Low flow measurement for infusion pumps: implementation and uncertainty determination of the normalized method

Intravenous drug delivery is a standard practice in hospitalized patients. As the blood concentration reached depends directly on infusion rate, it is important to use safe devices that guarantee output accuracy. In pediatric intensive care units, low infusion rates (i.e. lower than 10.0 ml/h) are frequently used. Thus, it would be necessary to use control programs to search for deviations at this flow range. We describe the implementation of a gravimetric method to test infusion pumps in low flow delivery. The procedure recommended by the ISO/IEC 60601-2-24 standard was used being a reasonable option among the methods frequently used in hospitals, such as infusion pumps analyzers and volumetric cylinders. The main uncertainty sources affecting this method are revised and a numeric and graphic uncertainty analysis is presented in order to show its dependence on flow. Additionally, the obtained uncertainties are compared to those presented by an automatic flow analyzer. Finally, the results of a series of tests performed on a syringe infusion pump operating at low rates are shown.