Shrnutí

Popis

SUMMARY DDOD use case request for consolidated, consistent reporting of medical device recalls. WHAT IS A USE CASE? A “Use Case” is a request that was made by the user community because there were no available datasets that met their particular needs. If this use case is similar to your needs, we ask that you add your own requirements to the specifications section. The concept of a use case falls within the Demand-Driven Open Data (DDOD) program and gives you a formalized way to identify what data you need. It’s for anyone in industry, research, media, nonprofits or other government agencies. Each request becomes a DDOD use case, so that it can be prioritized and worked on. Use Cases also provide a wealth of insights about existing alternative datasets and tips for interpreting and manipulating data for specific purposes. PURPOSE This use case was requested with the goal of obtaining a "single source of truth" for medical device recalls, rather than trying to reconcile between the two data sources. It needs to: Provide unique recall ID to link data from these two sources. Provide standardized, consistent product name or registered device key (such as PMA # or 510(k) #) VALUE The value of the use case is to helps hospitals more effectively catch devices in their inventory that have been recalled and prevent them from buying potentially unsafe ones. It improves outcomes and patient safety by lowering probability of hospitals being unaware of devices have been recalled. USE CASE SPECIFICATIONS & SOLUTION Information about this use cases is maintained in a wiki: http://hhs.ddod.us/wiki/Use_Case_6:_Consolidated_reporting_of_medical_de... It serves as a knowledge base. USE CASE DISCUSSION FORUM All communications between Data Users, DDOD Administrators and Data Owners are logged as discussions within GitHub issues: https://github.com/demand-driven-open-data/ddod-intake/issues/6 It aims to provide complete transparency into the process and ensure the same message gets to all participants. CASE STATUS Closed via openFDA.gov API, which includes medical device recall information as of September 2015.