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FDA Clears Glucose Monitoring System for Use in Critical Care Units
The FDA has approved a new indication for the Nova StatStrip Glucose Hospital Meter System (Nova Biomedical), extending its use to hospitalized critically ill patients. This is the first blood glucose monitoring system (BGMS) approved for use in these patients.
BGMSs, also called blood 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.
The Nova StatStrip Glucose Hospital Meter System is the first FDA-cleared device specifically indicated for use in all types of hospital patients, including critically ill patients.
Users of BGMSs with manufacturer instructions that do not allow use with critically ill hospital patients would be subject to 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 BGMSs worked in that patient population.
The FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk of false results, and granted the device with a "clearance waived” test system status under the CLIA. This waived status allows a 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 also allows hospital labs to safely provide blood glucose monitoring to their critically ill patients without having to meet the CLIA requirements for high-complexity testing.
The FDA originally cleared the Nova StatStrip Glucose Hospital Meter System in April 2006 for use in hospitals as an aid in monitoring 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.
The new 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, neurologic, obstetric, gynecologic, gastroenterologic, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery.
Data supporting this clearance included a study of more than 1,650 patients with a range of medical conditions. These patients were taking various medications and were being treated in a variety of hospital departments, including cardiac, emergency intensive care, and surgical. The results showed agreement in blood glucose results compared with a laboratory glucose analyzer in all patient types tested.
Source: FDA; September 24, 2014.