Quantitative Measurements in Medicine
Modern medical diagnosis is based on multi-parametric measurements such as vital signs, blood tests, molecular in-vitro diagnostics and multi-modality imaging data. In the human body all these measurands are related and their measurements need to be accurate, reproducible, comparable and ultimately traceable. These developments are fostered by the trend of precision medicine, which aims at objective medical decisions tailored to individual patients. Although significant effort has been taken over the last decade to support precision medicine with quantitative measurements, these often show a relatively low reproducibility due to technical variations and inter-observer variability. Furthermore uncertainty analysis in biomedical measurements is not straightforward, as there are often many variables, several of them uncontrolled and probably even unknown. Therefore interdisciplinary collaboration between clinical experts, medical physicists, biophysical researchers and industrial developers is necessary.
In the talk a short overview of important developments in quantitative measurements and their biomedical applications are given. Selected examples in for quantitative measurements and analysis in vital signs, in-vitro diagnostics and medical imaging will be shown and discussed.
Tobias Schaeffter studied electrical engineering at TU-Berlin until 1993 and obtained his PhD degree in magnetic resonance (MR) spectroscopic imaging at University Bremen (Prof. Leibfritz) in 1996. From 1996-2006, he worked as a Principal Scientist at the Philips Research Laboratories in Hamburg (Germany), where he was responsible for the development of new MR-acquisition and reconstruction techniques. In April 2006, Professor Schaeffter took up the post as the Philip Harris Professor of Imaging Sciences at King’s College London. A major aim of his research was the investigation of fast and quantitative imaging techniques for cardiovascular applications with a strong focus on translation of biomedical engineering into clinical practice. From 2012 to 2015, he was department head of biomedical engineering and the deputy head of the division in imaging sciences. He taught in the BSc and MSc programmes of Biomedical Engineering and was responsible for the EPSRC doctorial training centre in medical imaging between King’s and Imperial College London. Since 2015 Prof. Schaeffter heads the division of medical physics and metrological information technology at Physikalisch-Technische Bundesanstalt (PTB) in Berlin. He is responsible for the development of new quantitative measurement and reference techniques in medicine. Since January 2019 he is also a Professor in Biomedical Imaging at Technical University Berlin. Prof. Schaeffter has attracted over €10M in grants during the last 5 years and has published over 180 peer-reviewed papers, 10 book chapters, 400 conference abstracts and 30 international patents.
Conformity Assessment of Medical Devices in the Frame of Legal Metrology
Medical devices with measuring function are regularly used in healthcare systems all over the world with the aim of prevention, diagnosis, and treatment of diseases. Considering the importance of these devices in daily activities of medical professionals and impact of their measurements on the health of patients, safety and accuracy of their measurements is becoming the topic of interest. Numerous international guidelines define how healthcare institutions should perform conformity assessment of medical devices, but in some countries, where those guidelines are not adopted, it is necessary to implement regulations and directives of EU new approach for various groups of medical devices. Regulations and Directives of new approach in terms of medical devices and their conformity assessment can be implemented in the area of legal metrology, as it is done in Bosnia and Herzegovina. It is possible to present achievements and activities of Institute of Metrology of Bosnia and Herzegovina (IMBIH), the competent state authority for metrology in Bosnia and Herzegovina, in the area of legal metrology for the particular group of medical devices with measuring function. These achievements and activities refer to the adoption of appropriate legislation for type approval, verification, and creating an adequate legal framework for controlling medical devices after they are sold on the market. In addition, considering complexity and variety of medical devices related to measuring characteristics, and also due to the problem of inadequate or not defined tractability routes, the medical devices will continue to be in focus of metrological practice and science. Establishing the comparative approach to the type approval for these devices in the area of the legal metrology is the final aim.
Zijad Dzemic studied Mechanical Engineering at the University of Sarajevo, where he obtained his Master of Science degree in Technical Sciences. Mr Dzemic has devoted much of his working life in the field of flow of liquids other than water, where he got specialization in Low flow-rate, LSTM at the University of Nurnberg-Erlangen. He has permanent engagement on different subjects at the Faculty of Mechanical Engineering, Electrical Engineering and Civil Engineering at the University of Sarajevo. From 1998 to 2002 he was a Technical Director of Terminal Sarajevo, State Liquid Fuel Storage Co., while in year 2002, he became a Director and later on from 2004 to 2007 he took up the post of the General Director of the same institution. In 2010 Mr Dzemic became the President of Supervisory Board of Elektroprivreda Bosnia and Herzegovina (state Co. that owns hydro/thermo power plants, mines, transportation/distribution system of el. Energy). From 2007 he works at the Institute of Metrology of Bosnia and Herzegovina (IMBiH), as an Executive Director for scientific metrology, and since 2010 is appointed at the post of the General Director. He is responsible for the development of IMBiH and metrology system of Bosnia and Herzegovina over the last decade, where Bosnia and Herzegovina has gained its international recognition in the field of metrology, publishing the first calibration and measurement capabilities in 2012, and which have been nowadays extended covering in total 24 different fields of metrology. Mr Dzemic has organized and managed participation of IMBIH in consortiums of NMIs/DIs (national and designated metrology institutes) in 25 research projects under EMRP and EMPIR. Mr Dzemic is an Author or co-author of the 10 SCI research papers.