Blood and Blood Components

Human blood and blood components are used in a vast range of essential and life-saving treatments. For example, in surgery, treating cancer and inherited blood diseases.

A high level of control is needed when collecting, testing, processing, storing, and distributing human blood and blood components to ensure the quality and safety of the blood and their components. This is to protect human health and prevent the transmission of diseases.

Legislation

The requirements to ensure the quality and safety of blood and its components are set out in in S.I. No. 360 of 2005 (Quality and Safety of Human Blood and Blood Components) Regulations.

These regulations apply to blood establishments and hospital blood banks.

A blood establishment is any structure or body involved in any aspect of the collection, testing, processing, storage and distribution of blood and blood components.

A hospital blood bank is a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities.

How do we regulate?

We are the Competent Authority responsible for the regulation of blood in Ireland.

We are responsible for:

• Ensuring legislation is implemented.
• Licensing and inspecting blood establishments.
• Working with the National Haemovigilance Office, particularly for serious adverse reactions and events.