FDA Releases Device Adverse Event API
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.
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.
Currently, this data covers publicly releasable records submitted to the FDA from about 1992 to the present. The data is updated weekly.
The API, which provides a way for software to interact directly with the data, will allow developers and researchers to easily query thousands of reports dating back to the early 1990s, according to Taha Kass-Hout, M.D., the FDA's chief health informatics officer.
"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."
Kass-Hout also said the tool has some caveats: The dataset is a record of reports submitted to FDA, and 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. And the appearance of a device in a report does not mean that cause-and-effect has been determined.
Therefore, these data should be used in the context of other available information. Its also important to note that the data made available under this initiative do not contain anything that potentially could be used to identify individuals or reveal other private information.
The tool is available here.
Currently, this data covers publicly releasable records submitted to the FDA from about 1992 to the present. The data is updated weekly.
The API, which provides a way for software to interact directly with the data, will allow developers and researchers to easily query thousands of reports dating back to the early 1990s, according to Taha Kass-Hout, M.D., the FDA's chief health informatics officer.
"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."
Kass-Hout also said the tool has some caveats: The dataset is a record of reports submitted to FDA, and 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. And the appearance of a device in a report does not mean that cause-and-effect has been determined.
Therefore, these data should be used in the context of other available information. Its also important to note that the data made available under this initiative do not contain anything that potentially could be used to identify individuals or reveal other private information.
The tool is available here.