Why You Should Worry About the Accuracy of Test Strips

True or false: The FDA guarantees the safety and accuracy of blood glucose test strips currently on the market.

Answer: False. If I may quote from the website of StripSafely, a patient-run effort to ensure test strip quality, “The FDA reviews test strips presented by manufacturers before the strips can be marketed but not after. Strips can and do vary after they are marketed. There is no post market review.”

Are you surprised? I certainly was. That’s why l attended last week’s summit led by David Klonoff of the Diabetes Technology Society in Bethesda, Maryland about a proposed post-market surveillance program for diabetes test strips. Klonoff is a clinical professor in the division of endocrinology and metabolism at UCSF; he founded the Diabetes Technology Society , which is a non-profit, non-governmental organization “committed to promoting development and use of technology in the fight against diabetes” in 2001.
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