Reporting Device Adverse Events Challenge

Challenge Background

Medical devices will play an increasingly large role in the monitoring and collecting of patient data with the spread of electronic health records. As patients take a more direct role in managing their health care, devices that are implanted or used in the hospital, clinic, or home must be easy to use and monitor. The reporting of adverse events related to these devices is a logical area to start.
The United States has a limited system for the post-market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. 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: 1.) increase the rate of reporting of adverse events and, more importantly, improve the quality of the reported data; 2.) 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 3.) make the data much more dynamic with continuous updating to identify trends in real-time.

Challenge Description

The “Reporting Device Adverse Events Challenge” asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. This application would:
  • Make it easy for patients to report adverse events that occur with any medical device to their provider, who would then be able to use EMR- or PHR-embedded software (see next bullet) to auto-populate relevant report fields, as well as to add additional EMR/PHR-based text and information relevant to the event, and submit a detailed report to the MAUDE system.
  • Support the download of information from EMR or PHR systems to populate the adverse event report and provide high quality data (note that the application only needs to demonstrate the ability to download data from one or more systems and does not need to be fully integrated across all EMR/PHR platforms).
  • Make it easy for patients and physicians to quickly and easily “register” their devices using browser-based and mobile computing tools, or even handheld barcode readers;
  • Capture useful demographic and other relevant information from each patient including age, gender, race, relevant diagnoses, and following physician;
  • Capture information about the type of device used, the individual who implanted or distributed the device, and where the implantation or distribution occurred; and
  • Be easily accessible to all stakeholders (patients, providers, manufacturers, and researchers) via current technologies including PC-based browsers, mobile phones, and tablets.
  • Leverage and extend NwHIN standards and services including, but not limited to, transport (Direct, web services), content (Transitions of Care, CCD/CCR), and standardized vocabularies.

Judging Criteria

Each submission will be judged according to the following criteria. Winning entries should:
  1. Effectiveness of the system in facilitating adverse event reporting
  2. Usability and design from the standpoint of all stakeholders
  3. Ability to integrate with electronic health records and other data sources
  4. Creativity and Innovation
  5. Leverage NwHIN standards including transport, content, and vocabularies

Submission Criteria


To register for this challenge participants should:
  • Access the ONC Investing in Innovation (i2) Challenge website at:
  • Access the website and search for the “Reporting Device Adverse Events Challenge”.


  • Submission Period Begins: 12:01 AM ET, Monday, September 12, 2011
  • Submission Period for Entries Ends: 11:59 PM ET, Friday, December 2, 2011
  • Judging Process Begins: Monday, December 5, 2011
  • Judging Process Ends: Friday, December 16, 2011
  • Winner notified: Monday, December 19, 2011
  • Winner will demo at a conference in January, 2012

Terms & Conditions