ISO 14971 as a methodological tool in the validation process of a RIS-PACS system

The utilization of medical devices includes prevention, diagnosis and treatment of disease. Despite the many benefits, devices also can lead to potential adverse effects. As a result, standards have been implemented to protect both the patients and medical staff against harmful effects and support the manufactures in the validation process for clinical use. From this point of view, also the integrated RIS (Radiology Information System) - PACS (Picture Archive and Communication System) system requires a detailed risk analysis in the validation and installation process. Actually, there are no specific standards that provide a clear classification of such systems and therefore a methodology for the risk assessment is not defined. To this aim and to ensure an optimal validation and installation phase and test choice, we considered the international standard ISO 14971 and we introduced a failure modes, effects and criticality analysis technique (FMECA) to classify the occurrence, the severity and impact of all possible failure modes on the RIS-PACS system. This helps to eliminate or reduce the impact of potential erroneous system behavior before the completion of the installation and the optimization of the test on the field to validate the system under examination.