ADA Calls on the FDA to Better Monitor Blood Glucose Meter and Test Strip Quality

On July 31, the ADA issued a statement on the importance of accurate blood glucose meters and test strips, calling for the FDA to continually monitor product quality and accuracy. Right now, following regulatory approval, the FDA does not assess strip or meter accuracy on a routine basis – this is an issue for patients, since there are concerns that some manufacturers’ strips are accurate enough for approval, but then quality declines over time. Additionally, all data given to the FDA by blood glucose monitoring companies is self-reported by the companies themselves, not independently assessed by an external organization or the FDA.

This announcement comes amid concern that the Center for Medicare and Medicaid Services (CMS) reimbursement cuts have begun to force people to use lower-priced and potentially lower-quality meters and strips. For more information on glucose test strip accuracy and how to get involved in this advocacy effort, see our Strip Safely article or visit StripSafely.com and write your Congresspeople and Senators. This has become a hot issue in recent months – an upcoming September 9 meeting in Bethesda, Maryland will discuss how the FDA should monitor strip quality and accuracy post-approval. -NL