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Regulatory Focus™ > News Articles > 2020 > 1 > FDA Calls for Switch to New Duodenoscopes

FDA Calls for Switch to New Duodenoscopes

Posted 15 January 2020 | By Michael Mezher 

FDA Calls for Switch to New Duodenoscopes

After clearing the first single-use duodenoscope last month, the US Food and Drug Administration (FDA) on Wednesday called on hospitals and healthcare providers to transition away from older, infection-prone duodenoscopes to newer models with disposable designs.
Over the last three years, FDA has also cleared duodenoscopes with single-use components such as end caps and elevator pieces, aimed at reducing the risk of infection, and other companies have said they are working to develop their own single-use duodenoscopes.
While acknowledging that such a transition will take time, FDA says it will “continue to work with manufacturers to increase the supply of disposable cap duodenoscopes” and promote the development of new duodenoscopes with innovative designs that will reduce the risk of infection.
FDA also said it is still working to address challenges related to the reprocessing of traditional duodenoscopes that are still in use.
The call comes more than six years after FDA was first notified of carbapenem-resistant enterobacteriaceae (CRE) outbreaks at multiple hospitals by the Centers for Disease Control and Prevention because of the devices.
In the years since, FDA has taken a number of actions resulting from its investigation into the devices, including requiring a Section 522 postmarking study for the devices; warning the three largest duodenoscope manufacturers over cleaning validation and failing to adhere to postmarketing study requirements; recalling a device commonly used to clean duodenoscopes; and urging industry to move to less risky designs.
While industry has heeded FDA’s call to develop partially and fully disposable duodenoscopes, some researchers have questioned how the transition will affect health care spending and whether new designs and reprocessing methods for reusable duodenoscopes could be sufficient to reduce infection risks.

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