Image showing intravenous drip machine in a hospital room

Guidelines for the calibration of drug delivery devices and infusion device analysers

<p>New EURAMET guide developed within EMPIR project on metrology for drug delivery</p>

New EURAMET guide developed within EMPIR project on metrology for drug delivery

The project

Infusion therapy is used globally to treat numerous diseases and is one of the most commonly used forms of therapy in health care. Treatment of patients demand on the delivery of medication or fluids intravenously and for safety and accuracy infusion therapy is used with drug delivery devices. Drug delivery devices are one of the standard treatment modalities in and out of hospitals.

Completed EMPIR project Metrology for drug delivery (18HLT08, MeDDII) developed calibration methods to enable traceable flow rate measurements.

It also:

  • investigated fast-changing flow rates
  • explored the physical properties of mixtures of liquids and occlusion (blockage) phenomena in multi-infusion devices that administer more than one substance directly into the veins of patients over one access point
  • expanded the metrological infrastructure for flow rate measurements

A better understanding of the causes of dosage errors will lead to increased accuracy and fewer errors. Lives will be saved by uptake of traceable calibrations of both low and ultra-low flow infusion devices, especially for multi-infusion systems.

The guide

The new EURAMET Calibration Guideline No. 27 - Guidelines for the Calibration of Drug Delivery Devices and Infusion Device Analysers was published recently.

The guide was developed within the EMPIR project and in cooperation with members of the EURAMET Technical Committee for Flow (TC-F).

This document provides guidance for the calibration of drug delivery devices (DDD) and Infusion Device Analysers (IDA), normally used by hospitals, and accredited laboratories to verify the accuracy of the DDD and IDA related to the quantities: flow rate, volume (bolus) and occlusion pressure. The guide aims to harmonise the general procedures used by organisations to calibrate these instruments in their laboratories or hospitals. Several calibration methods and uncertainty calculation examples are presented.

Project coordinator Elsa Batista from IPQ said

‘The EURAMET calibration guide 27 resulting from Project MeDD is indeed a significant contribution to the metrological community and end users. By harmonising calibration procedures for various drug delivery devices, this guide enhances flow measurement accuracy and traceability in medical instruments. Its unique guidelines play a crucial role in improving health domain standards.’

This EMPIR project is co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States


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