Water Treatment and Safety Requirements

Abstract

On-line haemodiafiltration differs from other forms of haemodialysis in that up to 20 L/h of dialysis fluid can be infused directly into the bloodstream during each treatment. That infused fluid must be free of chemical contaminants, sterile and pyrogen-free. Compliance with that requirement cannot be demonstrated by testing at the time of infusion. Instead, the infused fluid must be prepared using equipment that has been validated to produce sterile and pyrogen-free fluid when operated in accordance with the machine manufacturer’s instructions. It is the responsibility of the user of the machine to ensure those instructions are followed, including providing the dialysis machine with water and concentrates that meet the specifications set forth by the machine manufacturer. Properly designed systems for water treatment and distribution and concentrate preparation are central to achieving that goal. In addition, those systems must be subject to rigorous quality control that includes maintenance practices designed to prevent contamination of the dialysis and infusion fluids, coupled to monitoring that verifies the adequacy of the system design and maintenance program.