Infusion Pumps Calibration Methods

Nowadays, several types of infusion pumps are commonly used for drug delivery, such as syringe pumps and volumetric pumps. These instruments present different measuring features and capacities according to their use and therapeutic application.
In order to ensure the metrological traceability of these flow and volume measuring equipment it is necessary to use suitable calibration methods and standards.
Two different calibration methods can be used to determine the flow error of infusion pumps. One is the gravimetric method, considered as a primary method and commonly used by the National Metrology Institutes.
The other calibration method is a secondary method, which relies on an Infusion Device Analyser (IDA) and is typically used by the hospitals maintenance offices.
The gravimetric method is the most accurate one but the comparison method allows calibration of infusion pumps within the hospital facilities. In this work the two calibration methods are described in detail.
Also the two international research projects that allowed the development of these methods at the Volume and Flow Laboratory of the Portuguese institute for quality are explained.

Flow Rate, Infusion pumps, Calibration, Traceability

Elsa Batista has a master degree in Analytical Chemistry from the Faculty of Science of Lisbon University– Portugal, Lisbon in 2007 and a degree in Applied Chemistry from the Faculty of Science and Technology, FCT, NOVA University of Lisbon in 1999. She is the head of the volume laboratory of the Portuguese Institute for Quality since 1999. She is also the contact person and Chair of the Technical committee for flow of EURAMET.
Maria do Céu Ferreira holds a Ph.D. in industrial engineering from the Faculty of Science and Technology; FCT, NOVA University of Lisbon. Since 1994, she is Metrologist at the Metrology Department of the Portuguese Institute for Quality
(IPQ), having developed its activities in the areas of scientific and applied metrology, managing multi-disciplinary teams related
with standards and measurements. Since 2008, Maria is in charge at Legal Metrology as Quality Manager and Assessment
of the Metrological operations and verification bodies. Meanwhile, she founder and is responsible for the Portuguese Health Metrology committee, hosted by IPQ. Maria is a designated member of the Metrology Board of the Portuguese Engineers order and is Professor in the Faculty of Engineering at the Lusófona University of Lisbon. Maria is the Portuguese member of the International
Board of Experts of the International Organization of Legal Metrology and is an active member of OIML, WELMEC and ISO. Her research interests include all health metrological applications for ensuring traceability and new quality assured measurement methods.

IEC 60601-2-24:2012 Medical electrical equipment – Part 2-24: Particular requirements for the safety of infusion pumps and controllers.
Sectoral Comission on Health. (2018), Metrology in Health. Good Practices Guide, Part II-Chapter III Infusion Pumps. 1st edition. ISBN 978-972-763-172-8.
Instituto Português da Qualidade (2012), Vocabulário Internacional de Metrologia. 1ª Edição Luso-Brasileira. IPQ. ISBN 972763006.
Lucas, P., Klein, S.(2015), Metrology for drug deliver, y Biomedical Engineering, 60(4).
Bissig, H., Petter, H.T., Lucas, P., Batista, E., et al. (2015), Primary standards for measuring flow rates from 100 nl/min to 1 ml/min – gravimetric principle, Biomedical Engineering, 60(4).
ISO 7886 – 2 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use.
Batista, E., H Bissig, H., Petter, H.T., Lucas, P et al. (2015), Assessment of drug delivery devices, Biomedical Engineering, 60(4).
BIPM et al. (1995), Guide to the Expression of Uncertainty in Measurement (GUM), 2nd ed., International Organization for Standardization, Genève.
Batista, E., Godinho, I., Ferreira, M., Lucas, A.. (2017), Comparison of infusion pumps calibration methods, Measurement Science and Technology, 28 (12).