AAMI Standards: A History of Ensuring Medical Technology Quality and Performance

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The origins of medical devices date to prehistory, when primitive blades were used as scalpels (in surgeries such as trepanning) or to insert foreign materials into the human body. While the ages of reason and electricity spurred the transformation of those crude pieces of bone, stone, and wood into a wide array of devices, it was the invention of reliable transistors in the mid-20th century, along with advances in plastics and computing, that ushered in the modern age of medical technology. That modern age brought with it an awareness that medical devices must demonstrably help patients—that they must be both safe to use and effective in treating disease and promoting health.

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