Why is it important to know the hemolytic properties of a finished medical device and its components?
Because hemolytic properties are responsible for the hemolysis that may take place during the use of a medical device.
What is hemolysis?
It is the rupturing of red blood cells accompanied by the release of hemoglobin. Hemolysis can cause adverse effects in the patients’ health.
What is the clinical significance of hemolysis?
- Oxygen transport: a significant reduction in the amount of red blood cells compromises the capability of transporting oxygen, which may result in organ or tissue damage.
- Toxic effect: elevated levels of free plasmatic hemoglobin can induce toxicity or initiate processes capable of altering the kidney function, as well as other organs. The concentration of free plasmatic hemoglobin is a direct indicator of red blood cell damage, but also of other constitutive elements of blood.
- Thrombosis: extra-vascular hemolysis promotes the formation of thrombi.
Thrombi are composed by a combination of red blood cells, platelets, fibrin and other cellular elements in blood. They can obstruct blood flow in the places where they are formed, preventing oxygen supply and blood flow to surrounding tissue. This can cause damage, destruction (infarction) and even the death or necrosis of tissue in that area.
The Hemolysis Test is an evaluation of hemocompatibility, designed to determine the hemolytic properties of finished medical devices and its components.
At BioAplicada we carry out for our clients the In Vitro Hemolysis Test for medical devices or materials that come into direct or indirect contact with blood.
The test is performed following the guidelines of ISO 10993-4 regulation.