Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy SCOPE The FDA has become aware of performance problems associated with point of care (POC) Prothrombin Time (PT)/International Normalized Ratio

The FDA has become aware of performance problems associated with point of care (POC) Prothrombin Time (PT)/International Normalized Ratio (INR) devices that raise patient safety concerns. Numerous reports of serious adverse events for POC PT/INR devices have been submitted to the FDA. The FDA’s postmarket analysis of these reports indicates that the adverse events appear to be linked to inaccurate performance of POC PT/INR devices in both home-use (self-testing) and professional healthcare settings. The accuracy, reliability, result reporting, and device usability of the PT/INR devices appear to have led to erroneous patient INR results. Therefore, the FDA is addressing the scientific and regulatory challenges associated with POC PT/INR devices’ safety and effectiveness in a public workshop at the White Oak Campus, Silver Spring, Maryland on January 25, 2016.