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POC Screening for Coumadin Effect

From John McClure: We have been approached by our neurology and ER services to establish point of care prothrombin time/international normalized ratio (PT/INR) testing to assess for Coumadin effect prior to initiating thrombolytic therapy in stroke patients. One of our point of care (POC) coordinators has pointed out that the devices are FDA approved for monitoring patients on Coumadin. Does this difference create a potential regulatory problem? Can we use the POC device without running afoul of the FDA approval?

Hello, and thank you for your question. All POC devices are currently cleared for monitoring Coumadin. Screening for Coumadin effect would not be an off-label application, you should be able to use your device for this purpose. Geo.

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