Pilot Study of a Reporting System for Serious Adverse Events Related to Healthcare (SAE)

Under the Act of August 9, 2004, the French Institute for Public Health Surveillance (InVS) conducted a pilot study to test and evaluate a system for reporting SAEs. The objectives were: (1) to establish a system for reporting these SAEs, with a view to enabling the health authority to issue alerts and take action, if necessary, to prevent recurrence and limit their effects, (2) to test the feasibility, relevance, and effectiveness of such a system in terms of improving patient safety, (3) to identify the conditions and procedures for its widespread implementation. [...]