FDA offers API for medical device adverse events
Under its openFDA project, the agency has released a new API that allows users to query medical device adverse event reports dating back to 1992.
Manufacturer and User Facility Device Experience (MAUDE), is the FDA dataset containing the data which is updated weekly.
“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,” wrote Taha Kass-Hout, MD, the FDA’s chief health informatics officer, 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.”
Despite the potential, Kass-Hout warned of the tool’s caveats. The dataset is a record of reports submitted to the FDA--not a definitive accounting of every incident. Because it may contain incomplete, inaccurate, unverified or biased data, it cannot be used to determine incidence. Plus, the appearance of a device in a report does not mean that cause-and-effect has been determined.
Researchers and other users should use these data 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,” wrote Kass-Hout. “We believe that these tools can be used by developers and researchers to make insights that fuel new, innovative products (such as mobile apps and websites), and that help protect and promote the public’s health.
The tool is available here.
Editor
Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.