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Medical devices and health technology

Objective

Specific Objectives:
1. To assess and validate measurement and testing methods in the fields of biophotonics and biomechanics, in particular for medical imaging, diagnosis and monitoring of disease, advanced biosensor systems, optical methods for tissue engineering science, and biomechanical characterisation of calcified tissues and bone interfaces (also related to tissue engineering);
2. To improve the efficiency of the production of selected radioisotopes, requested by medical research, by testing new production routes and developing more efficient targets;
3. To provide irradiation facilities, nuclear expertise and training in support of applications in the field of health, including radiotracer studies concerning toxicology (ECVAM), and facilities and support for developing routine production of radio-isotopes and for the Marie Curie Training Site BIORAD;
4. To define, together with relevant internal/external groups, actions aimed at improving health information systems, at contributing to technology assessment and monitoring, and at supporting in collaboration with IPTS prospective techno-socio-economic studies on future technological developments in the health care sector.

Anticipated milestones and schedule TASK 1 May 31: Implementation of a quality scheme for cyclotron operation June 30: Cyclotron revision finished and ready for production of 18F for industrial partner Sept. 30: Safety analysis for production of 211.

At with liquid metal targets, design of target system (collaboration INFN Milano, M. Bonardi) Dec. 20: Foresight: Report on non-commercial radioisotopes with increasing demand in nuclear medicine TASK 2 May. 31: realisation and testing of Bragg sensor for in vivo distributed temperature measurement July 31: full characterisation and clinical trials of fluorescence endoscope Oct. 31:Demonstration of laboratory setups for OCT based tissue imaging Nov. 15:Assessment of the nanoindentation technique for characterising bone tissue Dec. 20: Design and prototyping of selected optical wave guide biosensors (collaboration ECVAM) TASK 3 June 31: Definition of needs of DG SANCO in support of Health Policy, HTA and Technology Foresight within the Public Health Programme.
Planned Deliverables technical reports on cyclotron radio-isotope production, imaging fluorescence spectroscopy for medical diagnostics, and in-vivo Bragg grating measurement of temperature profiles. peer-reviewed publications on (1) application of fluorescence imaging endoscopy, (2) spectral filtering using acousto-optic tunable elements, (3) radioisotope production methods 1 patents related to optical diagnostic methods training: four students (graduate/post-graduate) support to policy development (where requested) assessments of specific policy-related topics (as requested).
Summary of the Action:
In support of the current and developing legal framework, this JRC Action tackles issues of medium to long term relevance and is geared to respond to key challenges for European health care systems driving policy development:
1. ageing of the European population and associated increase of incidence of cancer, musculoskeletal and cardiovascular disease;
2. rapid development of health technology;
3. financial sustainability of health care systems;
4. increased user and patient expectations and demands on health services;
5. inequality in access to health services.

In particular, the action supports S&T development in technologies for preventative medicine and diagnostic systems, medical devices, and tissue engineering, that require extensions to the current regulatory framework. In view of socio-economic issues, the action will, where appropriate, contribute to the assessment of the effectiveness, cost-effectiveness and appropriate use of health technologies, and to the development of health information systems. The main aim is to develop methods and materials to ensure safety, quality and reliability of medical devices and biomedical systems. Networking with all stakeholders aims to define and disseminate best practices and to improve the availability of medical applications of nuclear technologies.

The action has been broken down into the following tasks:
1. Biomedical Radioisotope Production;
2. Biophotonics and biomechanics;
3. Technology assessment, foresight studies, health information systems Rationale This JRC action addresses key aspects in relation to the Public Health Programme of Action and the Medical Device Directive (and related directives). The proposed programme of action in the field of Public Health for the years 2001-2006 sets out a new health strategy that covers Community policies and activities related to health in line with Article 152 of the Treaty.

It defines a group of specific objectives and actions focusing on three priorities:
1) Improving Health Information and Knowledge;
2) Responding rapidly to Health Threats;
3) Addressing Health Determinants. For the marketing and putting into service of medical devices, a Community wide legal framework (Medical Devices Directive 93/42/EEC and related directives) has been set up in order to protect users and patients and at the same time allowing them to benefit from technological progress and innovation. Research and innovation in health technology is more dynamic than ever before. In order to be well placed to address emerging policy issues the JRC needs to be active in this politically important field and to be flexible enough to respond to a wide range of issues.

Funding Scheme

JRC - Joint Research Centre research

Coordinator

Institute for Health and Consumer Protection
Address
Via E. Fermi 1
21020 Ispra
Italy