Spin-off use of adverse events data: why and how. The case of FDA’s MAUDE

Main Article Content

Panagiotis Malataras, Dr.
Nicolas Pallikarakis, Prof.


Medical Devices, MAUDE, Adverse Events Reports, Patient Safety, Health Technology Assessment


Objectives: This paper attempts to measure the impact of the second stage exploitation of FDA’s MAUDE database on patient safety, technology assessment and other scientific fields.


Methods: Five bibliographic databases have been queried with the terms “Manufacturer and User Facility Device Experience Database” and “FDA AND MAUDE”. A number of eligibility criteria where applied on the results, which led to a final group of 117 papers. An extensive study of these publications resulted to a number of interesting findings.


Results: The results concern the evolution of the database exploitation over time, and are examined according to the device groups that the identified papers are referring to, the research goals of these papers, the reasons that led the authors of these papers to use MAUDE data and finally how these data were used within their research methodology.


Conclusions: Patient safety and technology assessment are two of the scientific fields on which MAUDE database has the greatest impact. On average, more than 10 peer-reviewed papers each year involve MAUDE data as a mean to reach their research goals. This proves that MAUDE is an exploitable and valuable data source for research in these scientific fields.


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