FDA beefs up medical device adverse event data through API

The U.S. Food and Drug Administration is expanding the data available on medical device-related adverse events and recalls through its OpenFDA initiative, according to a blog post at FDA Voice.

The new data available through OpenFDA's Application Programming Interface (API) includes 6,000 device classification records, 24,000 registrations of device companies and establishments, and the companies' listings of more than 100,000 devices, write Taha A. Kass-Hout, M.D., chief health informatics officer and director of FDA's Office of Health Informatics; Roselie A. Bright, manager of OpenFDA; and Ann M. Ferriter, FDA's Director of Analysis and Program Operations in the Office of Compliance at the Center for Devices and Radiological Health.

The agency unveiled the API in July 2014 as a new way to access FDA data--it already provided it through including an RSS feed, a Flickr stream and a search interface.

The API was designed to be a common platform where developers could integrate data from various sources and build their own applications.

The information available through the API now includes data since 1976 on 30,000 device premarket approvals and approval supplements, and 141,000 device clearances through premarket notifications known as 510(k)s, according to the post. In addition, it offers 9,500 records going back to 2002 on device recalls because of 4.2 million adverse event reports since 1991.

The post's authors, however, warn of some limitation to the data. Searches might not capture all records, for instance, if the name of a manufacturer is listed with different spellings or variations on a name. The types of information that FDA has collected has changed over the years, which can make it difficult to look at data over time. And there might be insufficient data to establish cause and effect, incidence, or prevalence, they write.

The FDA's action was part of a federal open data initiative begun in 2013. More than 115,000 data sets across the federal government have been made available to the public since then.

California has started a similar initiative with a data portal running on the website for the California Department of Health in hopes of finding gaps and issues that need to be fixed in state's health systems.

To learn more:
- read the blog post