By Betsy Todd, clinical editor, MPH, RN, CIC
Photo © Life in View/Science Source.
Many time-saving clinical technologies are available today that were unheard of at the start of my nursing career. Have we always given careful thought to how this technology is applied? A controversy about the safe use of point-of-care (POC) blood glucose meters (BGMs) in the ICU is a case in point.
Quick, minimally invasive bedside blood glucose monitoring has become the standard of care in hospitals and nursing homes. Interestingly, though, the original FDA approval of POC BGMs was for at-home use only. But the agency waived any restrictions on inpatient use, as long as staff performing the tests were properly trained and the patients were not critically ill. The use of BGMs in critically ill patients is considered “off label.”
Early in 2014, the FDA proposed new regulatory requirements for BGM use in hospitals. Apparently in response to the FDA’s proposal, the Centers for Medicare and Medicaid Services then issued a memorandum of intent to cite and even fine hospitals for the off-label use of BGMs in critical care. A huge outcry from clinicians ensued.
Is the use of point-of-care blood glucose monitors at the bedside less accurate in medically unstable patients? If we track blood glucose as we once did—via blood draws rather than fingersticks, with processing in the central chemistry lab—would this compromise treatment? Learn more about this controversy and about where the regulatory issue stands in this month’s article, “Blood Glucose Meters in ICUs“ (free access until May 6).
Many thanks for sharing these specific concerns. They seem to be the kinds of questions that the FDA would like answered before approving point-of-care BGMs for critical care use.
I am concerned that nurses are using a device that is considered off-label by the FDA, but is written policy in their ICUs. When strict glycemic control of surgical patients via insulin drip requiring hourly monitoring of blood glucose using BGMs began in my unit, I had concerns about the accuracy in relation to the coverage. Is the error range of the machine small enough to manage strict control? How accurate is a finger stick sample on a norepinephrine drip, or a patient with edema. Is it injurious to stick fingers every hour for many days? Is using blood from arterial lines accurate compared to capillary blood? I never got answers. I honestly did not know the status of the BGMs’ use in critical care. We all followed the policy of the hospital, did the calibration checks and followed the insulin coverage orders. Before we lobby for the FDA and CMS to change their policy, I think we should demand that research be done to guarantee the safety of the devices and strict guidelines on how and where they can be safely used established.