Haemovigilance: A set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the use of labile blood products, and to prevent their occurrence or recurrence
Adverse event: An unintended and undesirable occurrence before, during or after transfusion of blood or blood components. Adverse events include both incidents and adverse reactions.
Adverse reaction: An undesirable response or effect in a patient temporally associated with the administration of blood or blood components. It may or may not be the result of an incident. Infection – very rare
- Examples:
- Transfusion-associated circulatory overload – one to watch for
- Transfusion-related acute lung injury – rare
- Allergic/febrile – the most common
- Haemolysis
Incident: Any error or accident that could affect the quality or efficacy of blood, blood components, or patient transfusions. It may or may not result in an adverse reaction in a transfusion recipient.
Near miss: A subset of incidents that are discovered before the start of a transfusion that could have led to a wrongful transfusion or an adverse reaction in a transfusion recipient.
Serious adverse event: any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity
Serious adverse reaction: an unintended response in donor or in patient associated with the collection or transfusion of blood and blood components that is fatal, life-threatening, disabling or incapacitating or which results in, or prolongs, hospitalization or morbidity.
- Example:
- Immediate and life-threatening : ABO-incompatibility; anaphylaxis
- Hours: pulmonary complications, bacterial infections, transfusion reactions
- Days: haemolytic reactions
- Late (months or years): viral infections; iron overload
Unexpected adverse drug reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics
Transfusion-transmitted infections (TTIs) are infections resulting from the introduction of a pathogen into a person through blood transfusion. A wide variety of organisms, including bacteria, viruses, prions, and parasites can be transmitted through blood transfusions.
- Examples of known TTIs include: hepatitis A, B, C, D and G, HIV, HTLV I and II, West Nile Virus, syphilis, cytomegalovirus, and malaria.
Acute transfusion reactions present as adverse signs or symptoms during or within 24 hours of a blood transfusion. The most frequent reactions are fever, chills, pruritus, or urticaria, which typically resolve promptly without specific treatment or complications.
For more definitions on Hemovigilance – Adverse Reactions please refer to below link:
https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf#page=8
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