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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The Food and Drug Administration has scheduled a hearing in response to public concerns about Essure, a nonsurgical, permanent female sterilization device. Since FDA approved the product in 2002, the agency has received reports on 5,093 adverse events, including six deaths. The hearing coincides with a landmark event for medical device safety: the compliance date requiring that all... Read More
Patients rely on medical devices to replace failing joints, fix irregular heart rhythms, test blood sugar, unblock clogged arteries, diagnose disease, and improve their health in other ways. Yet for many years these devices have lacked industrywide standard identification numbers, a shortcoming that hinders hospital efforts to track inventory, prevents physicians and patients from having complete... 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