Bioartificial Liver Devices
A liver support system or diachysis is a type of Medical device, therapeutic device to assist in performing the functions of the liver. Such systems focus either on removing the accumulating toxins (liver dialysis), or providing additional replacement of the Metabolism, metabolic functions of the liver through the inclusion of hepatocytes to the device (bioartificial liver device). A diachysis machine is used for acute care i.e. emergency care, as opposed to dialysis machinewhich are typically used over the longer term. These systems are being trialed to help people with acute liver failure (ALF) or acute-on-chronic liver failure. The primary functions of the liver include removing toxic substances from the blood, manufacturing blood proteins, storing energy in the form of glycogen, and secreting bile. The hepatocytes that perform these tasks can be killed or impaired by disease, resulting in acute liver failure (ALF) which can be seen in person with previously diseased liver or ...
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Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ...
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