Organ Care System
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Organ Care System
The Organ Care System (OCS) is a 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 assura ... designed by Transmedics to allow donor organs to be maintained for longer periods of time prior to transplant. The system mimics the elements of human physiology and keeps organs in an environment and temperature similar to the human body. The system allows for organ preservation that last longer than the standard organ preservation method of putting organs on ice, static cold storage, which can cause cold ischemia. When put on ice, organs begin to deteriorate about three to four hours after retrieval. On the other hand, the Paragonix SherpaPak Cardiac Transport System can offer uniform cooling by suspending the donor heart in a preservation solution, and provides continuous temperatur ...
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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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Organ Transplant
Organ transplantation is a medical procedure in which an organ (anatomy), organ is removed from one body and placed in the body of a recipient, to replace a damaged or missing organ. The donor and recipient may be at the same location, or organs may be transported from a Organ donation, donor site to another location. Organ (anatomy), Organs and/or Tissue (biology), tissues that are transplanted within the same person's body are called autografts. Transplants that are recently performed between two subjects of the same species are called allografts. Allografts can either be from a living or cadaveric source. Organs that have been successfully transplanted include the Heart transplantation, heart, Kidney transplantation, kidneys, Liver transplantation, liver, Lung transplantation, lungs, Pancreas transplantation, pancreas, Intestinal transplant, intestine, Thymus transplantation, thymus and uterus transplantation, uterus. Tissues include Bone grafting, bones, tendons (both refe ...
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Medical Devices
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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