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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Pew submitted comments on Oct. 25 to the Food and Drug Administration in response to its draft guidance on the use of real-world evidence to inform regulatory decision-making for medical devices.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
A new analysis of data on patients who received one of the seven models of cardiac implants that failed or were recalled found a $1.5 billion cost to Medicare. This eye-opening amount makes a strong case for better tracking of medical devices through Medicare claims forms, which could help detect device failures quickly to minimize the harm to patients and control costs. Read More
Although the United States has invested tens of billions of dollars to encourage providers to adopt electronic health records (EHRs), many clinicians have found that these systems have poor “usability.” EHRs can put patients at risk of medical error, do little to enhance clinical care, and increase the time clinicians spend documenting patient care. Read More