Basic prerequisites for on‐line, high‐volume hemodiafiltration

High‐volume hemodiafiltration involves filtration of >23 L/treatment and its replacement by sterile non‐pyrogenic substitution fluid, while maintaining the patient's fluid balance. That volume of substitution fluid precludes the use of prepackaged sterile fluid. Instead, substitution fluid must be prepared on‐line using machines that incorporate a series of bacteria‐ and endotoxin‐retentive filters. The sterilizing ultrafilters are validated to deliver sterile, non‐pyrogenic fluid to the patient when operated according to the machine manufacturer's instructions and in compliance with international standards and regulatory oversight. A successful hemodiafiltration program also places important responsibilities on the user. Specifically, the user is responsible for ensuring that the dialysis water or dialysis fluid delivered to the sterilizing filters of the hemodiafiltration machine meets the machine manufacturer's specifications and is consistent with the quality used in the sterilization validation process. The user is also responsible for ensuring that the treatment prescription allows a filtration volume >23 L/treatment to be achieved by careful selection of a dialyzer, blood flow rate and treatment time. Questions related to assurance that the substitution fluid will routinely be sterile and non‐pyrogenic have limited the uptake of on‐line hemodiafiltration as a therapeutic option in some countries, such as the United States.