Cell salvage : Scientific evidence, clinical practice and legal framework

Abstract

Cell salvage is an efficient method to reduce the transfusion of homologous banked blood, as documented by several meta-analyses detected in a systematic literature search. Cell salvage is widely used in orthopedics, trauma surgery, cardiovascular and abdominal transplantation surgery. The retransfusion of unwashed shed blood from wounds or drainage is not permitted according to German regulations. Following irradiation of wound blood, salvaged blood can also be used in tumor surgery. Cell salvage makes avaluable contribution to providing sufficient compatible blood for transfusions in cases of massive blood loss. Certain surgical procedures for Jehovah's Witnesses are only possible with the use of cell salvage. Another possible use is the washing of homologous banked blood, e. g. to prevent potassium-induced arrhythmia or sequestration of autologous platelets. Other advantages besides agood compatibility are the high vitality and functionality of the unstored autologous red blood cells. These have been declared apharmaceutical product by the German transfusion task force in 2014, so that the autologous red blood cells are now under the control of the Pharmaceutical Products Act (AMG). The new hemotherapy guidelines, however, tolerate cell salvage only under strict rules, whereby the production of autologous blood during or after surgery is still possible without additional special permits. The new guidelines now require the introduction of aquality management system for cell salvage and regular quality controls. These quality controls include acontrol of the product hematocrit for every application, monthly controls of the protein and albumin elimination rates and the erythrocyte recovery rate for each cell salvage device. Testing for infection markers is not required. The application of cell salvage has to be reported to the appropriate authorities.