Statement by the American Diabetes Association on the Need for FDA Regulation of Blood Glucose Test Strips
July - 31 - 2013
Alexandria, VA (July 31, 2013) – The evolution of portable glucose meters and test strips over the past few decades has revolutionized diabetes management. By being able to test their blood glucose as frequently as needed, patients have been able to simultaneously improve their diabetes self-management and gain greater freedom in their daily schedules for meals and physical activity.
The availability of accurate blood glucose meters and test strips is critical to the success of diabetes self-management. Diabetes test strips must be manufactured to exacting standards, and they must be shipped and handled with care to assure that they remain capable of performing at their expected level of accuracy. Faulty or inaccurate equipment can not only lead to just poor diabetes self-management but to an acute medical crisis if a patient makes incorrect treatment decisions based on faulty data. A patient who administers additional insulin, based on a faulty test strip reading that indicates that their blood glucose level is high when it is actually low, runs the risk of acute hypoglycemia, which can lead to an impaired cognitive state, coma, and even death if left untreated.
The American Diabetes Association strongly endorses the Food and Drug Administration’s (FDA) oversight of test strip manufacturers, sales, and distribution to safeguard the quality and accuracy of the tools involved in diabetes self-management. The Association applauds the FDA’s requirements that all test strips meet existing FDA standards for medical devices, since those standards are designed specifically to require the greatest accuracy in readings when an error would place a patient’s health and life in danger. It is critical that FDA oversight extend beyond the initial pre-marketing approval to continual monitoring of the post-marketing product to assure that accuracy remains within established standards.