Treatment product safety is a high priority for Australian blood bank services, manufacturers, the National Blood Authority and regulatory bodies, such as the Therapeutic Goods Administration, and the bleeding disorders community.
Manufacture of blood products, such as plasma factor concentrates, is carefully regulated and monitored to make sure that blood products are now as safe as possible from infections that can be transmitted by blood, such as Human Immunodeficiency Virus (HIV), hepatitis B and C and variant Creutzfeldt-Jakob Disease (vCJD):
- In Australia blood donors are screened and blood donations are tested for HIV, hepatitis B and C, human T-cell lymphotropic virus (HTLV) and syphilis
- When they are manufactured, factor concentrates made from human plasma are treated with several processes to remove or inactivate HIV and viral hepatitis and, as far as possible, exclude other known infectious agents that are passed on by blood
- Most people in Australia are now treated with recombinant clotting factor or non-factor therapies. They are genetically engineered and contain little or no human or animal material. There have been no reports that viruses have been transmitted by recombinant or non-factor products.
In Australia during the mid-1980s some people with bleeding disorders acquired HIV from contaminated clotting factor concentrates made from human plasma. During the early 1990s many people with bleeding disorders also found that they had been exposed to hepatitis C through the clotting factor concentrates they used for their treatment.
The risk of new infections from using human blood products is now thought to be extremely low. However, it cannot be entirely excluded, particularly if the risk came from a new or unknown type of blood-borne virus or other micro-organisms causing disease. Because of this, people using these products and patient advocacy organisations such as HFA continue to take a strong and watchful interest in product safety.