Integrated software system for improving medical equipment management

The evolution of biomedical technology has led to an extraordinary use of medical devices in health care delivery. During the last decade, clinical engineering departments (CEDs) turned toward computerization and application of specific software systems for medical equipment management in order to improve their services and monitor outcomes. Recently, much emphasis has been given to patient safety. Through its Medical Device Directives, the European Union has required all member nations to use a vigilance system to prevent the reoccurrence of adverse events that could lead to injuries or death of patients or personnel as a result of equipment malfunction or improper use. The World Health Organization also has made this issue a high priority and has prepared a number of actions and recommendations. In the present workplace, a new integrated, Windows-oriented system is proposed, addressing all tasks of CEDs but also offering a global approach to their management needs, including vigilance. The system architecture is based on a star model, consisting of a central core module and peripheral units. Its development has been based on the integration of 3 software modules, each one addressing specific predefined tasks. The main features of this system include equipment acquisition and replacement management, inventory archiving and monitoring, follow up on scheduled maintenance, corrective maintenance, user training, data analysis, and reports. It also incorporates vigilance monitoring and information exchange for adverse events, together with a specific application for quality-control procedures. The system offers clinical engineers the ability to monitor and evaluate the quality and cost-effectiveness of the service provided by means of quality and cost indicators. Particular emphasis has been placed on the use of harmonized standards with regard to medical device nomenclature and classification. The system's practical applications have been demonstrated through a pilot evaluation trial.