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FDA Compliance

Meet MAUDE

New interface provides access to FDA database of medical device reports

Published: Tuesday, September 2, 2014 - 16:09

In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but occasionally they 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—short for Manufacturer and User Facility Device Experience. 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. This API will allow developers and researchers to easily query thousands of reports dating back to the early 1990s.

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. For example, it can help identify new, potential safety signals as well as which classes of devices may be associated with particular adverse events.

There are some necessary caveats to this API. The dataset is a record of reports submitted to the 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. It’s 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.

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

By design, openFDA is a research and development project that draws on community involvement. We are actively involved in the openFDA communities on GitHub and StackExchange, and encourage people interested in the project to participate in those communities. Together, we can make openFDA a more useful, more powerful resource for the protection and advancement of the public health.

In addition to providing datasets, openFDA encourages innovative use of the agency’s publicly available data by highlighting potential data applications, and providing a place for communities to interact with one another and with FDA domain experts.

First published Aug. 19, 2014, on FDAVoice.

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About The Authors

Taha A. Kass-Hout’s picture

Taha A. Kass-Hout

Taha A. Kass-Hout serves as FDA’s first Chief Health Informatics Officer, bringing more than 16 years experience in health, public health, and informatics. He has provided long and short-term strategic, operational, and tactical planning activities for the public and private sector. He’s credited with launching the first Department of Health and Human Services (DHHS) program hosted completely in the Internet Cloud, in alignment with the White House Cloud Initiative. Taha holds a Doctor of Medicine degree from the University of Texas Health Sciences Center at Houston, and a Master of Science from the University of Texas, School of Public Health, Department of Biostatistics.

 

 

Jeffrey Shuren’s picture

Jeffrey Shuren

Jeffrey Shuren is the director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy. Shuren received his bachelor’s and doctor of medicine degrees in medical education from Northwestern University under its Honors Program.