Saturday, May 22, 2010

Hemostat Companies Persist With Animal Derived Production Despite Risks

Despite the World Health Organisation (WHO) recommending....."The pharmaceutical industry should ideally avoid the use of bovine materials and materials from other animal species in which TSEs naturally occur. If their use is absolutely necessary, bovine materials should be obtained from countries which have a surveillance system for BSE in place and which report either zero or only sporadic cases of BSE. These precautions apply to the manufacture of cosmetics as well."
Some Medical Device companies are seeming to blithely plunge onward commercialising animal derived hemostatic products. There does seem adequate reason for concern for this along with other technologies from safer sources.

Interested in Human-Horse Diseases? ClickHERE and HERE

Researchers have found new evidence for the existence of a subclinical form of bovine spongiform encephalopathy (BSE). Cattle, sheep, and other animals that are outwardly healthy may be harbouring the infection, with the risk that BSE could still be getting into the food chain.
In a new study based on a mouse model, researchers at the Medical Research Council Prion Unit took a closer look at the species barrier, which limits the ability of prions to jump from one species to another (Proceedings of the National Academy of Sciences 2000;97:10248-53).
In the study, scientists tried to infect laboratory mice with hamster prions and saw no apparent signs of disease. But when they looked more closely they found that the mice had high levels of prion in their brains.
"Previously scientists have injected mice with the hamster disease, found no clinical signs of infection, and concluded it cannot jump the species barrier," said Dr Andrew Hill of the University of Melbourne, one of the authors of the study.
The team, led by Professor John Collinge, director of the MRC Prion Unit, also found that the new subinfection could be easily passed on when injected into healthy mice and hamsters.
"These results have a number of important implications. They suggest that we should rethink how we measure species barriers in the laboratory and that we should not assume that just because one species appears resistant to a strain of prions they have been exposed to, that they do not silently carry the infection," said Professor Collinge.
He continued: "These new findings have important implications for those researching prion disease, those responsible for preventing infected material getting into the food chain, and those considering how best to safeguard health and reduce the risk that, theoretically, prion disease could be contracted through medical and surgical procedures."

Countries or regions with a controlled BSE risk
EU Member States — Belgium, Bulgaria, the Czech Republic, Denmark, Germany, Estonia, Ireland, Greece, Spain, France, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, the Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, the United Kingdom
EFTA countries — Switzerland, Liechtenstein
Third countries— Brazil, Canada, Chile, Taiwan, Mexico, United States

Tachosil - IFU and FDA info

Horse tendons for production of Collagen Sponge are collected from slaughterhouses. ---(b)(4)-- (horse–(b)(4)) slaughterhouses are certified by authorities of the European Union. -----(b)(4)---- slaughterhouses possess an approval of the EU veterinary authorities and are listed on the FSIS (USDA) list as certified facilities. All slaughterhouses are regularly inspected and approved by the national veterinary authorities and are audited by Nycomed. Each batch of horse tendons supplied to Nycomed is accompanied by a veterinary certificate and by a QA certificate issued by a quality responsible person at the slaughterhouse.
Transmissible Spongiform Encephalopathy
TachoSil has an acceptable safety profile with regard to prions. TachoSil does not contain any bovine ingredients. According to current knowledge, horses do not develop prion disease. Measures to avoid cross contamination of the equine tendons are in place at the slaughterhouses. For the Active Substances - Human Fibrinogen and Human Thrombin - strict plasma donor selection criteria are employed by the manufacturer.........Full FDA document with IFU available below.....