Università Roma Tre

Clinical engineering: glossary of terms; definition and classification of medical devices; national and international outlook of clinical engineering; clinical engineering competences.
Specifications of a selection of medical devices: reading, comprehension and writing of the technical specifications.
Management and maintenance of medical devices: inventory, national classification of medical devices (CND); global medical device nomenclature (GMDN). Entity-relationship diagram models.
Probability theory fundamentals for the maintenance of medical devices: reliability and availability; failure rate, and other relevant indicators: costs and times; maintenance strategies, roles and duties.
Life Cycle Cost Analysis (LCCA) in the healthcare sector; health technology assessment: indicators of clinical efficacy (QALY, DALY); economic burden.
Regulations in the healthcare sector (national level), and comparison at the international level; WHO directives and recommendations. Bismarck-Beveridge and mixed models.
Efficiency of a healthcare structure: indicators for outpatients and inpatients; hospital environment: risk evaluation and minimization; relevant indicators.

Slides, exercises and other material freely available for students at http://biolab.uniroma3.it or on the University moodle platform.
Further readings:
- C. LAMBERTI, W. RAINER. LE APPARECCHIATURE BIOMEDICHE E LA LORO GESTIONE, PATRON EDITORE, 1998.
- F. PINCIROLI, S. BONACINA. APPLICAZIONI DI SANITÀ DIGITALE, POLIPRESS, 2009.