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 Pew Charitable Trusts submitted comments Wednesday, August 12, on the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2018 through 2022. Read More
New research from Avalere Health LLC illuminates a number of key barriers to the collection of critical data by medical device registries. The report, Innovative Approaches to Accessing, Extracting, and Aggregating Electronic Health Data: Experience From Five U.S. Medical Device Registries, was based on interviews with the featured registries, and an analysis of the findings, to identify common... Read More
Pew Applauds 21st Century Cures Act’s Antibiotic Resistance, Substance Abuse, Medical Device Provisions
The U.S. House of Representatives today passed the 21st Century Cures Act, a wide-ranging bipartisan health bill. Pew—along with FDA, large hospital systems, surgeons, patients, and other key health care stakeholders—have all supported the inclusion of these identifiers in patients’ health records. 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