Collecting reports of adverse events with medical devices is critical for both regulators and industry, yet the current regimen has significant drawbacks including under-reporting and inconsistent quality of submissions. Thus the genesis of the Reporting Device Adverse Events Challenge.
The winner was just announced: Team IOSTREAM’s MedDAERS system, which uses a web portal to report adverse events, errors and problems with medical devices. The winners received $25,000, an opportunity to demonstrate the app at an upcoming industry conference and two free passes to the Health 2.0 spring conference.
The US Food and Drug Administration (FDA) operates the Manufacturer and User Facility Device Experience (MAUDE) database, which catalogs reports of adverse events involving medical devices used in all settings going back to 1991.
Although MAUDE includes a wealth of data, the passive surveillance used to collect the data has a number of limitations.
First, as is typical of other passive systems, variable and significant underreporting of adverse events is common. Second, submitted data is highly variable in quality and is largely de-identified, making it difficult to analyze trends on a patient or provider level. Finally, MAUDE data is updated only on a monthly basis, which makes real-time tracking of adverse events impossible and delays the recognition of emerging device issues.
In order to improve the post-market surveillance of medical devices it is important to innovate beyond the MAUDE database concept.
In particular, a system is needed that would:
- increase the rate of reporting of adverse events and, more importantly, improve the quality of the reported data;
- collect and analyze more information that characterizes both patients receiving medical devices and the providers distributing or implanting those devices to make it possible to identify trends better; and
- make the data much more dynamic with continuous updating to identify trends in real-time.
The MedDAERS system enables health professionals and consumers to voluntarily report adverse events, product problems, or product use errors associated with medical devices.
“This was one of our most technically difficult i2 Challenges. We commend the participating teams for their efforts and encourage them to continue to work on their products after the Challenge,” said Wil Yu, Special Assistant for Innovations at ONC.
Download the IOSTREAM slidedeck at the challenge website and view the team’s YouTube video summarizing their MedDAERS system below.