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Representations to standards-making organisations scale up the benefits of metrological traceability developed in EURAMET drug delivery projects

The case study Valid calibration of infusion pumps is the latest example of EURAMET support for standardisation in action, describing effective influencing of standardisation — in this case demonstrating a clear potential to save lives in the pressurised environment of hospital intensive care units.

Leveraging methods devised in the EMRP project Metrology for drug delivery (HLT07, MeDD), the EMPIR project Standards and e-learning course to maximise the uptake of infusion and calibration best practices (15SIP03, InfusionUptake) targeted revisions of standards used by manufacturers to guide on the maintenance of precise and accurate drug delivery devices in clinical practice. Both collaborative projects were part of EURAMET’s European Metrology Research Programmes (EMRP and EMPIR).

The project ‘InfusionUptake’ recently influenced the delivery of a major milestone towards its objective of convincing the most influential standards committee to incorporate robust flow metrology and calibration procedures, now expected in a scheduled revision of the International Electrotechnical Commission (IEC) standard for safety and performance of infusion pumps and controllers. 

As described in a previous case study, the project already successfully advocated for Calibration best practices to be included in standards for power-driven syringe pumps, as published by International Standards Organisation, including concepts of measurement uncertainty referencing EURAMET Calibration Guide 19 ‘Guidelines on the Determination of Uncertainty in Gravimetric Volume Calibration’.

Representations on committees of both standards bodies, combined with effective collaboration with manufacturers, resulted in, for the first time, the inclusion of metrology best practices in the important linked standards.

The route to impact for IEC 60601-2-24 was far from smooth, however. Delays necessitated a change of focus to another standard, then in revision. Leadership by experts of the Association for the Advancement of Medical Instrumentation (AAMI) Infusion Device Committee, and representations supported by the follow-on EMPIR project Metrology for drug delivery (18HLT08, MeDDII), led to state-of-the-art flow metrology being adopted in the widely-used AAMI TIR 101 standard, that the relevant IEC technical committee decided to use as the basis for flow metrology requirements in a planned revision of IEC 60601-2-24.

Awareness of benefits of flow metrology and device calibration procedures raised with standards makers

Infusion pumps provide measured dosing of many drug therapies for patients, including lifesaving or life-sustaining medications. Such pumps deliver medications at programmed rates, but incorrect doses can occur, meaning maintaining accurate and precise control of flow rates is critical for patient safety, not least as the use of infusion pumps is so widescale. About 80 - 90 % of hospitalised patients in the UK receive intravenous therapy in this way.

The International Electrotechnical Commission standard IEC 60601-2-24: 2012 guides manufacturers, laboratories, and hospitals on how to test for safety and performance of these devices, but causes of flow measurement errors or the need for robust calibration procedures had not been fully addressed.

In the meantime, awareness of the dangers became more widespread, partly due to the earlier MeDD project, but at the time of a scheduled review of the standard near the start of ‘InfusionUptake’ the relevant IEC technical committee lacked expertise in flow metrology solutions.

Prioritising flow measurement performance of infusion pumps in AAMI TIR 101

The ‘InfusionUptake’ project team presented evidence to the IEC committee to support the adoption of metrology best practices in IEC 60601-2-24, but delays prompted involvement in an initiative by the AAMI Infusion Device Committee, that prioritised amendment of its standard Technical Information Report (TIR) 101: Fluid delivery performance testing for infusion pumps, that could also be used as the basis of flow measurement requirements of IEC 60601-2-24.

Elsa Batista, Head of Volume and Flow Laboratory of the Portuguese Institute for Quality, and coordinator of ‘MeDDII’ project was invited to join the relevant IEC technical committee (TC62) and later the AAMI TIR 101 revision committee. Her presence in IEC TC62/MT23 in the January 2020 meeting in Washington DC led to the acceptance of all fifteen comments developed by ‘InfusionUptake’ for IEC 60601-2-24, as well as many others arising from ‘MeDDII’. Overall, about 90 % of comments made were accepted.

The third edition of IEC 60601-2-24 is scheduled for publication in 2023.

The AAMI standard TIR 101:2021 was developed during 2020 and 2021, and published in October 2021, including valid definitions of fluid delivery performance test methods for all infusion pump use conditions. This standard provides clinically relevant performance data, including reference to EURAMET’s Calibration Guide No. 19. The ‘MeDDII project contributed significantly to the metrological information and technical requirements added to the document.

Importance of metrology and standardisation in healthcare

According to Menne Schakel, coordinator of ‘InfusionUptake’,

“These two case studies show the need for metrology and standardisation to deliver correct drug doses to patients in hospitals”.

While the ‘InfusionUptake’ project was instrumental to delivering these impacts, ‘MeDDII’ tipped the earlier project’s outstanding objective over the line.

MedDDII coordinator Elsa Batista added,

“The MeDDII consortium and the medical world recognise the importance of the AAMI TIR101 document, which is why we engaged with AAMI. That led to an invitation to help revise the document. Our technical comments were well received and are incorporated in the new version.”

“TIR101 includes many inputs from InfusionUptake and MeDDII, including several EURAMET guides referenced in its bibliography. This document will be the basis of a revision of IEC 60601-2-24 regarding flow measurement, which is ongoing. Overall, this was a very good accomplishment for the flow metrology world.”

These EMPIR projects are co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States.

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