A New Standard for Monitors?
The Food and Drug Administration may raise its standards of accuracy for home blood glucose monitors, which millions of Americans rely on to manage their diabetes.
The FDA is pressing the International Organization for Standardization to adopt higher standards of accuracy for self-monitoring of blood glucose (SMBG) devices in light of recent technological advances, according to the New York Times.
"If the [international] standard for accuracy is not revised," according to a recent FDA report, "the agency would consider taking action to no longer recognize that part of the standard, and may instead recognize other (higher) performance standards for SMBG devices for management of diabetes."
FDA Commissioner Margaret Hamburg, MD, ordered that the report be written after the American Association of Clinical Endocrinologists complained in a May letter to her that "because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend on those meters is threatened."
The current international standard allows the monitoring devices to be wrong by as much as 20 percent. However, in its report, the FDA said that a review of the last 31 devices the agency has approved showed that about half of them would meet a tighter standard of accuracy within 15 percent.
Yet the FDA cautioned that even though SMBG devices may be somewhat inaccurate, their use has "a major positive impact" on people with diabetes. The agency also said it wanted to be careful not to increase the cost of self-monitoring so much that people with diabetes would test less frequently.
Finally, the FDA expressed concern that SMBG devices are being increasingly used in hospitals, even though they are not approved for diagnosing diabetes or for maintaining tight blood glucose control in a hospital setting.
For an American Diabetes Association guide to "Checking Your Blood Glucose," click here.




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