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Food and Drug Administration Communicates About Medical Device Safety

The US Food and Drug Administration issued a notice 35 years ago warning health care providers about the dangers of particular electrically-powered hospital beds, which might damage or even kill children. That was one of our first communications about the safety of medical devices. Since then, one of our primary responsibilities for the 190,000 medical devices that the Food and Drug Administration regulates has been to communicate about device safety. These public statements concerning medical device recalls are essential for safeguarding patients from medical device-related problems and assuring the safety and effectiveness of medical devices.

We work with various professionals in business, health care facilities, and professional societies at the Center for Devices and Radiological Health to ensure that medical device safety risks are swiftly discovered, assessed and communicated appropriately. When it comes to resolving communication issues, we use a human-centric approach that blends empathy, creativity, and critical thinking with patients, carers, and health care providers. This method assists us in better understanding the demands of our audiences and inform and improve our communication methods.

Together with members of the media, these organizations play an essential role in helping to disseminate safety information to the public and lobbying for continuous transparency regarding medical device safety signals and potential hazards. On October 6, 2021, the Food and Drug Administration will convene a Patient Engagement Advisory Committee (PEAC) meeting as part of its continued commitment to ensuring patients receive the correct information at the right time to help them make informed decisions about medical device safety. Theand industry will discuss aspects to consider in successfully communicating medical device recall information to patients and the general public at this meeting.

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