National Diabetes Volunteer Leadership Council (NDVLC) Urges FDA to Enforce Stringent Accuracy Standards for Blood Glucose Monitoring Systems
BETHESDA, Md., Sept. 9, 2013 /PRNewswire-USNewswire/ — Today, representatives from the U.S. Food and Drug Administration (FDA), industry and the diabetes advocacy community will convene at a Diabetes Technology Society meeting in Bethesda, Md., to discuss possible solutions for verifying the accuracy of self-monitoring blood glucose (SMBG) systems. The following statement can be attributed to Larry Ellingson, spokesperson for the National Diabetes Volunteer Leadership Council (NDVLC) and past chair of the American Diabetes Association board (2005):
“On behalf of the NDVLC and the 25.8 million Americans living with diabetes, we applaud the efforts of the Diabetes Technology Society to examine the very serious and potentially life-threatening issue of inaccurate SMBG systems. Patients with diabetes rely on these systems to guide the decisions they make multiple times a day about their disease management, and it is crucial that the information is accurate to avoid putting their health at risk.
We look forward to hearing from the FDA today on ways they plan to enforce accuracy standards equally among all SMBG manufacturers. It is simply unacceptable that up to 45 percent of the systems marketed globally to patients with diabetes do not meet the minimum accuracy requirements post-approval and that some manufacturers have failed to provide the FDA with the requisite medical device reporting (MDR) of adverse events.
The NDVLC encourages the FDA to closely examine and enforce the approval and testing processes for these devices to create a safer environment for patients living with diabetes. The FDA should use their existing authority to ensure the health and safety of patients with diabetes while considering any new approval standards, validation, and continuous monitoring of SMBG systems post-clearance. Only once we have applied these higher standards to new and existing products can we ensure that diabetes patients across the country have access to the safe meters that they deserve. In the interim, products that fail to meet standards should not be commercially available.”
The meeting, “Verifying the Performance of Blood Glucose Monitors Following FDA Clearance,” will be hosted September 9 at the Hyatt Regency hotel in Bethesda, Md., beginning at 8:30 a.m. EDT. For more information, visit www.diabetestechnology.org/bgm.
About National Diabetes Volunteer Leadership Council
The National Diabetes Volunteer Leadership Council is an organization comprised of former chairs of the board and past officers of the American Diabetes Association who are committed to ensuring the well-being of diabetes patients across the country.
SOURCE National Diabetes Volunteer Leadership Council