FDA Unveils API for Medical Device Adverse Event Data

August 20, 2014 in News

FDA has expanded its openFDA initiative to include an application programming interface that enables users to query medical device adverse event reports, Clinical Innovation Technology reports (Walsh, Clinical Innovation Technology, 8/19).

Background

In June, FDA launched openFDA to ease the process for researchers, health IT developers and consumers to access the agency’s trove of public health data. FDA developed the tool in response to a recent presidential executive order to make federal data more accessible to the public.

Specifically, the tool offers FDA data in a structured, computer readable format, allowing individuals to:

  • Search data; and
  • Pull large amounts of data (iHealthBeat, 7/21).

Details of API

The new API will use FDA’s Manufacturer and User Facility Device Experience, which contains medical device adverse event reports submitted to the agency since 1992. The data are updated weekly (Goth, Health Data Management, 8/19).

In a blog post, Taha Kass-Hout, chief health informatics officer and director of FDA’s Office of Informatics and Technology Innovation, and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said the API can help flag categories of devices that might be associated with certain adverse events and other safety signals. They wrote, “The API can be a powerful tool for generating hypotheses for further investigation or inquiry and can inform the development of safer, more effective technologies” (Kass-Hout/Shuren, FDA Voice, 8/19).

However, they noted that there are some limitations. Specifically, they warned that the dataset only includes adverse events reported to FDA, meaning it could contain data that are:

  • Biased;
  • Incomplete;
  • Inaccurate; or
  • Unverified.

Kass-Hout and Shuren also wrote that a device being listed in the dataset does not mean that cause-and-effect has been determined.

Therefore, they noted that researchers should use the data in the context of other public information (Health Data Management, 8/19).

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