Comparing the EU and USA Medical Devices Vigilance Systems Transparency

摘要

Five international bibliographic databases were queried with search terms relevant to adverse events reports involving medical devices and vigilance systems. The aim was to find the literature papers that have used this kind of data for their research purposes. The papers that have used data from the FDA and the EU vigilance systems for medical devices were analysed separately. The ultimate goal was to compare the usage of the data submitted to each system for further analysis as well as to investigate how the differences of the data access policy (the one of these systems provides open access to its data while the other does not), affects their second stage analysis and their usage by other scientific fields.