Abstract
ObjectiveTo evaluate the in vivo and in vitro performance of a China-made dialysis machine (SWS-4000).MethodsThis was a multi-center prospective controlled study consisting of both long-term in vitro evaluations and cross-over in vivo tests in 132 patients. The China-made SWS-4000 dialysis machine was compared with a German-made dialysis machine (Fresenius 4008) with regard to Kt/V values, URR values, and dialysis-related adverse reactions in patients on maintenance hemodialysis, as well as the ultrafiltration rate, the concentration of electrolytes in the proportioned dialysate, the rate of heparin injection, the flow rate of the blood pump, and the rate of malfunction.ResultsThe Kt/V and URR values at the 1st and 4th weeks of dialysis as well as the incidence of adverse effects did not differ between the two groups in cross-over in vivo tests (P > 0.05). There were no significant differences between the two groups in the error values of the ultrafiltration rate, the rate of heparin injection or the concentrations of electrolytes in the proportioned dialysate at different time points under different parameter settings. At weeks 2 and 24, with the flow rate of the blood pump set at 300 mL/min, the actual error of the SWS-4000 dialysis machine was significantly higher than that of the Fresenius 4008 dialysis machine (P < 0.05), but there was no significant difference at other time points or under other settings (P > 0.05). The malfunction rate was higher in the SWS-4000 group than in the Fresenius 4008 group (P < 0.05).ConclusionsThe in vivo performance of the SWS-4000 dialysis machine is roughly comparable to that of the Fresenius 4008 dialysis machine; however, the malfunction rate of the former is higher than that of the latter in in vitro tests. The stability and long-term accuracy of the SWS-4000 dialysis machine remain to be improved.
Highlights
The incidence of end-stage renal disease (ESRD) has risen over the past several decades globally [1]
Since hemodialysis equipment accounts for the largest proportion of expense of hemodialysis treatment, domestication of hemodialysis equipment is a key step to lower the cost of hemodialysis
By referring to the China’s national standard “Requirements for the Safety of Hemodialysis, Hemodiafiltration and Hemofiltration Device” [9, 10], we performed this large-scale multi-center prospective controlled study to evaluate the in vivo and in vitro performance, stability, and durability of SWS-4000 dialysis machine, with an aim to get a better understanding of the quality of domestic hemodialysis machines to facilitate their wide use and help find what should be improved for them. Study design This was a multi-center prospective controlled study conducted in eight centers, with both in vivo and in vitro studies performed to compare the in vivo and in vitro performance of SWS-4000 dialysis machines made by Chongqing Shanwaishan Technology Co., Ltd (Chongqing, China) and Fresenius 4008 dialysis machines made by a German company (Fresenius, Germany)
Summary
The incidence of end-stage renal disease (ESRD) has risen over the past several decades globally [1]. Hemodialysis has become the standard treatment for ESRD and saved many patients’ life. Statistics from the Chinese National Renal Data System (CNRDS) show that more than 300,000 uremic patients are currently receiving hemodialysis treatment. Wang et al BioMed Eng OnLine (2017) 16:96 and the number of patients in need of hemodialysis may be as high as one to two million in the near future [2]. Most patients in China cannot afford regular hemodialysis treatment due to its high cost. Since hemodialysis equipment accounts for the largest proportion of expense of hemodialysis treatment, domestication of hemodialysis equipment is a key step to lower the cost of hemodialysis
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