Health 2.0 and the Office of the National Coordinator for Health Information Technology (ONC) have announced the winner of the Investing in Innovation initiative's (i2) Reporting Device Adverse Events Challenge. The i2 initiative utilizes prizes and challenges to facilitate innovation and obtain solutions to intractable HIT problems. Aligned with the Obama administration's innovation agenda, it is the first federal program to operate under the authority of the America COMPETES Reauthorization Act.
The challenge—which launched on September 12, 2011—called attention to adverse events related to medical devices. With the spread of EHRs, medical devices will continue to play increasing roles in monitoring and collecting patient data. As patients play larger roles in managing their health, the devices that are used in hospitals, clinics, and homes must become easier to use and monitor. The United States has a limited system for the postmarket surveillance of medical devices, specifically as relating to monitoring product safety and effectiveness. The US Food and Drug Administration operates the Manufacturer and User Facility Device Experience (MAUDE) database, which catalogs reports of adverse events involving medical devices used in a variety of settings.
In order to improve the postmarket surveillance of medical devices, it is important to innovate beyond the MAUDE database. ONC identified a need for a system that increased the rate of reporting of adverse events, improved the quality of the reported data, collected and analyzed information on providers using devices and patients receiving the devices and makes the data more dynamic and continuous to identify trends in real-time. The Reporting Device Adverse Events Challenge tasked teams with creating applications to meet these needs.
"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," says Wil Yu, special assistant for Innovations at ONC.
As the winner, Team IOSTREAM will receive $25,000 in prizes. A brief summary of the winning application follows:
IOSTREAM—submitted by Doug Brown—the MedDAERS system by IOSTREAM is a Web-portal for health professionals and consumers to voluntarily report the adverse events, product problems, and product use errors associated with medical devices. Submitted reports are converted into electronic versions of the MedWatch 3500 form. The website has two entry points—the first is for users who wish to fill out and submit voluntary reports, the second is those with login credentials and is used to view the XML formatted voluntary reports that have been submitted.
To learn more about the Reporting Device Adverse Events Challenge, visit the Challenge's website (www.health2con.com/devchallenge/reporting-device-adverse-events-challenge/).
Source: Health 2.0