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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Under federal policies proposed in January, researchers, medical product innovators, and clinicians will gain unprecedented access to Medicare data that the Obama administration says will facilitate “smarter and more informed” health care decisions. Read More
On March 29, The Pew Charitable Trusts submitted comments to the Centers for Medicare & Medicaid Services (CMS) about the agency’s proposal to expand access to Medicare claims data for qualified entities. The comments point out that until claims contain information on the devices used in care, the qualified entity program and other CMS initiatives to harness claims data will be missing... Read More
New findings from Medicare’s independent auditor indicate that faulty medical implants—such as cardiac pacemakers and artificial joints—are harming seniors and costing taxpayers billions of dollars. According to the Department of Health and Human Services inspector general, the solution is a step recommended by patient safety experts and the Food and Drug Administration:... Read More