Highlighted the role of the regulation 2017/745 on medical devices that entered into force on 26th May 2021, MEDD II consortium gives an outlook and a quick landscape review within the relevance of metrological requirements of infusion devices to provide a better shared understanding of this issue.
To read the detailed document, please, follow the link below:
The knowledge, know-how and best practices established within EURAMET Drug delivery projects in the framework of EMPIR are disseminated in standardization through participation in several joint committees working on revision of important standards. The impact of this collaboration is described in detail in an article in EURAMET’s official site. To read the detailed announcement, please, follow the link below:
The theme of the World Metrology Day this year of 2021 is Measurement for Health.
This theme was chosen to create awareness of the important role measurement plays in health, and thus in the wellbeing of every one of us.
World Metrology Day is an annual celebration of the signature of the Metre Convention on 20 May 1875 by representatives of seventeen nations. The Convention set the framework for global collaboration in the science of measurement and in its industrial, commercial and societal applications. The original aim of the Metre Convention – the world-wide uniformity of measurement – remains as important today as it was in 1875. www.worldmetrologyday.org
The project MeDDII has developed a Guide and a Flyer on Calibration of Medical Infusion Pumps as well as a movie on Traceability of infusion pumps: from primary standards to the user to help the understanding of the importance of Metrology in medical devices accuracy .
Infusion is the most used technology in hospitals. Because of its widespread application, often in critical situations and by many users, many infusion errors are made, with some having severe effects. A large percentage of these errors can be avoided if the users of infusion technology have a better understanding of the equipment. This is especially the case in neonatology, where multiple pump infusion is typically combined with low flow rates.
MeDD II EMPIR project
The new Joint Research Project – MeDD II, Metrology for drug delivery funded under the EMPIR program of the European Commission starts in June 2019, will last for three years involving 15 partners, including: 9 National and Designated Metrology Institutes (IPQ- Portugal, CETIAT – France, CMI – Chez Republic, DTI – Denmark, METAS – Switzerland, NEL – United Kingdom, NQIS – Greece, RISE – Sweden and KRISS – Korea), 4 companies (DNV GL – The Netherlands, HSG-IMIT – Germany, INESC MN – Portugal, BHT – The Netherlands) and 2 University Hospitals (THL – Germany, UMCU – The Netherlands).
This project is coordinated by IPQ, the Portuguese Institute of Quality and has the overall objective to improve dosing accuracy and to enable the traceable measurement of volume, flow and pressure in existing drug delivery devices and in-line sensors operating at very low flow rates. This will be achieved through the development of new calibration methods and by expanding the existing metrological infrastructure. This project will also investigate fast changing flow rates, which are step changes between two flow rates within a second, the physical properties of mixtures of liquids and occlusion phenomena in multi-infusion systems in order to prevent inaccurate measurement results and thus to improve patient safety.
1st MEDD II publishable summary
2nd MEDD II publishable summary (M9)
3rd MeDDII-Publishable-Summary (M18)
Between 2012 and 2015, a consortium of 7 metrology institutes, the University Medical Center Utrecht and the Lübeck University of Applied Sciences worked successfully on the development of a metrological infrastructure for accurate drug delivery using infusion. More specifically, drug delivery involving low flow rates (lower than 10 ml/h) and ultra-low flow rates (0.5 ml/h), which is of importance, especially in neonatology. For further details about this project, please have a look at Program JRP.
In addition to the development of the metrological infrastructure in the initial JRP, the researchers investigated parameters that influence the accuracy of the treatment. This included parameters that are related to human behaviour and equipment, e.g. the compliance of syringes.
Support for Impact project
Following this initial project, the consortium would like to share their knowledge and experience gained with the neonatology and IC community in Europe to help improve the accuracy in drug delivery for vulnerable patients.
Therefore, between 2016 and 2019, the consortium will carry out a second, Support for Impact (SIP), project, focusing on sharing knowledge on the risks and best practices related to infusion technology through:
- upgrading and disseminating the e-learning training course on infusion technology;
- articles, trainings and workshops;
- incorporating the best metrology practices relating to calibration of infusion devices standards.
The wider impact of the project is a reduced number of adverse patient incidents related to infusion technology, especially in neonatology where multiple pump infusion is typically combined with low flow rates.