FDA’s MAUDE data and its contribution to medical technology assessment and patient safety

Abstract

The most prevalent medical device markets have adopted vigilance systems for medical devices (MD) as a requirement of their regulatory frameworks[1]. According to the vigilance systems the MD manufacturers are enforced to report to the authorities any adverse event (AE) involving any of their MDs. USA Food and Drug Administration (FDA) has a database for these reports, which receives more than 400.000 reports annually[2]. Some of these vigilance reports lead to corrective actions, with obvious benefits for the patients. However, this huge amount of data is used at a second stage for retrospective analysis and data extraction techniques offering spin-off benefits in terms of patient safety and MD technology assessment.