The ISO 1135 guidelines provide a comprehensive framework for the hemocompatibility analysis of transfusion equipment used in medical settings. These standards ensure that the equipment is safe and effective for blood transfusions, minimising the risk of adverse reactions in patients. ISO 1135-4 focuses on transfusion equipment that operates with gravity feed, while ISO 1135-5 addresses transfusion equipment used with pressure infusion apparatus.
When evaluating the hemocompatibility of transfusion equipment in accordance with ISO 1135-4 and ISO 1135-5, two critical assessment parameters are considered: depletion of blood components and damage to blood components.
Depletion of Blood Components
A primary concern during transfusion is the potential depletion of essential blood components. This parameter evaluates how the transfusion equipment impacts the levels of various blood components, such as red blood cells, platelets, and plasma proteins. The goal is to ensure that the equipment does not excessively deplete these components, which are vital for the patient’s health and recovery.
Damage to Blood Components
Another crucial aspect of hemocompatibility testing is assessing any potential damage to blood cells and other components caused by the transfusion equipment. This includes evaluating the mechanical stress and shear forces exerted on blood cells and on plasma proteins as they pass through the equipment. Damage to red blood cells, for instance, can lead to hemolysis, potentially causing serious complications. Similarly, damage to platelets and plasma proteins can impair their function, leading to issues with clotting.
The testing process should simulate real-world conditions to observe and measure any adverse effects on blood components. It is therefore recommended to select parameters such as VTBI (Volume to be Infused), flow rates, etc. that closely mimic clinical settings.