The FDA has granted a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized in order to monitor 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. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients. The FDA originally cleared the Nova StatStrip Glucose Hospital Meter System in April of 2006 for use in hospitals to help monitor the effectiveness of a diabetes control program, but not for use with critically ill patients. The device manufacturer submitted a new premarket submission to the FDA seeking clearance of the device with this new indication
Blood glucose glucose meters, are handheld devices that measure the amount of sugar (glucose) in blood by analyzing a small drop of blood that is placed on a test strip. After inserting the test strip into the device, the system displays a glucose level reading. Blood glucose measurements are used in the management of many patients in the hospital, including patients requiring insulin to manage blood sugar, and in the assessment of blood glucose levels in newborn babies.
According to the agency. the Nova StatStrip Glucose Hospital Meter System were found “simple to use and has a low risk for false results.” As a result it granted its extended use after waiving the 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, such as at a patient’s bedside, instead of requiring that the test be performed in a hospital lab (or other lab) that meets the CLIA requirements for high complexity testing. The CLIA waiver will also allow hospital labs to safely provide blood glucose monitoring to their critically ill patients without having to meet the significant CLIA requirements for high complexity testing.
“This device provides an important public health resource for critically ill hospitalized patients, who often have conditions or are taking medications that can cause incorrect blood glucose reading,” stated the director of the Office of In Vitro Diagnostics and Radiological Devices at the FDA’s Center for Devices and Radiological Health Alberto Gutierrez. “It is important for manufacturers of glucose meters