Oversight and Protection Against Problems in Blood Banking
Blood Banking History
...
class | grid-col-6 |
---|
In 1934, the first human blood product licenses were issued to two pharmaceutical houses for human immune globulin prepared by ammonium sulfate precipitation. After the development of cold ethanol fractionation procedures, additional new products were licensed including normal human plasma (1940), normal serum albumin (1941), and immune serum globulin (1943). The first license for interstate shipment of whole blood, and the first blood bank license was issued to the Philadelphia Blood Bank in 1946. Each of these products was licensed under Section 351 of the Public Health Services Act and was considered analogous to therapeutic serum.
...
class | grid-col-6 |
---|
Span | ||
---|---|---|
| ||
Becton, Dickinson & Co. Yale Luer-Lok 100 cc Syringe from between 1953 and 1970. In 1934, BD introduced the BD Yale Luer-Lok™ Syringe, designed and patented by Fairleigh S. Dickinson, Sr. It provided a simple, secure method of attaching and removing a needle to and from a syringe. Today, Luer-Lok connectors are the standard for syringes in the United States. |
...
class | credit |
---|
...
Blood and Blood Products
...
class | grid-col-6 |
---|
Blood products can include blood, red blood cells, fresh/frozen plasma, platelets, plasma derivatives, albumen, immune globulins, clotting factor concentrates, things that are made by recombinant DNA technology, reagents that test for infectious disease or are used to type the blood, and even the blood bank software used to keep track of the donations. All of these were regulated by the NIH Division Biologics Standards (DBS) and later the Center for Biologics Evaluation and Research (CBER) when they were transferred to the Food and Drug Administration (FDA).
Dive | ||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||||||||||||||||||||||
|
...
Dive | ||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||||||||||||||||||||||||||
Span | credit | NIH Office of History & Stetten Museum In 1962, the DBS brought suit against John P. Calise and the Westchester Blood Bank for intentionally altering the expiration dates on whole blood so that the product dating would exceed the 21-day requirement. He pleaded guilty and was convicted in 1964 on three counts of misbranding, three counts of false labeling, two counts of shipping an unlicensed biological product, and one count of conspiracy. Calise was placed on probation for five years and forbidden to engage in the manufacture, distribution, or sale of any biological, plasma, or blood products. The case marked the first court confirmation that blood is a drug under the definition of the Food, Drug, and Cosmetic Act. The case also marked the first litigation brought against a biologics manufacturer. Blood banks and blood products were regulated through the NIH DBS Laboratory of Blood and Blood Products. When the DBS transitioned administratively from the NIH to the Food and Drug Administration (FDA), their regulatory role continued in the Division of Blood and Blood Products. Other court cases against blood banks soon followed:
|