Lecturer: Angelo Buizza  

Course name: Clinical Engineering
Course code: 502503
Degree course: Bioingegneria
Disciplinary field of science: ING-INF/06
University credits: ECTS 6
Course website: http://lotarionline.unipv.it/moodle/

Specific course objectives

The course will introduce the principles and tools for correct management of healthcare technology (medical devices and systems, information and communication technologies) in a hospital environment. The student will gain consciousness of the technological, organisational and economical implications of the use of technology in healthcare, and acquire basic methodological and operational skills for 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; the New Approach; EU directives; the 93/42/EEC and 2007/47/EEC directives on medical devices; harmonised EU 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, evaluation of Clinical Engineering Service. Health Technology Assessment: overview, basic principles, different levels.

Course entry requirements

Fundamentals of electric and electronic circuits.

Course structure and teaching

Lectures (hours/year in lecture theatre): 39
Practical class (hours/year in lecture theatre): 12
Practicals / Workshops (hours/year in lecture theatre): 0

Suggested reading materials

Lecture notes provided by the teacher and made available through the course website http://lotarionline.unipv.it/moodle/.

Testing and exams

Written exam.