Daily practice of medical device surveillance

In France the manufacturer, the user of a medical device and all those info rmed of an event or a risk for an event caused by the device and resulting in death or the deterioration of the health status of a patient must declar e the event without delay to the appropriate administrative authority. The witness of the event informs either the local correspondent for materiovigi lance, when available, or the ministry directly. A major objective of the l ocal correspondent is to act as a filter and to select among the declaratio ns of events those to be transmitted without delay or quarterly to the mini stry, and those to be registered only locally. Within 48 hours the ministry : a) returns an acknowledgement with instructions how to proceed with the i nvolved device; b) communicates the declaration to the chairman of the ad h oc subcommission; c) informs the manufacturer of the device. The chairman d ecides on the degree severity (major event requiring an immediate investiga tion, event requiring an investigation, event to be entered in a follow-up programme). In the first two cases an investigation is undertaken by one or several members of the subcommission in co-operation with the manufacturer and the declarant of the event. Conservative measures can be undertaken to prevent the re-occurrence of an event either with the involved and/or with similar devices and to facilitate the investigation. (C) 1999 Elsevier, Pa ris.