Inactivation of TSE agents: safety of blood and blood-derived products.

Evidence relating to whether the blood of individuals with sporadic Creutzfeldt-Jakob disease is infectious is discussed. The conclusion is that this is unproven. Similar consideration is given to the blood of individuals with variant Creutzfeldt-Jakob disease; it is concluded that there is no convincing evidence that the blood is infectious but reasons for caution are presented. There is discussion regarding factors that add to the safety of plasma-derived therapeutic products, including the capacity of the manufacturing processes to inactivate or remove infectivity by the chemical and physical processes involved. There is extended discussion regarding the inactivation of these types of agents and the few reliable options available in worst-case scenarios such as the processing of instruments used neurosurgically on known or suspected cases. The most effective method is exposure to 1 M sodium hydroxide during autoclaving at 121 degrees C. The inappropriateness of applying any of the most effective methods to blood and blood-products because they are harsh and denaturing is discussed. Nevertheless, such procedures have potential application to the plant used in the manufacture of plasma-products. Evidence is presented which suggests that even more modest treatments (the use of lower concentrations of sodium hydroxide at lower temperatures) are effective when applied to surfaces that are free from any tissue contamination, as is the case with plant used to manufacture plasma-derived products. This evidence has come from studies carried out by the gelatin manufacturers of Europe regarding the capability of their manufacturing systems to inactivate the causal agent of bovine spongiform encephalopathy.