Abstract
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.
Highlights
Patient safety, health technology assessment and medical device vigilance are fields that heavily rely on data availability
The last step was to study again in more detail the final group of these 117 papers, focusing on the device groups that these papers referred to, the evolution of the database exploitation with time, the research goals of these papers, the reasons that led the authors of these papers to use Manufacturer and User Facility Device Experience (MAUDE) data, how they used these data within their research methodology, etc
The analysis of the final set of 117 papers revealed the following: A) Since MAUDE is a database containing medical device reports (MDRs), each record is related with a medical device
Summary
Health technology assessment and medical device vigilance are fields that heavily rely on data availability. They need valid data from various sources in order to extract useful information. A significant source of data for medical devices (MDs) appears to come from the medical devices vigilance and post-market surveillance mechanisms that are imposed by the relevant regulatory systems, in most part of the world. Millions of medical devices are used today in various places (hospitals, clinics, houses, etc.) and thousands of new models enter the market every year. These MDs have a significant contribution to the improvement of the healthcare services provided. There are numerous cases where devices have been recalled because of their involvement in adverse incidents compromising patients’ health or cases where a “promising” innovative approach has to be withdrawn after a
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