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  • 1.
    Bissig, Hugo
    et al.
    METAS Federal Institute of Metrology, Switzerland.
    Büker, Oliver
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Stolt, Krister
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Batista, Elsa
    IPQ Metrology Department, Portugal.
    Afonso, Joana
    NOVA School of Science and Technology, Portugal.
    Zagnoni, Michele
    University of Strathclyde, UK.
    Vroman, Rozan
    University of Strathclyde, UK.
    Kjeldsen, Henrik
    DTI Danish Technological Institute, Denmark.
    Niemann, Anders
    DTI Danish Technological Institute, Denmark.
    Schroeter, Joerk
    Technische Hochschule Lübeck, germany.
    Calibration of insulin pumps based on discrete doses at given cycle times2023Ingår i: Biomedizinische Technik (Berlin. Zeitschrift), ISSN 1862-278X, E-ISSN 0013-5585, Vol. 68, nr 1, s. 67-77Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    One application in the medical treatment at very small flow rates is the usage of an Insulin pump that delivers doses of insulin at constant cycle times for a specific basal rate as quasi-continuous insulin delivery, which is an important cornerstone in diabetes management. The calibration of these basal rates are performed by either gravimetric or optical methods, which have been developed within the European Metrology Program for Innovation and Research (EMPIR) Joint Research Project (JRP) 18HLT08 Metrology for drug delivery II (MeDDII). These measurement techniques are described in this paper, and an improved approach of the analytical procedure given in the standard IEC 60601-2-24:2012 for determining the discrete doses and the corresponding basal rates is discussed in detail. These improvements allow detailed follow up of dose cycle time and delivered doses as a function of time to identify some artefacts of the measurement method or malfunctioning of the insulin pump. Moreover, the calibration results of different basal rates and bolus deliveries for the gravimetric and the optical methods are also presented. Some analysis issues that should be addressed to prevent misinterpreting of the calibration results are discussed. One of the main issues is the average over a period of time which is an integer multiple of the cycle time to determine the basal rate with the analytical methods described in this paper. 

  • 2.
    Bissig, Hugo
    et al.
    NQIS/EIM Sindos, Greece.
    Büker, Oliver
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Stolt, Krister
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Graham, Emmelyn
    TUV SUD National Engineering Laboratory, UK.
    Wales, Leslie
    TUV SUD National Engineering Laboratory, UK.
    Furtado, Andreia
    IPQ Metrology Department, Portugal.
    Moura, Sara
    IPQ Metrology Department, Portugal.
    Metaxiotou, Zoe
    NQIS/EIM Sindos, Greece.
    Lee, Seok Hwan
    KRISS, South Korea.
    Kartmann, Sabrina
    Hahn-Schickard-Gesellschaft fur Angewandte Forschung EV, Germany.
    Groenesteijn, Jarno
    Bronkhorst High-Tech BV, Netherlands.
    Lotters, Joost C
    Bronkhorst High-Tech BV, Netherlands.
    In-line measurements of the physical and thermodynamic properties of single and multicomponent liquids2023Ingår i: Biomedizinische Technik (Berlin. Zeitschrift), ISSN 1862-278X, E-ISSN 0013-5585, Vol. 68, nr 1, s. 39-50Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Microfluidic devices are becoming increasingly important in various fields of pharmacy, flow chemistry and healthcare. In the embedded microchannel, the flow rates, the dynamic viscosity of the transported liquids and the fluid dynamic properties play an important role. Various functional auxiliary components of microfluidic devices such as flow restrictors, valves and flow meters need to be characterised with liquids used in several microfluidic applications. However, calibration with water does not always reflect the behaviour of the liquids used in the different applications. Therefore, several National Metrology Institutes (NMI) have developed micro-pipe viscometers for traceable inline measurement of the dynamic viscosity of liquids used in flow applications as part of the EMPIR 18HLT08 MeDDII project. These micro-pipe viscometers allow the calibration of any flow device at different flow rates and the calibration of the dynamic viscosity of the liquid or liquid mixture used under actual flow conditions. The validation of the micro-pipe viscometers has been performed either with traceable reference oils or with different liquids typically administered in hospitals, such as saline and/or glucose solutions or even glycerol-water mixtures for higher dynamic viscosities. Furthermore, measurement results of a commercially available device and a technology demonstrator for the inline measurement of dynamic viscosity and density are presented in this paper. © 2022 the author(s)

