By Betsy Todd, clinical editor, MPH, RN, CIC
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. […]