Medical Devices Vigilance, «Matériovigilance», as an Actor of the Hospital Safety Culture

Abstract

The safety culture of a hospital is made up of all the healthcare givers’ thoughts and know-how. It aims to be able to anticipate and manage the planned, and to adapt to the unexpected in order to ensure the patient safety and care. The medical devices (MD) usage depends on the technical knowledge and on the training to proper use. The errors of MD’s use are the main source of MD’s vigilance – “materiovigilance” – reported incidents. These reports are experiences’ feedback that allow to identify and analyze the root causes of incidents, more particularly the failing organizational and human factors. Committee of experiences’ feedback, that is multidisciplinary, examines causes and effects of past incidents according to two methods: the ALARM (Association of Litigation and Risk Management) method and the Case-Effect diagram (Ishikawa diagram). The goals are to share experiences to enrich skills, and, to get solutions and improvement actions’ plan. The “materiovigilance” fits the safety culture, encouraging the capitalization of the common knowledge. It is a source of informations on the MD’s dysfunctions thanks to the collection, the traceability and the treatment of incidents’ reports. The safety culture common project needs individual and collective involvement, at each hierarchical level. This way, safety culture and “materiovigilance” participate to the ongoing healthcare improvement and the global performance of a hospital.