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Ferreira M.D.C.,Instituto Portugues da Qualidade | Ferreira M.D.C.,Portuguese Institute for Quality
Joint IMEKO TC11-TC19-TC20 Int. Symp. Metrological Infrastructure, Environmental and Energy Measurement and Int. Symp. of Energy Agencies of Mediterranean Countries, IMEKO-MI 2011 | Year: 2011

Medical measurements are present in the everyday life of people and are fundamental processes in prevention, diagnosis and treatment of disease. Therefore, a growing interest lies in the role of metrological decisions and conformity assessment, namely where measurements are in support of health. This paper focuses on the use of medical devices looking to enhance its metrological traceability, highlighting the specific role of metrology in the field of health care and the impact of legal control in the framework of the medical devices regulation with a measuring function. It is proposed a new regulatory approach for medical devices in use, facing the convergence between European policy enforcement and Metrological regulations.


Batista E.,Portuguese Institute for Quality | Almeida N.,Portuguese Institute for Quality | Furtado A.,Portuguese Institute for Quality | Filipe E.,Portuguese Institute for Quality | And 6 more authors.
Biomedizinische Technik | Year: 2015

For critical drug delivery, it is important to have a constant and well-known infusion rate delivered by the complete infusion set-up (pump, tubing, and accessories). Therefore, various drug delivery devices and accessories were tested in this article in terms of their infusion accuracy, start-up delay, response time, and dependency on the viscosity. These measurements were performed as part of the European funded research project MeDD. The obtained results show that the infusion accuracy of the devices is flow rate and accessory depended, especially for low flow rates. Viscosity does not have a significant impact on the flow rate accuracy. © 2015 by De Gruyter.


Bissig H.,Federal Institute of Metrology | Petter H.T.,VSL BV Dutch Metrology Institute | Lucas P.,VSL BV Dutch Metrology Institute | Batista E.,Portuguese Institute for Quality | And 10 more authors.
Biomedizinische Technik | Year: 2015

Microflow and nanoflow rate calibrations are important in several applications such as liquid chromatography, (scaled-down) process technology, and special health-care applications. However, traceability in the microflow and nanoflow range does not go below 16 μl/min in Europe. Furthermore, the European metrology organization EURAMET did not yet validate this traceability by means of an intercomparison between different National Metrology Institutes (NMIs). The NMIs METAS, Centre Technique des Industries Aérauliques et Thermiques, IPQ, Danish Technological Institute, and VSL have therefore developed and validated primary standards to cover the flow rate range from 0.1 μl/min to at least 1 ml/min. In this article, we describe the different designs and methods of the primary standards of the gravimetric principle and the results obtained at the intercomparison for the upper flow rate range for the various NMIs and Bronkhorst High-Tech, the manufacturer of the transfer standards used. © 2015 by De Gruyter.


Do Ceu Ferreira M.,Portuguese Institute for Quality | Do Ceu Ferreira M.,University Sidi Mohammed Ben Abdellah | Matos A.,University Sidi Mohammed Ben Abdellah | Leal R.P.,University Sidi Mohammed Ben Abdellah
Accreditation and Quality Assurance | Year: 2015

To evaluate the role of metrology in healthcare facilities, a study was performed among Portuguese hospitals to identify and analyze issues concerning the concept of metrological traceability. The discussion is structured around a dataset obtained from a survey questionnaire covering 44 public and private Portuguese hospitals. The principal results of our analysis include identifying some key indicators that apply to certified/accredited hospitals. Test reports and calibration certificates were the main metrological traceability documents required by the hospitals. The acquisition of medical measuring instruments with conformity reports depended on the type of hospital. Maintenance was considered the most relevant issue for private hospitals, whereas for the public hospitals, this issue is less important than trust in the supplier. For public hospitals, purchase price was the most important requirement. For hospitals that acquire calibrated measuring instruments, only 50 % perform in-house calibration. We conclude that trust in supplier is associated with a lower overall budget for maintenance operations. The protocol established by hospitals to acquire measurement instruments does not reflect metrological concerns, and the relationship between maintenance and metrological operation is not well established. Thus, we conclude that metrological traceability is largely absent in the daily considerations of healthcare professionals and facilities. © 2015 Springer-Verlag Berlin Heidelberg


Ferreira M.,Portuguese Institute for Quality | Matos A.,UNIDEMI
Journal of Physics: Conference Series | Year: 2015

The purpose of this paper is to identify and analyze some relevant issues which arise when the concept of metrological traceability is applied to health care facilities. Discussion is structured around the results that were obtained through a characterization and comparative description of the practices applied in 45 different Portuguese health entities. Following a qualitative exploratory approach, the information collected was the support for the initial research hypotheses and the development of the questionnaire survey. It was also applied a quantitative methodology that included a descriptive and inferential statistical analysis of the experimental data set. © Published under licence by IOP Publishing Ltd.


Do Ceu Ferreira M.,Portuguese Institute for Quality
International Journal of Metrology and Quality Engineering | Year: 2011

Medical measurements are present in the everyday life of people and are fundamental processes in prevention, diagnosis and treatment of disease. Therefore, a growing interest lies in the role of metrological decisions and conformity assessment, namely where measurements are in support of health. This paper focuses on the use of medical devices looking to enhance its metrological traceability, highlighting the specific role of metrology in the field of health care and the impact of legal control in the framework of the medical devices regulation with a measuring function. It is proposed a new regulatory approach for medical devices in use, facing the convergence between European policy enforcement and Metrological regulations. © EDP Sciences 2012.


do Ceu Ferreira M.,Portuguese Institute for Quality | Matos A.,UNIDEMI | Leal R.P.,UNIDEMI
Accreditation and Quality Assurance | Year: 2015

To evaluate the role of metrology in healthcare facilities, a study was performed among Portuguese hospitals to identify and analyze issues concerning the concept of metrological traceability. The discussion is structured around a dataset obtained from a survey questionnaire covering 44 public and private Portuguese hospitals. The principal results of our analysis include identifying some key indicators that apply to certified/accredited hospitals. Test reports and calibration certificates were the main metrological traceability documents required by the hospitals. The acquisition of medical measuring instruments with conformity reports depended on the type of hospital. Maintenance was considered the most relevant issue for private hospitals, whereas for the public hospitals, this issue is less important than trust in the supplier. For public hospitals, purchase price was the most important requirement. For hospitals that acquire calibrated measuring instruments, only 50 % perform in-house calibration. We conclude that trust in supplier is associated with a lower overall budget for maintenance operations. The protocol established by hospitals to acquire measurement instruments does not reflect metrological concerns, and the relationship between maintenance and metrological operation is not well established. Thus, we conclude that metrological traceability is largely absent in the daily considerations of healthcare professionals and facilities. © 2015, Springer-Verlag Berlin Heidelberg.

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