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 awareness 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 Prerequisites
Fundamentals of electric and electronic circuits.
Teaching Methods
Lectures concerning the different aspects and phases of health technology management in a hospital setting. Seminars by professional on specific relevant topics.
Assessment Methods
Written exam.
Texts
Lecture notes by the teacher (in Italian), made available through the website https://elearning.unipv.it/)
Contents
Regulations, Standards and Norms concerning Medical Devices - EU context; the New Approach; the new regulation UE 2017/745 on medical devices (MDR); harmonised EU standards and norms. Electrical safety in the clinical environment - Electrocution, physiological effects of electric current, macro- and 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, IEC EN 62353 norm; technology replacement planning, criteria and tools; software tools supporting technology management organisation. Clinical Engineering Services - History, functions, structure, organisation, responsibilities, implementation, evaluation of Clinical Engineering Service. Health Technology Assessment: overview, basic principles, different levels.
