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Representations to standards-making organisations scale up the benefits of metrological traceability

The case study Valid calibration of infusion pumps is the most recent example of EURAMET support for standardising in action, describing effective influencing of standardisation — in this case, demonstrating a definite potential to save lives in the high-pressure setting of hospital intensive care units.

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

The ‘InfusionUptake’ project recently influenced the delivery of a major milestone toward its goal of persuading the most powerful standards committee to include robust flow metrology and calibration procedures in a scheduled revision of the International Electrotechnical Commission (IEC) standard for infusion pump and controller safety and performance.   

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

For the first time, representation on committees of both standards organisations, together with effective communication with manufacturers, resulted in the incorporation of metrology best practises in significant connected standards for the first time.

IEC 60601-2-24, on the other hand, had a bumpy road to adoption. Due to the delays, the focus was shifted to another standard, which was then under revision. State-of-the-art flow metrology was adopted in the widely-used AAMI TIR 101 standard, which the relevant IEC technical committee decided to use as the basis for flow metrology requirements in a planned revision of IEC 60601-2-24, thanks to the leadership of experts from the Association for the Advancement of Medical Instrumentation (AAMI) Infusion Device Committee and representations from the follow-on EMPIR project Metrology for drug delivery (18HLT08, MeDDII).

The benefits of flow metrology and device calibration methods have been brought to the attention of standard-setters.

Many therapeutic therapy, including life-saving and life-sustaining drugs, are delivered to patients using infusion pumps, which allow for precise dosing. Because infusion pumps distribute medications at predetermined rates, but wrong doses might occur, maintaining accurate and precise flow rate control is crucial for patient safety, especially given the widespread usage of infusion pumps. In the United Kingdom, approximately 80-90 percent of hospitalised patients receive intravenous therapy in this manner.

The International Electrotechnical Commission standard IEC 60601-2-24: 2012 instructs manufacturers, laboratories, and hospitals on how to test these devices for safety and performance, but it does not address the reasons of flow measurement mistakes or the necessity for thorough calibration processes.

In the interim, public awareness of the dangers grew, thanks in part to the earlier MeDD project, but the relevant IEC technical committee lacked experience in flow metrology solutions at the time of a scheduled revision of the standard around the commencement of ‘InfusionUptake.’

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.

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