Blood regulation and safety
Information about ensuring blood and blood component safety.
MHRA is responsible for the regulation of blood quality and safety. This applies to the regulation of:
- blood establishments
- hospital blood banks and facilities.
We achieve this by implementing the Blood Safety and Quality Regulations 2005 (as amended).
A blood establishment is authorised for the collection, testing, processing, storage and distribution of blood and blood components intended for transfusion. Blood establishments can also be authorised to collect and test blood intended for further manufacture of medicinal products.
A hospital blood bank is any unit in a hospital which stores and distributes, and performs compatibility tests on, blood and blood components, exclusively for use in hospital facilities, including hospital-based transfusion activities.
Blood and blood components collected under these regulations not intended for transfusion may be further processed into blood products.
You can report on the safety of medical devices and blood products through the Yellow Card system.
Ensuring blood safety
MHRA is the UK competent authority for blood and blood components when used for transfusions or further manufacture into a medicine. This includes use in private hospital settings, not just the NHS.
We are responsible for haemovigilance: a set of surveillance procedures covering the donation and processing of blood and its components through to their provision and transfusion to patients, and including their follow-up. This ensures that:
- blood components for transfusion meet applicable standards of safety, quality and efficacy
- the supply, distribution and use of blood components are safe
We are also responsible for some of the main ways in which blood aligns with other regulations (for example, medical devices and medicines).
We are not responsible for the clinical use of blood in NHS or private hospital settings.
We have powers to inspect blood donation centres and NHS and private blood banks, seeking assurance around quality and safety from donor selection to blood processing prior to clinical use in the NHS and private hospitals.
We inspect UK blood processing sites, testing sites, fixed blood collection sites and a representative selection of mobile collection sites as part of a routine inspection programme. We also supervise all hospital blood banks that receive blood components and inspect a representative number of those sites.
Within this framework, we work closely with other bodies to protect the safety of patients undergoing transfusion, including:
- SaBTO (Advisory Committee on the Safety of Blood, Tissues and Organs) an expert committee whose role is to provide high-quality advice and recommendations on the most appropriate ways to ensure the safety of blood, cells, tissues and organs for transfusion or transplantation (the committee is sponsored by the Department of Health and Social Care but provides its recommendations directly to ministers and health departments)
- Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee, whose role is to prepare detailed service guidelines for the UK Blood Transfusion Services (UK BTS) and to be an advisory committee to UK BTS