Performance of a new‐generation continuous autotransfusion device including fat removal and consequences for quality controls

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Autotransfusion is essential to reduce the need for allogenic blood. Allogenic blood transfusions are associated with multiple risks including infection and immune modulation (Waters, 2013). Alongside discontinuous bowl‐based systems, a continuous autotransfusion device was introduced into the market in 1995 (Dai et al., 2004). This continuous autotransfusion system (C.A.T.S.), is widely used in clinical settings, with some special features like high‐product haematocrit and fat removal (Burman et al., 2002; Yoon et al., 2014; Seyfried et al., 2015). Recently, a new‐generation continuous autotransfusion device CATSmart has been introduced into the market. In order to provide a safe red blood cell (RBC) product and to meet high‐quality standards, the implementation of a quality management system is necessary (Hansen and Altmeppen, 2002; Kelleher et al., 2011). Accordingly, the performance of this new device has to be evaluated. RBC recovery and the elimination of plasma and unfavourable contaminants are the main quality parameters reviewed (Hansen and Altmeppen, 2002). Currently, fat elimination and heparin removal have received additional attention in cell salvage, and especially high fat elimination has been reported for C.A.T.S (Seyfried et al., 2015).
For evaluation of these quality parameters, samples are taken from the starting material and from the produced RBC. Comparing only concentrations is misleading as the process includes both cell separation (without a change in concentration) and washing (which includes dilution), and amounts of input and output have to be considered instead. For experimental tests, a comparison of total input to total output is a reasonable approach, whereas in clinical practice, withholding high blood volumes from the patient is not acceptable, and results regarding product quality should be accessible at an early stage of blood processing (Hansen & Altmeppen, 2002). Therefore, analysis of a portion is requested for clinical quality controls. For discontinuous autotransfusion devices, the portion is defined as the processing of a single bowl. In contrast, no defined portions exist for continuous autotransfusion devices as filling, washing and emptying are performed simultaneously (Dai et al., 2004). The results for quality control depend on sample size and time of sampling (Hansen & Altmeppen, 2002), but no clear recommendations have been proposed for continuous autotransfusion devices to date. To address this issue, samples are taken during blood processing and after the ‘emptying for final product’ step in this study. The aim of this study was to characterise performance of a new‐generation continuous autotransfusion device with regards to plasma and fat elimination, RBC recovery and product hematocrit (Hct). Furthermore, testing of two different approaches should result in new insights about quality control in continuous autotransfusion devices.
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