Glucose Monitoring System Cleared for Hospital Critical Care Units

A blood glucose monitoring system (BGMS) has been cleared and its use extended to critically ill patients who have been hospitalized.

Users of BGMS with manufacturer instructions that do not provide for use with critically ill hospital patients would be subject to the high complexity testing requirements under the Clinical Laboratory Improvement Amendments (CLIA) if such systems were to be used in the critically ill hospital population. Those requirements include the validation of how well the BGMS worked in that patient population.

The US Food and Drug Administration (FDA; Silver Springs, MD, USA) determined that the Nova StatStrip Glucose Hospital Meter System (Nova Biomedical, Waltham, MA, USA) is simple to use and has a low risk for false results, and granted it with the clearance “waived” test system status under CLIA. This waived status will allow a broad variety of health care professionals, such as nurses and technicians, to perform the test at the point-of-care instead of requiring that the test be performed in a hospital laboratory or other laboratory that meets the CLIA requirements for high complexity testing. The CLIA waiver will also allow hospital laboratories to safely provide blood glucose monitoring to their critically ill patients without having to meet the significant CLIA requirements for high complexity testing.

Data supporting this clearance included a study of more than 1,650 patients with a range of medical conditions, taking various medications, and being treated in a variety of hospital departments, such as cardiac, emergency intensive care, and surgical. Results showed agreement in blood glucose results compared to a comparator laboratory glucose analyzer in all patients types tested. The clearance is for indications that include using arterial or venous whole blood from patients in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery.

Related Links:
US Food and Drug Administration 
Nova Biomedical