FDA meeting: Clinical accuracy requirements for point of care blood glucose meters.
نویسنده
چکیده
Author Affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Silver Spring, Maryland
منابع مشابه
New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting, October 28, 2011.
Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October...
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System accuracy requirements for blood glucose (BG) meters (BGMs) are defined in standards (1) or guidance documents (2). In 2013, International Organization for Standardization (ISO) 15197:2013 stated that BGMs are acceptably accurate if $95% of their measurement results are found within 615 mg/dL (0.83 mmol/L) or 615% (whichever is larger) of reference results (1). The 2014 U.S. Food and Drug...
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BACKGROUND Accuracy standards of blood glucose (BG) meters are currently under review. Revised standards are expected to tighten accuracy requirements. Regarding clinical and financial impact of BG meter accuracy, very little data are available. The aim of this study was to analyze potential cost savings related to higher accuracy of glucose meters in Germany. METHODS As a model for calculati...
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BACKGROUND The accuracy of point-of-care blood glucose (BG) meters is important for the detection of dysglycemia, calculation of insulin doses, and the calibration of continuous glucose monitors. The objective of this study was to compare the accuracy of commercially available glucose meters in a challenging laboratory study using samples with a wide range of reference BG and hemoglobin values....
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Patients managed in the intensive care units (ICUs) and general wards of the hospital experience a high incidence of hyperglycemia, hypoglycemia, and glycemic variability, despite significant hospital resources devoted to glucose control. Optimized glucose meters and monitoring systems are required to improve the safety and efficacy of insulin delivery and glucose control in the hospital. Safe ...
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ورودعنوان ژورنال:
- Journal of diabetes science and technology
دوره 4 2 شماره
صفحات -
تاریخ انتشار 2010