Approach to assess accuracy of syringe pumps in target-controlled infusion mode

Abstract

Target-controlled infusion (TCI) requires that the syringe pump accurately follows a volumetric profile calculated by the TCI controller, leading to the concentration setpoint actually being reached. Until now, no method for quantifying dosing accuracy in TCI mode has been published. We propose an adaptation to the test procedure described in IEC standard 60601-2-24 for quantifying syringe pump accuracy to measure the performance characteristics of TCI by amending the flow rate measurement with calculation of the resulting effect site concentration. In the proposed procedure, infusion rates in TCI models are measured for a number of test patient parameters covering the applicable range of age, height and weight for the underlying patient models. The same pharmacokinetic-dynamic (PK/PD) models as implemented on the pumps are used to calculate the actual effect site concentration using the “PKPD Tools for Excel” by Minto and Schnider (2009) [1]. An exemplary test case evaluation with simulated data is given to illustrate feasibility.