Assessing Hemocompatibility for Medical Devices in Contact with Circulating Blood

Many commonly used medical devices, such as catheters, cardiopulmonary bypass systems, and endovascular grafts, are intended to come in contact with circulating blood. Therefore, these devices require an assessment for hemocompatibility risks such as hemolysis and thrombosis prior to submitting to a regulatory agency for market approval. The testing required for the evaluation of these specific endpoints depends on the exposure type and duration of the specific medical device under focus, and the guidance is captured in Table 1 of ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood. The tests highlighted in the standard are used to evaluate the different aspects of hemocompatibility. For example, hemolysis determines the degree of red blood cell lysis and the release of hemoglobin caused by medical devices, materials, and their extracts in vitro. Other specific hemocompatibility tests can also be designed to simulate the geometry, contact conditions, and flow dynamics of the medical device or material during clinical applications and determine blood, material, and device interactions. For devices having direct contact with circulating blood (regardless of contact duration), the U.S. FDA recommends that hemolysis, complement activation, and thrombogenicity testing be considered, if not otherwise addressed during the risk assessment process. On the other hand, for devices having only indirect contact with circulating blo...
Source: MDDI - Category: Medical Devices Authors: Tags: Testing Source Type: news