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Medical Device Failures

“Medical devices” include everything from highly sophisticated, computerized medical equipment to the wooden tongue depressor. In 1938, when the Federal Food, Drug and Cosmetics Act was passed, medical devices were, for the most part, simple instruments such as stethoscopes and scalpels in which any defects would be visible. As technology has evolved, medical devices have become more complex, ranging from pacemakers, heart bypass machines, orthopedic implants, coronary stents, dialysis machines, vascular grafts, and mechanical heart valves.

Problems that can arise with use of medical devices include mechanical failure, faulty design, poor manufacturing quality, adverse effects of materials implanted in the body, improper maintenance/ specifications, user error, compromised sterility/shelf life and electro-magnetic interference among devices.

Medical device manufacturers conduct clinical evaluations of their products both prior to approval and after a device is on the market to evaluate the safety and effectiveness of the device in order that the product be approved for marketing to the general public. For any device.    

Sometimes, however, product defects are discovered long after the device has been placed on the market. When a device failure occurs, physicians and healthcare providers are required to report the product failure to the FDA. As a result, the public may become aware of a trend related to injuries or death caused by a medical device failure. This information may become available through the news or, in the case of implanted devices, patients may be contacted directly by the product manufacturer. In such cases, if there has been an injury or death caused by a medical device failure, a detailed investigation of the product and medical record review is recommended in order to evaluate a claim.

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