Manufacturer and User Facility Device Experience (MAUDE) Database
What is the MAUDE system maintained by the FDA? MAUDE stands for the Manufacturer and User Facility Device Experience. This is a tool the U.S. Food and Drug Administration provides to monitor medical devices. That makes it a valuable resource for the medical community.
MAUDE offers a localized database for passive postmarket surveillance of medical devices. If you work in a healthcare environment, manufacture and design medical devices or distribute them, then you need to know more about the MAUDE database.
What is the MAUDE Database For?
The MAUDE database compiles Medical Device Reports, MDR, sent to the FDA. It is a searchable database available online to medical professionals and the public. The data in the database consists of reports provided to the FDA about a malfunction of a medical device. In some cases, the malfunction may cause injury or death.
Who Uses the MAUDE Database?
Technically, anybody can use the database. The online search form is available to the public. Submission of medical device reports is controlled, however. The database is made up of mandatory MDR forms submitted to the FDA by:
- Device Users
Manufacturers, importers and users are required to submit a report to the FDA once they become aware of a potential problem with a device. The FDA houses these reports in the MAUDE database.
What MAUDE Is Not?
MAUDE is not a comprehensive list of adverse events involving medical devices. The information on MAUDE is unverified and potentially biased. For one thing, the report is limited to what the person filling out the form submits. The reporter may leave out valuable information or misreport significant details. Personal information is redacted, as well, so follow up is difficult.
MAUDE is not a real time database, either. The FDA updates the program once a month, usually around the sixth.
MAUDE may have redundant reports regarding one event, as well. There is no curator of this system, so one device may appear to have multiple events, but there is really just one with many reports.
Benefits of the MAUDE Database
Although, the database is not perfect, it does offer real benefits to the medical community. MAUDE is the only surveillance system that covers medical devices marketed in the U.S. Other benefits include:
- It offers the largest number of case reports regarding adverse outcomes for medical devices.
- It offers medical professionals a way to find rare and unusual adverse clinical outcomes related to a device.
- It provides a narrative section that allows the reporter to describe the event, so readers get a better understanding of the circumstances behind the adverse outcome.
MAUDE is a starting point for those researching medical devices. It helps you develop hypotheses, but is not confirmation of a problem. The search site states details taken from this database is not safety information or in any way conclusive.
It is a study tool that allows you to parse out information regarding a specific device. That is helpful for facilities considering stocking something new or one that is investigating an adverse outcome and suspect the device to be the cause.