Assessment of drug delivery devices

Batista, Elsa; Almeida, Nelson; Furtado, Andreia; Filipe, Eduarda; Sousa, Luís de; Martins, Rui F.; Lucas, Peter; Petter, Harm Tido; Snijder, Roland A.; Timmerman, Annemoon

doi:10.1515/bmt-2014-0138

Cited by 18 publications

(15 citation statements)

References 4 publications

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“…in this “color-blind” calculation, only the total flow rate inside the catheter is calculated. The mechanical compliance of the catheter is very small with respect to the mechanical compliance of the syringes [18], and therefore the mechanical compliance of the catheter is neglected in our model. As a result, the flow rate entering the tube at time t and the flow rate leaving the tube (entering the blood stream) at the same time t are both equal to , disregarding the different constitutions that the fluids entering, and leaving, respectively, may have in terms of the partial fluids R, G, and B.…”

Section: Method: Analytical Model and In-vitro Set-upmentioning

confidence: 99%

Analytical method for calculation of deviations from intended dosages during multi-infusion

et al. 2017

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BackgroundIn this paper, a new method is presented that combines mechanical compliance effects with Poiseuille flow and push-out effects (“dead volume”) in one single mathematical framework for calculating dosing errors in multi-infusion set-ups. In contrast to existing numerical methods, our method produces explicit expressions that illustrate the mathematical dependencies of the dosing errors on hardware parameters and pump flow rate settings.MethodsOur new approach uses the Z-transform to model the contents of the catheter, and after implementation in Mathematica (Wolfram), explicit expressions are produced automatically. Consistency of the resulting analytical expressions has been examined for limiting cases, and three types of in-vitro measurements have been performed to obtain a first experimental test of the validity of the theoretical results.ResultsThe relative contribution of various factors affecting the dosing errors, such as the Poiseuille flow profile, resistance and internal volume of the catheter, mechanical compliance of the syringes and the various pump flow rate settings, can now be discerned clearly in the structure of the expressions generated by our method. The in-vitro experiments showed a standard deviation between theory and experiment of 14% for the delay time in the catheter, and of 13% for the time duration of the dosing error bolus.ConclusionsOur method provides insight and predictability in a large range of possible situations involving many variables and dependencies, which is potentially very useful for e.g. the development of a fast, bed-side tool (“calculator”) that provides the clinician with a precise prediction of dosing errors and delay times interactively for many scenario’s. The interactive nature of such a device has now been made feasible by the fact that, using our method, explicit expressions are available for these situations, as opposed to conventional time-consuming numerical simulations.

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Section: Method: Analytical Model and In-vitro Set-upmentioning

confidence: 99%

Analytical method for calculation of deviations from intended dosages during multi-infusion

et al. 2017

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“…The infrastructure, consisting of traceable calibration services for drug delivery systems for flow rates down to 100 nL/min was developed in five European National Metrology Institutes (NMIs) [6,7]. Syringe pumps and peristaltic pumps with accessories were tested [8]. The effects of variations in several physical parameters in infusion systems were incorporated in a predictive model [9].…”

Section: State Of the Art And Progress Beyond Itmentioning

confidence: 99%

New EMPIR project – Metrology for Drug Delivery, the role of IPQ

Batista

Ferreira

Furtado

et al. 2019

2019 IEEE International Symposium on Medical Measurements and Applications (MeMeA)

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This article presents the state of the art and expected progress beyond it, scientific objectives, and the expected impact on metrology, standards, and society of the new Joint Research Project-MeDD II, Metrology for drug delivery, selected for funding through the EURAMET (European Association of National Metrology Institutes) EMPIR (European Metrology Programme for Innovation and Research) programme of the European Commission and the participating countries. It also specifies the role of IPQ as coordinator and Work Package leader of Impact. This project will start in June 2019, for three years. It involves 15 participants from National and Designated Metrology Institutes, Companies, Hospitals and Academia and has the main objective of enabling traceable measurements of volume, flow and pressure of existing drug delivery devices (and other medical devices, like infusion pumps analysers) and inline sensors that work at a flow rate lower than 100 nL/min, in order to prevent inaccurate measurement results. This project will also investigate fast changing flow rate, liquid mixing behaviour and occlusion phenomena in multi-infusion systems with the purpose of improving dosing accuracy in each infusion line. IPQ will develop an optical method in order to decrease the validated CMC range.

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“…Les figures 10 à 13 présentent les deux caractéristiques pour lesquelles les résultats les plus intéressants ont été obtenus, soit le temps de démarrage et la compliance des systèmes évalués. L'ensemble des mesures réalisées dans ce lot de tâches (n • 3) est détaillé dans l'article de Bastista [4].…”

Section: Caractérisation De L'influence De La Température Sur Les Perunclassified

Validation d’un banc d’étalonnage primaire en microdébitmétrie liquide et application aux dispositifs médicaux de perfusion

Ogheard¹

2016

R. franç. métrol.

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Antérieurement à 2012, la traçabilité des mesures de micro-et nanodébits de liquides (de l'ordre de 1 mL•h −1 et en deçà) n'était pas assurée en raison de l'absence de références métrologiques. Pour des applications liées au secteur de la santé, telle que l'administration de médicaments par perfusion, l'incertitude sur le débit réel d'injection aux patients peut avoir des conséquences dramatiques, voire létales. La qualité du dosage volumétrique est de fait un paramètre critique très important à maîtriser. La connaissance précise du volume administré et la stabilité du débit d'injection sont cruciales, particulièrement pour les médicaments qui requièrent une très faible concentration sanguine pour des raisons de toxicité, tels que les médicaments vasoactifs ou anesthésiants. Pour répondre à ce besoin, les laboratoires nationaux de métrologie LNE-CETIAT, DTI, IPQ, METAS et VSL ont développé, dans le cadre du projet européen de recherche "EMRP/HLT07 MeDD-Metrology for Drug Delivery", des installations d'étalonnage couvrant une gamme de débits de liquide allant de 600 nL•h −1 à 600 mL•h −1. Cet article présente le travail effectué au LNE-CETIAT dans le cadre de ce projet, consistant à qualifier un banc de référence pour des débits de liquide compris entre 1 mL•h −1 et 10 L•h −1 et à étudier l'influence de la température sur les performances métrologiques des microdébitmètres et dispositifs médicaux de perfusion.

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Assessment of drug delivery devices

Cited by 18 publications

References 4 publications

Analytical method for calculation of deviations from intended dosages during multi-infusion

Analytical method for calculation of deviations from intended dosages during multi-infusion

New EMPIR project – Metrology for Drug Delivery, the role of IPQ

Validation d’un banc d’étalonnage primaire en microdébitmétrie liquide et application aux dispositifs médicaux de perfusion

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