I wanted to do my part to comment to the FDA about their proposed changes in meter and strip regulations. The document is "Blood Glucose Test Systems for Over the Counter Use Draft Guidance".
One of the items being proposed to manufacturers--for voluntary compliance--is the following:
Section F (line 923) Calibration and External Control Material
"The use of external control solutions allows consumers to periodically check the accuracy of the SMBG device and test strip. In order to further promote the use of external control solutions by the user, you should include at least two levels of control materials to the customer with each test strip vial."
This led me to wonder how often anyone else uses control solution.
When I was new to testing, I learned "first-hand" (pun) about the inaccuracy of test strips. So I sent for some control solution. My memory is that the range of "accuracy" of the control solution was so broad that it was useless. I learn a lot more from retesting, or from doing two tests with one drop of blood, than I ever would using control solution. Am I wrong? Did I just not understand how to use it? Do others regularly use control solution?
Based only on my own experience, it seems like a waste--and a needless additional cost--for manufacturers to include control materials in each test strip vial. But what do others here think?
Thank you in advance for your input!