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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Medical device failures can be debilitating and life-threatening for patients, especially when faulty technologies are not quickly identified and removed from the market. A new system developed by the Food and Drug Administration, or FDA, will help patients, clinicians, and hospitals spot problems more readily and make real- time assessments on the performance of devices used in patient care. Read More
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On Tuesday, July 22, The Pew Charitable Trusts submitted comments on two draft guidance documents from the U.S. Food and Drug Administration designed to expedite patient access to new medical devices.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