Posted by Sten Westgard, MS
Back in 2010, FDA hosted a series of public meetings about problems with glucose meters. 4 years later, we're beginning to see significant repercussions.
The New York State Department of Health has sent a letter to Laboratoy Directors informing them that many common uses of glucose meters will henceforth be considered "off-label":
"To date, FDA has approved (or cleared) glucose meters for the quantitative
measurement of whole blood glucose for use by healthcare professionals or lay users
as an aid in monitoring the effectiveness of a diabetes control program....
"The FDA has reminded clinical laboratory regulatory agencies that “Intended Use” in the
package insert or product manual does not include diagnosis of, or screening for,
diabetes. Other off-label uses of glucose meters include the monitoring of glycemic
control of non-diabetic patients in hospitals; use on critically ill patients; and use in
health fairs and other community events to screen the public for diabetes.
"Laboratories that use glucose meters for purposes or in populations beyond the
Intended Use in the package insert or device manual are considered to be engaging in
off-label use. The Centers for Medicare and Medicaid Services (CMS) have instructed
us that the laboratory must be informed that in the event of such off-label use, the
glucose meter defaults to high complexity and the laboratory must meet the CLIA
requirements for high complexity testing. In New York State, this means that the testing
would require a New York State clinical laboratory permit in the category of Clinical
Chemistry and only personnel licensed by the New York State Education Department
would be eligible to perform the testing. In addition, the laboratory would be required to
fully establish the analytic and clinical performance specifications (i.e. validate) of all
such devices for any change from Intended Use in their patient population. Until such
requirements have been met, the use of glucose meters in health fairs, other community screening events, and/or critical care settings must be discontinued."
If a glucose meter goes "off-label" - it is no longer a waived device, but instead it becomes HIGH COMPLEXITY, which requires many more studies before it can be validated for use.
This is a very big deal, but since NY is one of the few states that has its own regulations, most other labs will be waiting to see what happens with CMS regulations, accreditation guidelines, etc.
One way to look at this: in the four year gap, manufacturers had the opportunity to improve analytical performance of glucose meters, but obviously chose not to. This is the consequence.
Stay tuned, this will be a bumpy ride!