  • 3.
    Håkansson, Joakim
    et al.
    RISE Research Institutes of Sweden, Material och produktion, Metodik för produktframtagning. University of Gothenburg, Sweden.
    Jenndahl, Lachmi
    Verigraft Ab, Sweden.
    Simonsson, Stina
    University of Gothenburg, Sweden.
    Johansson, Martin E
    University of Gothenburg, Sweden; Sahlgrenska University Hospital, Sweden.
    Larsson, Karin
    University of Gothenburg, Sweden.
    Strehl, Raimund
    Verigraft AB, Sweden.
    Olsen Ekerhult, Teresa
    University of Gothenburg, Sweden; Sahlgrenska University Hospital, Sweden.
    De- and recellularized urethral reconstruction with autologous buccal mucosal cells implanted in an ovine animal model2023Ingår i: Biomedizinische Technik (Berlin. Zeitschrift), ISSN 1862-278X, E-ISSN 0013-5585Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Patients with urethral stricture due to any type of trauma, hypospadias or gender dysphoria suffer immensely from impaired capacity to urinate and are in need of a new functional urethra. Tissue engineering with decellularization of a donated organ recellularized with cells from the recipient patient has emerged as a promising alternative of advanced therapy medicinal products. The aim of this pilot study was to develop an ovine model of urethral transplantation and to produce an individualized urethra graft to show proof of function in vivo. Donated urethras from ram abattoir waste were decellularized and further recellularized with autologous buccal mucosa epithelial cells excised from the recipient ram and expanded in vitro. The individualized urethral grafts were implanted by reconstructive surgery in rams replacing 2.5 ± 0.5 cm of the native penile urethra. After surgery optimization, three ram had the tissue engineered urethra implanted for one month and two out of three showed a partially regenerated epithelium. Further adjustments of the model are needed to achieve a satisfactory proof-of-concept; however, we interpret these findings as a proof of principle and a possible path to develop a functional tissue engineered urethral graft with de- and recellularization and regeneration in vivo after transplantation. 

  • 4.
    Mills, Chris
    et al.
    TUV SUD National Engineering Laboratory, UK.
    Batista, Elsa
    Instituto Portugues da Qualidade, Portugal.
    Bissig, Hugo
    METAS, Switzerland.
    Ogheard, Florestan
    Centre Technique des Industries Aerauliques et Thermiques, France.
    Boudaoud, Abir
    Centre Technique des Industries Aerauliques et Thermiques, France.
    Büker, Oliver
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Stolt, Krister
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Morgan, John
    TUV SUD National Engineering Laboratory, UK.
    Kartmann, Sabrina
    Hahn-Schickard, Germany.
    Thiemann, Kerstin
    Hahn-Schickard, Germany.
    Miotto, G.
    Hahn-Schickard, Germany.
    Niemann, Anders
    DTI, Denmark.
    Klein, Stephan
    Technische Hochschule Luebeck, Germany.
    Ratering, Geist
    Bronkhorst High-Tech BV, Netherlands.
    Lötters, Joost
    Bronkhorst High-Tech BV, Netherlands.
    Calibration methods for flow rates down to 5 nL/min and validation methodology2023Ingår i: Biomedizinische Technik (Berlin. Zeitschrift), ISSN 1862-278X, E-ISSN 0013-5585, Vol. 68, nr 1, s. 13-27Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Improving the accuracy and enabling traceable measurements of volume, flow, and pressure in existing drug delivery devices and in-line sensors operating at very low flow rates is essential in several fields of activities and specially in medical applications. This can only be achieved through the development of new calibration methods and by expanding the existing metrological infrastructure to perform micro-flow and nano-flow measurements. In this paper, we will investigate new traceable techniques for measuring flow rate, from 5 nL/min to 1,500 nL/min and present the results of an inter-comparison between nine laboratories for the calibration of two different flow meters and a syringe pump. 

  • 5.
    Niemann, Anders
    et al.
    DTI Danish Technological Institute, Denmark.
    Batista, Elsa
    Portuguese Institute for Quality, Portugal.
    Geršl, Jan
    CMI, Czech Republic.
    Bissig, Hugo
    METAS, Switzerland.
    Büker, Oliver
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Lee, Seok
    KRISS, South Korea.
    Graham, Emmelyn
    TUV SUD NEL, UK.
    Stolt, Krister
    RISE Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Afonso, Joana
    NOVA School of Science and Technology, Portugal.
    Benková, Miroslava
    CMI, Czech Republic.
    Knotek, Stanislav
    CMI, Czech Republic.
    Assessment of drug delivery devices working at microflow rates2023Ingår i: Biomedizinische Technik (Berlin. Zeitschrift), ISSN 1862-278X, E-ISSN 0013-5585, Vol. 68, nr 1, s. 51-65Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Almost every medical department in hospitals around the world uses infusion devices to administer fluids, nutrition, and medications to patients to treat many different diseases and ailments. There have been several reports on adverse incidents caused by medication errors associated with infusion equipment. Such errors can result from malfunction or improper use, or even inaccuracy of the equipment, and can cause harm to patients' health. Depending on the intended use of the equipment, e.g. if it is used for anaesthesia of adults or for medical treatment of premature infants, the accuracy of the equipment may be more or less important. A well-defined metrological infrastructure can help to ensure that infusion devices function properly and are as accurate as needed for their use. However, establishing a metrological infrastructure requires adequate knowledge of the performance of infusion devices in use. This paper presents the results of various tests conducted with two types of devices. © 2022 the author(s)

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