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Project

Medical Device Initiative

Status:
Active

Medical Device Initiative

Project Contact

Linda Paris Manager, Communications, Medical Programs Tel: 202-540-6354
Email:

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. 

Such items are an essential part of patient care, but severe consequences can result if a defective or unsafe one enters widespread use. Failures of medical devices in the past two decades demonstrate the need for more rigorous and timely oversight of these products to help ensure the safety of the public.

For instance, life-threatening failures of the electrical leads in implantable cardioverter defibrillators—used by hundreds of thousands of people to detect and correct abnormal heart rhythms—resulted in several recent recalls. Studies point to such failures as evidence of deficiencies in FDA’s postmarket surveillance system for medical devices which is charged with monitoring the continued safety and effectiveness of approved products.

Pew’s medical device initiative is working to strengthen this system. Among other efforts, Pew has supported the development and use of unique device identifiers, or UDIs, to mark medical products or their labels with a code corresponding to the products’ make, model, and other clinically relevant information. 

Precarious Medical Devices in Use

Precarious Medical Devices in Use Media Coverage

Pew's Josh Rising writes about how the FDA classifies some devices as high risk but that hundreds of other potentially high-risk medical devices remain in use without adequate testing.

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National Postmarket Surveillance Plan

National Postmarket Surveillance Plan Issue Brief

Pew commends the FDA for highlighting the importance of a unique device identifier system and registries and to offer additional recommendations to further this plan.

Full Story