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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.
On Sept. 20, the U.S. Food and Drug Administration issued final UDI regulations that will help improve the quality and safety of care for patients that rely on medical devices. Pew urges policymakers and the private sector to encourage the use of identifiers in clinical practice by including them in patients’ medical records and insurance claims.
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