Earlier this year, the U.S. Federal Drug Administration began ruminating over the idea of changing the way that blood glucose monitors are used and classified. Needless to say, it created quite a stir among members of the healthcare community. Many people supported portions of the non-binding guidelines and vehemently opposed others. So what’s all the controversy about?
Basically, the government is proposing that blood glucose monitors be held to certain standards based on where they are designed to be used and who the user is expected to be. This could prove to be problematic for acute care settings and others that currently use select blood glucose monitors to perform beside care.
How so? Well, if the new guidelines become standard rule, those blood glucose monitors may need to be replaced along with the venues’ infection control related policies on such devices. In addition, such segregation could also potentially cause discrepancies in readings depending on which blood glucose monitors are being utilized.
Furthermore, home users may see their blood glucose monitor needs change as well. That’s because the proposed guidelines include potential alterations to sample size standards, accuracy standards and disinfection procedures. For those that want to read the projected guidelines for themselves, there are copies of both the bedside and in-home use drafts available through the FDA’s website.
As we mentioned previously, these wished-for standards are still being debated. So at this point, the healthcare community and consumers are not required to follow them just yet. Nonetheless, it would be wise for diabetics to talk to their healthcare providers about what it may mean, specifically, for their own diabetes management routines. Depending on the given situation, physicians may recommend that diabetics make the switch to new blood glucose monitors sooner, rather than later.
For more information about blood glucose monitors, including how the various ones on the market today stack up against one another, please contact us.