Dedicated To Delivering Accountability, Maximizing Compensation And Facilitating Your Recovery

An Overview of the FDA Death Database Malfunction

On Behalf of | Oct 28, 2019 | FDA Alerts

Researchers have reported that the miscategorization of a slew of patient deaths by the FDA points to the potential unreliability of their adverse events database. Here, the pharmaceutical liability attorneys at The Law Offices of Peter Angelos discuss how current protocols for reporting patient death through the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database may not account for a significant amount of misclassified patient deaths.

The MAUDE Database is a Postmarketing Medical Device Database Used by the FDA

As a method of tracking and reporting patient death and injury, as well as a crucial tool for approving medical devices and systems, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database allows the FDA to surveil the post-market performance of medical devices. While submitting to MAUDE is mandatory for medical device manufacturers, importers and device user facilities, it is voluntary for physicians. Mandatory reporters have the responsibility to submit medical device reports to the publicly accessible database so the FDA can properly manage the approval of new medical devices. MAUDE has three categories—malfunction, injury or death—by which adverse events can be labeled. MAUDE is essential for tracking the adverse events related to certain medical devices in order to understand the safety of certain medical devices as well as the risk.

Research Points to Inaccuracies in MAUDE Database

While MAUDE is one of the most important medical device databases for tracking patient death and injury and recording medical device performance, researchers have reported that the current methods for reporting adverse events are not reliable or accurate. For instance, a significant amount of patient deaths are not accounted for in the MAUDE database and, in many cases, medical reports mistakenly labeled as an injury or device malfunction have used words such as “died” or “passed away” when documenting patient injury.

Specific evidence pointing to the inaccuracies of MAUDE would include the example of Sapien 3 transcatheter aortic valve replacements: approximately 17.5% of patient deaths as a result of these devices were incorrectly documented as a malfunction or injury. In addition, 24.7% of MitraClip mitral valve repairs were also mislabeled. These two instances alone account for 97 injury and malfunction reports that were misclassified.

Investigators State that MAUDE Must Be Improved to Preserve Perceptions of Device Safety

As a result of several reports that demonstrate the imprecision of the MAUDE database, investigators have expressed concerns that the underreporting of deaths will dramatically affect the medical device approval process by the FDA and potentially put patient health at risk. With physicians unable to obtain accurate data regarding the safety and potential risks of medical devices, it is essential for a more accurate approach to be developed in order to accurately collect adverse events. The FDA is currently seeking new and improved approaches for the medical device approval process.

The Attorneys at The Law Offices of Peter Angelos Urge You to Contact Our Baltimore Office Today

Accurate data on medical devices is essential for the FDA to properly gauge the safety of devices and systems in order to approve or reject them for public use. When data collected on adverse medical events does not report the full extent of patient deaths that occur, the outlook regarding the safety of certain medical devices becomes misconstrued. If you or a loved one has been harmed by a medical device malfunction, we urge you to contact the pharmaceutical liability attorneys at The Law Offices of Peter Angelos today.