New FDA Requirements for Blood Glucose Meter Accuracy

David Mendosa Health Guide
  • The U.S. Food and Drug Administration is finally planning to require that our blood glucose meters will meet high standards of accuracy and precision.

    Dr. Margaret Hamburg, the new head of the FDA, recently wrote the American Association of Clinical Endocrinologists, or AACE, that the agency is pressing the International Organization for Standardization, or ISO, to set higher standards of accuracy and precision. "If the ISO standard for accuracy is not revised, the agency...may instead recognize other (higher) performance standards for SMBG [self monitoring blood glucose] devices for management of diabetes," according to a letter and attachment that she sent to AACE President Dr. Jeffrey Garber, and past presidents Drs. Daniel Duick and Richard Hellman. Dr. Hamburg's letter was a positive response to a formal request that the AACE made to the FDA in May.

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    Anyone who has ever tested his or her blood glucose for more than a month or so must be appalled at how inaccurate our blood glucose meters are. In the past ten years or so I must have written a dozen articles pointing out how bad they are.

    The FDA didn't tip its hand yet by putting in writing to the AACE just what new standards it plans to require. But the agency did drop a hint.

    About half of the last 31 blood glucose meters that the FDA approved for sale in the U.S. would meet performance standards within 10 mg/dl, when reading should be less than 75 mg/dl, and withing 15 mg/dl, when the reading should be above 75 mg/dl, according to the attachment Dr. Hamburg sent Dr.Garber. The FDA recognizes that when our blood glucose levels are below 75 mg/dl, accuracy becomes even more important.

    This morning's New York Times reported this big news for all of us with diabetes. Even though I subscribe to the print edition, I was out hiking in the Rockies today and haven't read the paper yet. Thanks to two of my favorite diabetes professionals, Certified Diabetes Educator Karen LaVine and Dr. Richard K. Bernstein, for emailing me the link to that article. This is such good news that I needed to write about it today.

Published On: July 19, 2009