FDA safety communication. Available at: https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication. Published April 5, 2022. Accessed: April 6, 2022.
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