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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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
On June 11, The Pew Charitable Trusts joined several leading health systems, clinicians, and public health advocacy groups in a letter to Representative Kevin Brady (R-TX) thanking him for his commitment to improve health care quality and patient safety through the U.S. Food and Drug Administration’s unique device identifier system. This system can help generate better data on the millions... Read More
Pew’s Comments on Proposed Rules for Meaningful Use Stage 3, 2015 Electronic Health Record Certification Criteria
The Pew Charitable Trusts—in coordination with eight leading health care groups—submitted comments Friday, May 29, on the proposed regulations for Meaningful Use Stage 3 and 2015 Electronic Health Record Certification Criteria. 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