HealthIT Answers October 21, 2021
By Michelle Tarver, M.D., Ph.D., Deputy Director, Office of Strategic Partnerships and Technology Innovation; Program Director for Patient Science, Digital Health Center of Excellence, Center for Devices and Radiological Health and Angela Calman, M.P.A., Director, Office of Communication and Education, CDRH, FDA
Thirty-five years ago, the U.S. Food and Drug Administration issued an alert that warned health care providers how certain electrically powered hospital beds could harm and even kill children. That was one of our earliest communications about medical device safety. Since then, communicating about medical device safety has been one of our core responsibilities for the 190,000 medical devices that we regulate at the FDA. These public communications, many of which are about medical device recalls, are critical...
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