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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On July 22, Josh Rising, director of Pew’s medical device initiative, testified before the U.S. House Energy & Commerce Committee, Subcommittee on Health, where he discussed how registries can help decrease the time and cost of clinical trials without sacrificing the collection of data on safety and effectiveness. Read More
On Tuesday, July 22, The Pew Charitable Trusts submitted comments on two draft guidance documents from the U.S. Food and Drug Administration designed to expedite patient access to new medical devices. Read More
The U.S. Food and Drug Administration, hospitals, manufacturers and patients have lacked the needed information to quickly identify problems with medical devices and quickly remove those products from the market. As a result, the FDA in 2013 issued final regulations that will require medical device labels to bear a distinctive code—called the unique device identifier, or UDI—to help... Read More