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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The current system for evaluating implanted medical devices provides inadequate information on theperformance of the products used. This hinders prompt identification of failures and often requires lengthy andcostly studies to investigate technologies both before and after approval. Better integration of medical records,registries, and other data sources would ensure that the Food and Drug... Read More
The Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) have joined forces to push to include the codes—known as unique device identifiers (UDIs)— in Medicare claims. Read More
In July, Medicare proposed a new initiative to lower costs and improve care for seniors who receive treatment for a heart attack or are at high risk for having one. Unfortunately, this program misses an opportunity to gather critical information that could help protect the safety of millions of patients who rely on medical implants. Read More