[Point of care coagulation diagnostics-Absolutely necessary or only a reasonable supplement?]

Abstract

Point of care (POC) coagulation diagnostics have become an integral part of clinical patient care. In particular, the strengths of POC viscoelastometry (VET) lie not only in the rapid availability of test results but also in the fact that VET provides insights into coagulation that cannot be detected by standard laboratory tests. The relevance of POC-VET in the optimal management of patients with acutely acquired bleeding disorders, such as trauma-induced coagulopathy, is now unquestioned and is also reflected in the corresponding guidelines; however, VET also provides important information about fibrinolysis and fibrinolytic activity and in combination with other laboratory values can possibly also be sensitive for prothrombotic coagulation disorders. Therefore, POC-VET is increasingly being used in intensive care medicine. The use of POC diagnostics is not subject to the same standards as central laboratory testing. In order to maintain high quality and avoid harming patients, the requirements for medical device manufacturers in particular have been increased as part of the in vitro diagnostic reagents (IVDR) regulations, which places high demands on quality management in particular. The variety of POC devices and the lack of comparability between them remains an unsolved problem. It should be critically discussed to what extent medical device manufacturers and pharmaceutical companies could be legally required to keep unique and urgently needed technologies on the market, especially if no comparable alternatives will be available in the foreseeable future. Overall, from today's perspective, the use of POC coagulation diagnostics is essential for optimal patient care.