FDA Releases Device Adverse Event API

By Christine Kern, contributing writer

A new interface will help to identify devices associated with adverse events.

Under its openFDA project, the U.S. Food and Drug Administration has released a new application programming interface that returns data from its Manufacturer and User Facility Device Experience (MAUDE), an FDA dataset that contains medical device adverse event reports.

In addition to food and drugs, FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. Occasionally these devices present a safety issue due to risks not identified in prior studies, a malfunction, a problem with manufacturing, or misuse.

These incidents are collected in a publicly available FDA database called MAUDE. As part of the openFDA project, there is now an Application Programming Interface (API) for this dataset, which provides a way for software to interact directly with the data, allowing developers and researchers to easily query thousands of reports dating back to the early 1990s.

While the dataset is a record of reports submitted to FDA, it is not a definitive accounting of every incident with every device. It may contain incomplete, inaccurate, unverified, or biased data. Thus, it cannot be used to determine incidence. Further, the appearance of a device in a report does not mean that cause-and-effect has been determined. Data therefore should be used only in the context of other available information.

This API is the latest in a series of openFDA releases that have made publicly available data more easily accessed and queried. Over the last two months, openFDA has released several APIs related to drugs, food, and devices. Together, they help provide perspective on the work FDA is doing, and make the public health data the agency is developing easier to access and utilize.

"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 said in a blog post announcing the API's availability. "For example, it can help identify new, potential safety signals as well as which classes of devices may be associated with particular adverse events."

The tool is available here.