Zhivko Bliznakov

A three-dimensional breast software phantom for mammography simulation

This paper presents a methodology for three-dimensional (3D) computer modelling of the breast, using a combination of 3D geometrical primitives and voxel matrices that can be further subjected to simulated x-ray imaging, to produce synthetic mammograms. The breast phantom is a composite model of the breast and includes the breast surface, the duct system and terminal ductal lobular units. Coopers ligaments, the pectoral muscle, the 3D mammographic background and breast abnormalities. A second analytical x-ray matter interaction modelling module is used to generate synthetic images from monoenergetic fan beams. Mammographic images of various synthesized breast models differing in size, shape and composition were produced. A preliminary qualitative assessment performed by three radiologists and a quantitative evaluation study using fractal and grey-level histogram analysis were conducted. A comparative study of extracted features with published data has also been performed. The evaluation results indicated good correlation of characteristics between synthetic and actual radiographs. Applications foreseen are not only in the area of breast imaging experimentation but also in education and training.

Challenges of the biomedical engineering education in Europe

Higher education in Europe has passed through a very dynamic period of changes during the last ten years. Since the signing of the Bologna Declaration in 1999 by the Ministers of Education from the EU states, European higher education system has aimed toward establishing harmonized programs enabling students and teachers to extensively exchange knowledge, ideas and skills. Education in the field of Biomedical Engineering has experienced changes also because of the research and development in the field which was more intensive than in other fields. Besides research in new power sources, it is the most intensive and productive research field. Much of the development in BME education in Europe is influenced by the European research policy expressed through the 7th Framework Programme where health is the major theme. In order to foster and support the changes in the European Higher Education Area (EHEA) according to the needs of research sector and the labor market, the Tempus scheme of projects was established. Tempus scheme aims to support the modernization of higher education and create an area of co-operation in the countries surrounding the EU. Our Tempus project, CRH-BME “Curricula Reformation and Harmonization in the field of Biomedical Engineering” aims to create guidelines for updating existing curricula in the field of BME in Europe in order to meet recent and future developments in the area, address new emerging interdisciplinary domains that appear as the result of the R&D progress and respond to the BME job market demands. In this paper, some policy and economic factors affecting BME education in Europe are discussed and the results of a BME education survey we prepared within the Tempus CHR-BME project are presented. The number of BME programmes in Europe has in the last decade significantly increased and there are more BME specializations as the result of growing complexity of the research and production in the field.

Integrated Software System for Improving Medical Equipment Management

The evolution of biomedical technology has led to an extraordinary use of medical devices in health care delivery. During the last decade, clinical engineering departments (CEDs) turned toward computerization and application of specific software systems for medical equipment management in order to improve their services and monitor outcomes. Recently, much emphasis has been given to patient safety. Through its Medical Device Directives, the European Union has required all member nations to use a vigilance system to prevent the reoccurrence of adverse events that could lead to injuries or death of patients or personnel as a result of equipment malfunction or improper use. The World Health Organization also has made this issue a high priority and has prepared a number of actions and recommendations. In the present workplace, a new integrated, Windows-oriented system is proposed, addressing all tasks of CEDs but also offering a global approach to their management needs, including vigilance. The system architecture is based on a star model, consisting of a central core module and peripheral units. Its development has been based on the integration of 3 software modules, each one addressing specific predefined tasks. The main features of this system include equipment acquisition and replacement management, inventory archiving and monitoring, follow up on scheduled maintenance, corrective maintenance, user training, data analysis, and reports. It also incorporates vigilance monitoring and information exchange for adverse events, together with a specific application for quality-control procedures. The system offers clinical engineers the ability to monitor and evaluate the quality and cost-effectiveness of the service provided by means of quality and cost indicators. Particular emphasis has been placed on the use of harmonized standards with regard to medical device nomenclature and classification. The systems practical applications have been demonstrated through a pilot evaluation trial.

Analysis and Classification of Medical Device Recalls

Medical device recalls by manufacturers contribute to the safe and qualitative function of the devices, in order that incidents which could lead to injuries and deaths are avoided. The present work aims to analyze the data available from the major medical device vigilance systems concerning recalls due to software problems. For this purpose, records from the United States Food and Drug Administration (FDA) for the period 1999–2005 are used. The results from data collection and analysis are presented through the use of ratio indicators and their distribution over the time. Furthermore, classification of the recalls by device categories is performed. The results reveal that one in every three medical devices, making use of software for their operation, has been recalled due to failure in the software itself. In percentage ratios, 11.3% of the total FDA recalls are attributable to software failures. Comparison with previous studies demonstrates increased number of software failure recalls. This indicates the growing importance of software in the domain of medical equipment. The present analysis reveals the tendencies and the areas to focus for the achievement of highest level of safety and quality in biomedical technology.

