Lecturer: Angelo Buizza  

Course name: Clinical Engineering
Course code: 062174
Degree course: Ingegneria Biomedica
Disciplinary field of science: ING-INF/06
L'insegnamento è caratterizzante per: Ingegneria Biomedica
University credits: CFU 5
Course website: http://aim.labmedinfo.org/

Specific course objectives

This course aims at introducing the principles and tools for healthcare technology (medical devices and systems, information and communication technologies) management in a hospital environment. The student will acquire basic methodological skills for an easy access to the structures and services responsible for medical technology management, such as clinical engineering departments and services, either internal to the hospital or providing in-service support.

Course programme

Regulations, Standards and Norms concerning medical devices. EU context; EU directives; the 93/42/EEC directive on medical devices; harmonised standards and norms.

Electrical safety in the clinical environment.
Electrocution, physiological effects of electric current, macro- e micro-shock. Safety of electromedicals: IEC EN 60601.1 standard. Electrical safety of power distribution system in a hospital: Italian regulations and standards. Case studies.

Management of medical technology.
Acquisition of new equipment and relevant procedures; incoming inspection and acceptance; maintenance of medical technology: different kinds of maintenance, maintenance programme, organization, scheduling, realization; electrical safety program; technology replacement planning, criteria and tools; software tools supporting technology management organisation.

Clinical Engineering Service.
History, functions, structure, organisation, responsibilities, implementation, evalutation. Health Technology Assessment: overview, basic principles, different levels.

Course entry requirements

Fundamentals of electrical and electronic circuits.

Course structure and teaching

Lectures (hours/year in lecture theatre): 30
Practical class (hours/year in lecture theatre): 15
Practicals / Workshops (hours/year in lecture theatre): 0

Suggested reading materials

Buizza A., Genduso G., Pagliaro A.. La gestione della strumentazione biomedica nella nuova organizzazione sanitaria. Pavia: CBIM, 2000.

Lamberti C., Rainer W.. Le apparecchiature biomediche e la loro gestione. Bologna: Pātron, 1998.

Lecture notes provided by the teacher and made available through the course website (http://aim.labmedinfo.org).. .

Testing and exams

Written test concerning an electrical safety case study, followed by oral examination. Admission to the oral exam requires the candidate to earn a score of at least 16/30 in the written test.