Quality management of dialysis fluid for online convective therapies

Increasing evidence supports use of convective therapies, such as hemodiafiltration, to improve outcomes for hemodialysis patients. Maximizing convection requires large volumes of substitution solution, which is practical only if online technology is used for its preparation. Substitution solution must be sterile and non-pyrogenic. Since it is not practical to test solutions prepared online for sterility and non-pyrogenicity before use, they must be prepared using processes that have been validated to produce solutions of the required quality. Preparation of substitution solution begins with treatment of municipal water to produce dialysis water, followed by proportioning of that water with concentrates to provide dialysis fluid, and ends with sequential filtration of the dialysis fluid with bacteria- and endotoxin-retentive filters to provide substitution solution. Whether dialysis fluid is prepared centrally or using individual dialysis machines, production of sterile, non-pyrogenic substitution solution requires maintenance of a hygienic chain from the beginning to the end of the fluid-handling pathway. Maintaining the integrity of that hygienic chain under routine operating conditions requires a comprehensive quality management program involving the design, operation and maintenance of all fluid-handling systems and ongoing training of the staff responsible for all aspects of their use.