Standards and e-learning course to maximise the uptake of infusion and calibration best practices
Short Name: InfusionUptake, Project Number: 15SIP03
State-of-the-art flow metrology incorporated into international medical device standards
For more than 25 years, multiple drug infusions through one injection point (multi-infusion) have been known to cause severe dosing errors. A large percentage of these errors can be avoided if the users of infusion technology have a better understanding of the equipment. The previous EMRP project MeDD highlighted that a factor was lack of guidance on best practices for calibrating such devices.
The standard IEC 60601–2–24:2012 had not fully considered the causes of flow measurement errors, or appreciated the need for robust calibration procedures or specific measurement equipment. The International Standards Organisation’s ISO 7886-2: 1996 Syringes for use with power-driven syringe pumps also did not address causes of flow measurement errors.
This project delivered training to clinicians and suggested amendments to international standards, that included metrology best practices.
Proposals were presented to IEC subcommittee 62D/MT23 in April 2017 and discussions of revisions to IEC 60601-2-24 continued in parallel with a revision to the Association for the Advancement of Medical Instrumentation (AAMI) standard TIR101: Fluid delivery performance testing for infusion pumps. Metrology best practices were also shared with IEC 62D/MT23 in March 2019 to develop IEC 60601-2-24, including proposing a Metrology Annex.
The AAMI standard TIR 101:2021 was published on 15 October 2021 providing guidance for fluid delivery performance test methods, and clinically relevant data of performance in use, including reference to EURAMET’s Calibration Guide No. 19.
The findings of MEDD were presented to ISO Technical Committee 84 working group 11 at the end of this project in 2015 and input made to a first revision of the ISO 7886-2 standard. In 2018 this was upgraded to a committee draft that included metrology best practices.
An e-learning course and workshops addressed risks and best practices for infusion technology was delivered at three hospitals in Portugal and two hospitals in The Netherlands.
A revised standard ISO 7886-2:2020 was published in April 2020, incorporating concepts for measurement uncertainty in its Annex A: Short term flow accuracy, including reference to EURAMET Calibration Guide 19 and GUM – Guide for uncertainty in measurements.
The project supported the development of international standards incorporating robust calibration procedures, capable of supporting accurate drug delivery technologies and reduced risk of related adverse patient incidents.