Medical devices range from blood glucose test strips and stethoscopes to more complex products, such as pacemakers and joint replacements. These technologies are used in hospitals, doctors’ offices, and in patients’ homes to diagnose, treat, or prevent illness. Many people have benefited from such recent advances, and Americans increasingly rely on medical devices.
However, failures of medical devices over the past two decades demonstrate the need to more quickly identify problems to help ensure the safety of the public. For example, failing metal-on-metal hip replacements and implantable cardioverter defibrillator leads—used by hundreds of thousands of people to detect and correct abnormal heart rhythms—have led to significant patient harm and deaths in recent years.
Pew’s medical device initiative seeks to enhance medical device safety and foster device innovation that benefits patients. Pew’s initiative has three main areas of focus, including:
- Improving the current state of medical device registries—databases containing information on patients who use or are treated with a specific device;
- Supporting the adoption of a unique device identification (UDI) system to better track medical devices; and
- Fostering medical device innovation with these and other new approaches without compromising patient safety.
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Patients rely on the Food and Drug Administration to ensure the safety and efficacy of new medical devices. But the country lacks a robust system for assessing their safety and effectiveness. Read More
Three organizations proposed wide-ranging recommendations on the development of registries to address the country’s lack of a robust national system for assessing the safety and effectiveness of medical devices. Read More
On Tuesday, August 12, The Pew Charitable Trusts submitted comments to Senate Finance Committee chair Ron Wyden and senior Finance Committee member Chuck Grassley on the use of health data to better understand the effect of new medical products on patient outcomes. Read More