Posted by Sten Westgard, MS
Did the FDA Gaffe on Glucose Meters?
In January, the FDA released a Draft Set of Guidelines on Glucose Meters. As responses have flown in, it's become clear that most of the laboratory community is not happy with these newly proposed regulations. Since many of the responses are posted publicly, and other reactions have been made in press releases or media interviews, we've collected some of the key criticisms in one place.
What's wrong with the new FDA proposal on glucose meters? Labs, Professional organizations, and Manufacturers count the ways...
The Case for Better Glucose Meter Quality
The original motivation for the 2014 FDA Draft Guidelines for Glucose Devices came from a public conference in 2010 that the FDA held to hear concerns about the performance of meters. But since that open meeting, even more studies have been done that show there are real benefits, both clinical and financial, to having meters with higher quality. So while much of the recent discussions are criticisms of the proposed guidelines, we take a moment to marshal some evidence into a counter-argument. Yes, we realize much of these new changes will be an inconvenience and greater expense to labs and manufacturers, but if the ultimate result is a better class of devices, better care for patients, and less expense for healthcare systems, is this worth the trouble?
Why all the fuss about demanding more quality about glucose meters? What could be gained by better precision and accuracy?
Plus, a recap of the 21 things we've learned about the new Blood Glucose Meter regulations.
What target can glucose meters hit?
In all the discussion about the guidelines for glucose meters, it's helpful to take a reality check and actually review some of the performance data that's out there. Taking a recent 2014 study of 3 glucose meters, we can see that many devices can meet today's standard, but if the requirement does tighten, there will certainly be winners and losers. Also listed below are some of the previous Sigma-metric analyses we've done on glucose tests, both at the point of care and in the core laboratory.
Wisecheck, ACCU-CHEK Performa, and SD Glucolink: which meter hits the bull's-eye? Could they hit a smaller target if they had to?
Some of our past Sigma-metric glucose articles: