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 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 past decades have demonstrated 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 worked to enhance medical device safety and foster device innovation that benefits patients. Pew’s initiative had 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.
- Fostering medical device innovation with these and other new approaches without compromising patient safety.
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The Pew Charitable Trusts and several health organizations, hospital systems, and medical device manufacturers sent a letter on May 17 to Scott Gottlieb, the commissioner of the Food and Drug Administration, and Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, urging them to continue their agencies’ support for efforts to add unique device identifiers... Read More
A key advisory committee today recommended changes to enable the standard health insurance claim form to record the identifying codes for implanted medical devices—something long sought by hospitals, providers, health plans, and patient organizations. The X12 committee, made up of hospital and health plan billing administrators, proposed the revisions to the routine claims forms that... Read More
Pew submitted comments on Oct. 25 to the Food and Drug Administration in response to its draft guidance on the use of real-world evidence to inform regulatory decision-making for medical devices. Pew supports two key policy changes: the incorporation of unique device identifiers into relevant real-world data sources like claims forms so that potentially faulty devices can be tracked; and the... Read More