At a recent public meeting the FDA acknowledged that there are some 510(k) cleared BG meters and strips that do not meet the accuracy standards at which they were approved. There is no clear course of action to insure people with diabetes (PWD) are using blood glucose testing strips that meet regulatory requirements.
For PWD using insulin, meters are the tool used to regulate insulin dosing. Patients using meters that fail to meet accuracy standards increase the risk of overdosing on insulin. Hypoglycemia can result. Underdosing can result in hyperglycemia and even diabetic ketoacidosis.
In addition to acute adverse health outcomes, acceleration of long-term complications may result from inaccurate meters. This will result in higher medical cost to providers and lower quality of life and shortened life spans for patients.
The Centers for Medicare & Medicaid Services (CMS) auctions establish the price of test strips for Medicare and Medicaid patients. In turn, these prices impact private insurers’ reimbursement rates. These auctions are based on FDA 510k approved systems. Lower quality, less costly strips are likely to win these auctions, but there is no mechanism between FDA and CMS to maintain the quality of strips in the market.
It appears that foreign manufacturers are selling substandard strips to US consumers.
Success of the StripSafely campaign and lessons learned in bringing this issue to light may help future efforts to address other diabetes related public health issues, like pumps being part of CMS health guidelines for older Americans.
Every PWD should call for:
- Ongoing testing of BG strips to assure compliance with regulatory accuracy standards.
- Quality assurance on strips acquired through the distribution channels people use.
- Acknowledgement that the accuracy of strips is a public health and safety issue.
- Standards for accuracy of all strips sold in the USA improved to the latest ISO standards.
- FDA and Congressional consideration of the adverse effects that can come from meter inaccuracy.
- The creation of a process for CMS competitive bidding that consider the quality of what they are buying – not just price.
- Better standards than those created in 2003.