Wednesday, October 21, 2009

is blood transfusion is biologics or not?

Biologics are drugs generated from proteins and peptides (i.e insulin for diabetics).
Blood transfusions are considered a tissue transplant and NOT a biologic.In fact while biologics require FDA approval for use in patients, I don not believe the FDA has any regulatory overisght over blood (or other transplanated tissues).
From the earliest recorded, Blood has been a point of fascination and mystery. Early in time we see Blood represented as a source of passion in humans. We often hear "hot Blooded," "cold Blooded" and "bad Blood." As history records, Bloodletting was a common medical practice until the early 1800's. This combination of superstition and desire to do something meaningful for sick people, no doubt led to many deaths and the spread of disease. "Thinning the Blood," was also very popular, fruitlessly useless, and sometimes deadly. Early on, 'Blood transfusion' meant direct donor-to-patient transfusion. This practice, however, was frequently disastrous because there was no quality knowledge of Blood types, and compatibility. At first, even animal- to- human transfusion was tried. The practice of drawing and storing human Blood is a comparatively new science. Borne in these beginnings of human Blood transfusion, the need for storage of the rapidly perishable Blood became obvious. Early in 1932, the first facility, fully functioning as what would come to be known as a "Blood bank," was established in a Leningrad Russia hospital. Blood banking began growing rapidly with the return from World War II of physicians who had seen the effectiveness of transfusion therapy and began to demand that Blood be made available for treatment of their patients. Today, licensed Blood donation and banking establishments include centers that collect, process, store and distribute Blood and Blood products. These facilities are engaged in Interstate Commerce, and are therefore regulated under federal law. Standardization, inspection and enforcement are bringing the science of Blood banking to an ever newer, more useful and trusted place. Blood Transfusion, What is it?
Blood transfusion is the process of transferring blood or a blood component from one person, the donor, to another person, the recipient.How is this procedure performed?All donated blood is classified by type, either A, B, AB, or O, and as RH-positive or RH-negative. To protect the recipient, the blood is matched to his or her blood type. Before starting the transfusion, the healthcare professional cross-matches the donor blood by mixing a drop of it with the recipient's to make sure they are compatible. The healthcare professional will also double-check that the blood is intended for the recipient. Then, the donor blood is given slowly, through an intravenous (IV) line directly into the veins. Blood transfusions are given in units, with one standard unit of blood equaling about one pint. During the transfusion, medical personnel watch the patient closely for any adverse reactions. When the transfusion is complete, a compress bandage is placed over the area where the needle had been inserted.

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