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Serious Adverse Events in France: a Reporting and Learning System

Web page - Posted on Jan 28 2021 - Updated on Nov 22 2021

In France, reporting serious adverse events related to health care (SAE-HC) is mandatory since 2002. The French monitoring and health safety system was built over several years with successive strata and in response to health crises. Importantly, reporting SAE-HC and safety culture in healthcare remain underdeveloped. The last two French crises (Mediator®, PIP® prosthesis) have highlighted the need to review the organization of the vigilance system, from the reporting of incidents to their operational management.

The French Ministry of Health has decided to implement a single on-line platform for reporting adverse health events (signalement-sante.gouv.fr). It has been operational since March 2017 and allows reporting SAE-HC and also adverse events associated with the use of a drug, product or device. It also allows patients, carers or family members to declare any events themselves.

The French National Authority for Health (HAS) is in charge of collecting and analyzing data on SAE-HC to give practical recommendations for improving patient safety at a national level.

The SAE-HC notification process is built on 2 levels (cf. diagram 1) with specific features: 

  • the regional level: a first brief description transmitted to the regional health agencies for implementing immediate actions; then a second more detailed description with a systems approach in order to identify causes and barriers. Independent regional and professional structures carry out training actions and can help professionals to complete SAE-HC notifications ;
  • the national level: a permanent committee of 22 experts (selected by the HAS) who help analyze SAE-HC notifications and provide feedback based on their own professional experience. The HAS sets up risks studies and publishes educational stories, practical safety tools and annual reports.

At both levels, the objective is to share and communicate on feedback by grouping similar SAE-HC into specific types of risk situations.

SAE-HC French notification process

 

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