Catalogo dei Corsi di studio

The course aims to train students of the Master of Science in Biomedical Engineering, in agreement with the International and National Core Competence, who have knowledge and skills essential to the performance of the professional activity aimed at the assessment and management of biomedical technologies in healthcare .
The course objectives are based on the learning of knowledge, skills and methodologies with particular reference to carry out of the testing on the performance of medical devices.
At the end of the learning path the student must be able to acquire professional autonomy, decisional and operational addressed to deal with, identify and manage critical issues during the life cycle of biomedical technologies since they have a high impact on patient and operators safety.

Programme

LECTURES

Health Expenditure
• Public health expenditure and private in OECD Countries. Public health expenditure and private in Italy. Expenditure of biomedical technologies in relation to health expenditure. Park of biomedical equipment installed in the world and in Italy.

Biomedical Technologies Market
• The health and biomedical technologies: definitions and classifications. Life cycle of biomedical technology. Medical devices: definition and types. Analysis of the international market in the field of biomedical technology. Analysis of the national market in the field of biomedical technology.

Regulations in the Health Sector
• Medical Device Directive 42/93 EEC (National Law L.D. 46/97). Medical Device Directive 47/2007 EEC, (National Law L.D. 37/2010). National Laws and Technical Regulations. Classification of medical devices according to the technique "electrical equipment regulations, Part 1: Electrical Safety Standards" CEI 62-5 file 1445, January 1991. Classification of medical locations. National Classification of Medical Devices (CND-D.M. February 20, 2007).

Health Technology Assessment (HTA)
• Health Technology Assessment. Definition, origin and development of Health Technology Assessment (European Directive 24/2001 EEC). Health Technology Assessment in Italy (Ministerial Decree of 12 March 2015). The work flow of Health Technology Assessment for the acquisition of health technologies. Example of evaluation of the acquisition of technology priorities.

Procedures for Purchase
• European Directive 18/2004 EEC. National Law (Ministerial Decree 163/2006). Medical devices Tendering Procedure. Example of information document to be attached to the Request for offer to purchase. Example of a procedure for the Procurement of biomedical equipment in a healthcare. Purchase telematics Procedures (101/2002 DPR). Electronic Tendering Procedure. Electronic Market of the Public Administration (EMPA). Example of Tender. Example of Tender Specifications. Example of telematic procedure of purchase.

Testing
• Public Works Testing: mandatory, purpose and goals. Figure tester. Preliminary test of Compliance. Testing Operations. Visit Report. Test Reports. The Test certificate. General and procedure for the acceptance testing of medical devices. Administrative Testing. Safety testing on electrical devices. Procedure and acceptance control check-list for the archive data to the identifying device. Procedure and check-list for visual inspection and periodic testing. Electrical safety checks of medical electrical equipment in rooms used for medical purposes according to technical standards CEI 62-5 and 62-148. Functional tests. Examples of an electrical safety verification protocol according to the degree of protection against direct contacts, indirect and according to the degree of protection of the applied parts.

Maintenance
• General concepts. Current regulations. Management activities and maintenance of biomedical technologies. Types of maintenance: preventive, corrective, or to failure, periodic and extraordinary. Types of maintenance contracts for technical assistance. Procedure for maintenance plan. Technical inventory procedure. Example technical details of the equipment maintenance activities.

Quality Control in ultrasonography
• Test protocols for verification of ultrasound scanner performance. Functional testing of ultrasound scanner. Guidelines for the evaluation of the image. Ultrasound phantom testing. Biological effects of ultrasound. Mechanical Index. Thermal Index. Guidelines and international recommendations for safe operation. Identification and risk assessment and safety during exposure to ultrasound field.

Clinical Engineering Services
• Clinical Engineering Services: definition, Origin and diffusion. Types of Clinical Engineering Services. The role of the Clinical Engineering Services in the evaluation and management of biomedical technologies.

EXERCISES

Seminars
• Seminars from Professionals representative of the Corporate and Public Entity sector.

Functional test in Laboratory
• Procedure for the carrying out of the functional test related to the quality of the image of a ultrasound equipment by means of ultrasound phantom.
• Data processing and numerical simulations of ultrasound phantom in-silico.
• Comparison between the parameters of the image quality control with the numerical simulations of the ultrasound phantom in-silico.

Adopted texts

TEXTBOOK

• F. P. Branca – Fondamenti di Ingegneria Clinica. Volume 2 Ecotomografia – SPRINGER.
• Lecture notes by the teacher.

Bibliography

• M. Goodsitt, P. L. Carson, S. Witt, D. L. Hykes, J. M. Koffer Jr, “Real time B-mode ultrasound quality control test procedures-Report of AAPM Ultrasound Task Group n°1”, Med. Phys., 25 (8): 1552-1554, 1998. • J.M. Thijssen, G. Weijers, C.L. De Korte, “Objective performance testing and quality assurance of medical ultrasound equipment”, Ultras. in Med. & Biol., 33(3): 460-471, 2007.

Prerequisites

The topics related to the Biomedical Instrumentation II exam are indispensable in order to understand the contents and achieve the learning objectives of the teaching.

Study modes

In the formulation of the training project, the priority is represented by the laboratory test of a functional test that involves the preparation of a final report with an oral exam relating to the interpretation of data and specific technical regulations.

Frequency modes

Laboratory experience for the execution of the functional test relating to the testing of the image of an ultrasound scanner by means of ultrasound phantom.

Exam modes

Oral exam