Quality Management in Blood Salvage: Implementation of Quality Assurance and Variables Affecting Product Quality

Abstract

Implementation of quality management in intraoperative blood salvage with controls of product and process quality supports early recognition and repair of dysfunction if respective actions are laid down in the quality management handbook. In order to avoid insufficient quality and to improve process quality, a broad understanding of the processes and of the variables affecting quality is needed, which is based on experimental tests. For this purpose the use of fresh whole blood as test blood and of protein as parameter for determination of the plasma elimination rate is favorable over outdated banked blood and free hemoglobin. Tested this way, the process of blood collection by suction is by far not as harmful to RBCs as expected. Partially filled bowls, lower wash volumes, or a fastened filling or washing should be avoided. Plasma washout can be improved by higher wash volumes or by slower filling and washing, which avoids increased loss of RBCs. Quality management which is based on a better understanding of the procedure as well as quality controls can help to supply high-quality blood for optimal hemotherapy by blood salvage.

Processing of small volumes in blood salvage devices

“…19 Processing partially filled bowls is a possible option to increase RBC recovery but not recommended because of decreased elimination rates. 23,24 Data of this study suggest that in children washout rates were only minimally reduced from 99.5% to 99.0% due to a lower Hct and a slower filling of the 55-mL bowl. Therefore, the use of partially filled bowls in infants can be considered undesired, but under certain circumstances even recommended.…”

“…If the TB volume did not match the bowl volume, wound blood was only partly processed by ELECTA and RBC recovery rates were falsely calculated low . Processing partially filled bowls is a possible option to increase RBC recovery but not recommended because of decreased elimination rates . Data of this study suggest that in children washout rates were only minimally reduced from 99.5% to 99.0% due to a lower Hct and a slower filling of the 55‐mL bowl.…”

Lactate dehydrogenase and Haemolysis Index as quality control markers of haemolysis in intra‐operative cell salvage

“…Within ICS this can be caused by the surgical procedure as well as occurring at the collection (aspiration method, vacuum pressures for example) or processing stages. It has been suggested that haemolysis levels may increase during machine use (Hansen et al, 2004).…”

A new approach for fat removal in a discontinuous autotransfusion device–concept and evaluation

“…In general, in the ‘total amount approach’, all input and all output, including several cycles and the final emptying, are considered. In the ‘per cycle approach’ that is more feasible for clinical quality controls, only the blood input and the product of one cycle (one bowl filling and automatic processing) are considered .…”