Former Chief Officer of ADA Blows Whistle on Substandard Diabetes Monitors
“In the decades I have worked in the field of diabetes, there have been few risks as clear and urgent as this one, action must be taken.” – Dr. Richard Kahn
Dr. Richard Kahn, a professor of medicine at the University of North Carolina and former chief scientific and medical officer of the American Diabetes Association, warns that substandard blood glucose monitors made available through Medicare’s competitive bidding program could cause “vulnerable citizens” to adjust their insulin according to the result of the monitor and “unknowingly risk hypoglycemia, hospitalization, or death.”
Medicare Bidding Program and Blood Glucose Monitors
- The bidding program was implemented by Centers of Medicare and Medicaid Services to reduce costs of durable products such as blood glucose monitors.
- Products from bidding are assumed to be of equal quality and accuracy.
- There is currently no FDA surveillance system to ensure quality of devices.
- During an FDA meeting it was openly acknowledged, with supportive data, that many of the monitors in the program did not meet FDA standards.
- Almost all problems lie with products from low cost manufacturers overseas.
- While the FDA has acknowledged the problem, these monitors are still commercially available.
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