Friday, March 28, 2008

FDA moves to prevent Mad Cow Disease infecting Hemostat's and other Devices

The FDA is moving (some would say with glacier-like speed) to barr deadly prions from contaminating humans and animals via prohibiting the use of "high risk" animal products being used in drugs, biologics and medical devices (e.g. hemostat's) intended for humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:

the brain, skull, eyes and spinal cords from cattle 30 months and older;
the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
any material from "downer" cattle--those that cannot walk;
any material from cattle not inspected and passed for human consumption;
fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
mechanically separated beef.
FULL TRANSCRIPT HERE

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