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Guidelines for storage of blood and plasma

28 May 2024
Regulations, methods and devices to ensure safety and efficacy of blood storage

The storage of blood and plasma, their planned and optimal use, it is a fundamental practice in modern medicine, essential to ensure safe transfusions and avoid unnecessary waste of a precious resource. Inadequate storage can lead to bacterial proliferation, degradation of blood cells and loss of plasma function, putting patient safety at risk. International and European regulations provide precise guidelines to ensure the quality and safety of stored blood. These regulations include guidelines for blood storage methods and requirements for storage and refrigeration equipment and facilities.

Types of blood storage

Storage of blood and blood components is essential to ensure that every unit collected is available and safe for use in patients in need. Different methods are used depending on the blood component to be stored and the specific medical need.

 

Storage of whole blood

Whole blood is rarely stored long-term because it is more efficient to separate blood into its main components: red blood cells, platelets and plasma. However, there are circumstances when whole blood is needed: such as in emergency situations requiring large quantities of transfusions, when rapid restoration of blood volume and cellular components is required.

 

  • Whole blood storage temperatures

    Whole blood should be stored between +2°C and +6°C. This temperature range is critical to prevent bacterial growth and to maintain the integrity of blood cells. According to the American Association of Blood Banks (AABB) and Food and Drug Administration (FDA) guidelines, storage at these temperatures can last up to 35 days when preservative solutions such as CPDA-1 (citrate phosphate dextrose adenine) are used.

 

Storage of blood components

Separation of blood components allows more efficient and targeted management of resources, improves the effectiveness of transfusions and reduces the risk of adverse reactions. The main components are: red blood cells (erythrocytes), platelets (thrombocytes) and plasma.

 

  • Red blood cells

    Red blood cells are stored in special refrigerators at a temperature between +2°C and +6°C. This preservation is necessary to maintain the ability of red blood cells to carry oxygen. By using preservative solutions such as SAGM (Saline Adenine Glucose Mannitol), red cells can be stored for up to 42 days. In special situations, red cells can be frozen at temperatures below -65°C using cryoprotectants such as glycerol, allowing storage for up to 10 years.

     

  • Platelets

    Platelets must be stored at a controlled room temperature (+20°C to +24°C) with continuous agitation to prevent aggregation. This is essential to maintain the functionality of platelets for clotting. Platelets can be stored for up to 5-7 days according to AABB guidelines.

     

  • Plasma

    Plasma is rapidly frozen at temperatures below -30°C to preserve clotting factors and plasma proteins. Plasma freshly frozen (PFC) must be frozen within 8 hours of collection to ensure quality. This method of preservation allows plasma to be used for up to 12 months in accordance with European Medicines Agency (EMA) and FDA guidelines.

 

Standards and requirements for blood storage equipment

The use of certified medical devices is mandatory for the storage of blood and blood components to ensure maximum safety and quality. According to Regulation (EU) 2017/745, in line with the previous Directive 93/42/EEC, blood storage medical devices must meet safety and performance requirements, including: precise temperature control (between +2°C and +6°C for red cells, < -30°C for plasma), alarm systems for deviations, continuous monitoring, back-up systems and CE certification for compliance with EU standards.

 

  • Blood bank refrigerators

    Blood bank refrigerators are designed to maintain stable and accurate temperatures, which are essential for the storage of blood and blood components. They must be equipped with alarm systems to signal temperature variations and ensure continuous monitoring of internal conditions to prevent any compromise to blood quality and safety.

     

  • Plasma Freezers

    Plasma freezers maintain plasma at very low temperatures, typically below -30°C. They must ensure that the required temperatures are maintained continuously and reliably. The quality of the plasma must be maintained over long storage periods and the equipment must be equipped with alarms and back-up systems to prevent failures that could compromise storage.

 

For maximum safety and quality in the storage of blood and blood components, rely on Evermed's certified equipment. Classified as Class IIa medical devices according to MDD 93/42/EC and registered with the Ministry of Health, our blood banks and medical freezers offer reliable solutions that comply with European regulations.

 

Contact us now to learn more about our products and improve your blood storage management!

 

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