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.
Advancing innovation and patient safety
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Recent, high-profile device failures demonstrate the need for better information on the postapproval performance of medical devices used in clinical care. Medical device registries, which collect information on patients treated with specific products, are being used to solve this problem. Read More
A pilot project to integrate unique device identifiers (UDIs) into hospital inventory systems and patients' medical records helped improve safety, enhance care quality, and support operational efficiencies. If adopted more broadly, the UDI system can benefit the entire health care system. Read More
An event co-hosted by the U.S. Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and The Pew Charitable Trusts