NCHR Testimony at 2016 FDA Workshop on Point of Care Devices for Monitoring Warfarin Therapy

Testimony of Dr. Jay G. Ronquillo
FDA Public Workshop on Point of Care Devices for Monitoring Warfarin Therapy

Thank you very much for the opportunity to speak today.  My name is Dr. Jay Ronquillo and I am speaking on behalf of the National Center for Health Research.  I am a physician who trained at Massachusetts General Hospital, have two engineering degrees from Cornell, a Master of Public Health from Harvard, and a master’s in biomedical informatics from Harvard Medical School.  These are the perspectives I bring with me today.  Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policy makers.  We do not accept funding from the drug or medical device industry and I have no conflicts of interest.

Point of care PT/INR devices have the potential to improve the quality and efficiency of care for patients at risk for dangerous blood clots and related complications.  These devices are widely used but we do not have adequate data to make informed decisions about their safety and effectiveness.

We know that different medical, clinical, environmental, and genetic factors can affect the accuracy of results.  We need a clear understanding of how these various factors affect device readings.  Device manufacturers must be responsible for factoring the heterogeneous backgrounds and behavior of all potential users into the design, development, and implementation of these devices.  They have not yet done so.

Patients and providers depend on these devices. We recommend providing detailed data regarding all performance measures used, comparison studies performed, and other device-specific details that could directly affect clinical decision making.

Point of care PT/INR devices are currently classified as moderate risk (Class II) devices, cleared through the 510(k) process.  But they have been involved in moderate and even high-risk recalls, such as the Alere device used in the ROCKET AF clinical trial that led to approval of Xarelto.  As everyone knows, the use of INRatio in that study has raised questions about the comparative safety of Xarelto. This shows how device malfunctions no longer affect just single users, but directly influence approval decisions for any new drug being compared to warfarin.  In light of these potential risks to hundreds, thousands, or possibly even millions of patients, we strongly recommend that devices like INRatio be classified as a Class III device and reviewed through the PMA process.  Meanwhile, it should not be sold.

In summary, point of care PT/INR devices represent an increasingly important part of the healthcare landscape.  Transparent and robust design, performance studies, and clear data supporting safety and effectiveness are required to avoid device problems that could have wide-reaching consequences for patients and public health.  The only way to gather such data is through a rigorous PMA process.

Thank you again for the opportunity to speak today and for consideration of our views.