Patient information

If you or someone you care for needs blood or blood products, finding clear, credible information can be hard. This page provides information, resources and links to trustworthy sources that may assist you.

If you have questions about anything on this page, please contact us.

Blood product safety

Australia has several standards and requirements to ensure blood product safety, quality and efficacy. These include:

• licensing manufacturers
• performing pre-market assessments
• testing products
• auditing manufacturers.
   

Regulating blood products

Blood product manufacturers must meet stringent guidelines for producing safe blood products. This applies to both Australian suppliers and those from overseas.

The Therapeutic Goods Administration (TGA) is the Australian Government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. This includes medicines, medical devices and biologicals.

The TGA is also responsible for regulating blood products and establishing production standards. This includes:

• auditing licensed manufacturers to ensure they comply with good manufacturing practice
• issuing directives such as donor deferrals
   
• issuing licences to companies that manufacture blood or blood products
• making changes to safety standards
• managing product recalls
• regulating the sector to ensure effective, safe, high-quality blood and blood products under the Therapeutic Goods Act 1989 (Cth)(Opens in a new tab/window)
• reviewing and approving the Guidelines for the Selection of Blood Donors.

The TGA website provides more information about the regulation of blood(Opens in a new tab/window).

Reporting adverse events

The TGA also tracks adverse events (unintended and sometimes harmful occurrences) related to therapeutic goods, including blood transfusions and blood products.

Learn more about reporting adverse events to the TGA(Opens in a new tab/window).

Find out more about transfusion-related adverse events.

Lifeblood

Lifeblood collects, stores and distributes fresh blood and blood products in Australia. This means it also has certain responsibilities in ensuring blood products are safe.

Learn more about Lifeblood(Opens in a new tab/window).

Selecting or deferring donors

A safe blood supply starts with carefully managing who can donate blood. This also helps to keep donors safe.

Lifeblood assesses whether people are eligible to donate by:

• requiring potential donors to fill out a form
• interviewing respondents about their answers
• performing a brief physical check.

Based on the selection guidelines, Lifeblood assesses each potential donor's eligibility(Opens in a new tab/window).

Testing blood

After collecting donated blood, Lifeblood is responsible for testing it for several infectious diseases(Opens in a new tab/window).

Regulated or mandated tests are:

• hepatitis B
• hepatitis C
• human immunodeficiency virus (HIV)
• human T-lymphotropic virus (HTLV) types I and II
• syphilis.

Tracking and tracing

Track-and-trace mechanisms are in place to ensure all donations can be tracked from their entry point to the recipient. Any imported blood products also need to be traceable through this system.

Product recall processes rely on these tracking and tracing mechanisms to ensure blood product safety and quality.

Lifeblood currently uses a sample archive process, which involves keeping a small sample from each blood donation. Testing this sample allows Lifeblood to quickly identify any blood supply risks and analyse any adverse events.

Bleeding disorders, blood disorders and other conditions

Transfusing blood or using blood products can be part of treating some health conditions.

We call these conditions 'blood disorders', and they include:

• anaemia – conditions in which your body does not have enough haemoglobin or red blood cells 
   
• bleeding disorders – conditions in which your blood either clots too much, or does not clot enough
• blood cancers – conditions in which certain cells in your blood become cancerous.

Bleeding disorders | Blood disorders

Some people also require blood or blood product transfusions for other reasons, including:

• major surgical procedures
• serious injuries
• childbirth blood loss
• kidney disease, which can result in anaemia
• chemotherapy side effects.

MyABDR and the Australian Bleeding Disorders Registry

The Australian Bleeding Disorders Registry (ABDR) is a database of Australians who have bleeding disorders. It's a clinical tool specialists use to plan for patient needs and improve treatment results.

MyABDR helps patients share information with their clinicians about home treatments and bleeds. The MyABDR app and website interface with our ABDR database.

MyABDR app | ABDR

Other information for patients and carers

These resources will help you to understand best practices for blood products. They provide useful information on how to rely less on donated blood products if you:

• plan to have surgery
• have an iron-deficiency anaemia diagnosis.

Blood transfusions

Before having a blood transfusion for the first time, it's helpful to know:

• the different types of transfusion
• the risks and benefits of a transfusion
• what to expect.

Lifeblood has useful patient information about blood transfusions(Opens in a new tab/window).

Other good sources to consult include:

• Information for consumers - Clinical Excellence Commission (nsw.gov.au)(Opens in a new tab/window) – the NSW Government Multicultural Health Communication Service provides patient information translated into many languages.
   
• Blood Matters(Opens in a new tab/window) – the Victorian Government in association with Lifeblood provides information about blood transfusions for adults and children.
• Blood transfusions(Opens in a new tab/window) – SA Health provides patient information translated into many languages.
• Blood Watch(Opens in a new tab/window) – the NSW Government's Clinical Excellence Commission supports safe blood management by identifying and addressing risks around blood transfusions and providing transfusion information for patients and carers.
   

Patient blood management

If your clinician recommends surgery as part of your treatment, they should discuss patient blood management principles with you.

Patient blood management improves patient outcomes by improving the patient’s medical and surgical management in ways that boost and conserve the patient’s own blood.

Learn more about patient blood management(Opens in a new tab/window).

Public consultations

We invite you to give us input when we plan, develop and test policies and guidelines.

Learn more about our open and recently closed consultations(Opens in a new tab/window).

Get in touch

If you have a query about blood or blood products, please contact us.