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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Pew Submits Letter to Health and Human Services Regarding Unique Device Identifier Capture in Electronic Health Records
On Tuesday, January 20, The Pew Charitable Trusts submitted a letter to HHS Secretary Burwell asking that forthcoming rules on electronic health record certification and Meaningful Use programs include provisions that allow and encourage providers to document specific medical devices implanted in patients. Read More
Experts from hospitals, health plans, health technology developers, medical device manufacturers, and other health care stakeholders convened December 9, 2014 to discuss the importance of medical device identification. The result: a clear message that a new tool to track medical devices can improve patient safety and the quality of care, but changes in health data systems must occur for this to... Read More
United States senators Elizabeth Warren and Charles Grassley authored a letter to the Centers for Medicare & Medicaid Services seeking the implementation of the new medical device identification system into electronic health information, which is supported by The Pew Charitable Trusts. 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