Review of the Biomedical Engineering Education Programs in Europe within the Framework of TEMPUS IV, CRH-BME Project

Biomedical Engineers should be prepared to adapt to existing or forecasted needs. Today, education in Biomedical Engineering (BME) in Europe is mainly influenced by: a) the European policy on higher education, b) research & development (R&D) programs and c) the market demands. There is a strong pressure on education, training and life long learning programs to continuously adapt their objectives in order to face new requirements and challenges.

Promoting harmonization of BME education in Europe: The CRH-BME Tempus project

Biomedical Engineers should be prepared to adapt to existing or forecasted needs. There is a strong pressure on education, training and life long learning programs to continuously adapt their objectives in order to face new requirements and challenges. The main objective of the TEMPUS IV, CRH-BME project is to update existing curricula in the field of Biomedical Engineering (BME) in order to meet recent and future developments in the area, address new emerging inter-disciplinary domains that appear as a result of the R&D progress and respond to the BME job market demands. The first step is to extensively review the curricula in the BME education field. In this paper, a proposal for a generic curriculum in the BME education is presented, in order to meet recent and future developments and respond to the demands of the BME job market. Adoption of the core program structure will facilitate harmonization of studies as well as student and staff exchange across Europe, thus promoting the European Higher Education Area.

Overview of Biomedical Engineering Education Programs in Europe: The Results of the CRH-BME Project Survey

Biomedical Engineering (BME) is considered today as one of the most promising job of the future. Education in BME in Europe during the last decade has been mainly influenced by: The European policy on higher education, research & development (R&D) programs in the field and the market demands. Due to the rapid technological progress in the field there is a strong pressure on education, training and life long learning programs to continuously adapt their objectives in order to face new requirements and challenges.

Modeling of small carbon fiber-reinforced polymers for X-ray imaging simulation

A methodology for generation of realistic three-dimensional software models of carbon fiber-reinforced polymer (CFRP) structures, dedicated for use in simulation studies of advanced X-ray imaging techniques for non-destructive testing (NDT), has been developed, implemented, and evaluated. Two CFRP models are presented in this paper, one built as a set of stacked layers that contain continuous carbon bundles and a second as a braided textile from woven carbon bundles. The following CFRP defects were modeled: porosity, missing carbon bundles, and non-carbon inclusions. X-ray projection images were generated using an in-house developed X-ray imaging simulator. The obtained preliminary visual and quantitative validation results showed an overall good correlation of characteristics between synthetic and experimental data radiographs and justify the use of this model for research in CFRP X-ray imaging. The application of the CFRP model is demonstrated in a feasibility study that aims to computationally evaluate the appropriateness of two advanced X-ray imaging techniques: cone-beam CT (CBCT) and tomosynthesis (limited arc tomography), as inspection techniques for NDT of CFRP parts. The simulation showed that in all cases the CBCT approach outperformed both conventional radiography and tomosynthesis in terms of defect characterization and visualization.

Medical Devices Recalls Analysis Focusing on Software Failures during the Last Decade

The purpose of the present work is to present up-to-date information concerning MD recalls due to software failures. For this purpose, data from the United States Food and Drug Administration (FDA) Enforcement Reports for the period 1999-2010 have been used. The outcomes from data collection and analysis are presented through the use of ratio indicators and their distribution over the time. Furthermore, classifications of the MD recalls according to reasons of failure and the level of health hazard have been performed.

Study of suitability of new materials for use with physical breast phantoms

Emerging X-ray breast imaging applications require the use of realistic physical three-dimensional phantoms are breast CT, phase-contrast mammography and the existing breast Tomosynthesis, dedicated to screen as early as possible and diagnose cancer in breast. However, manufacturing of such phantoms meets difficulties related to the current technology, suitable materials, manufacturing precision, format of the software models. This paper reports the preliminary results from simulation studies aiming to investigate mixtures prepared from epoxy resin and iodine powder in specific ratios as tissue substitutes for X-ray breast imaging. For each material, mass and linear attenuation coefficients were calculated for the X-ray energy range from 10 to 32 keV. Mixtures of epoxy resin and up to 1.8% iodine powder turn to be a suitable option for tissue substitutes. Selected materials were used in simulations of breast lesions with blurry edges.