Developing a Dynamic Register of Security Quality and Maintenance for Medical Devices

Abstract

The traceability of operating actions of medical devices requires a management system under the responsibility of biomedical professionals who need to check multitude information about each action in a stage of the medical device life cycle. This system was always a «static» register of security quality and maintenance (RSQM). With the RSQM, the usual strategies performed for medical devices in hospitals have difficulties in the identification of specific risks and optimal implementation of risk reduction activities. This work proposes a "dynamic" register of security quality and maintenance (RDSQM) to correct the limitations of conventional RSQM. The RDSQM has ten folios. It is a flexible tool that can be used in computer network and will also improve the daily work in biomedical/clinical engineering.