REVISED: Preconfigured Hemodialysis Systems

• Preconfigured dialysis systems are designed to deliver water and dialysate quality that meet safety standards, simplifying dialysis treatment for both in-center and home use. Preconfigured hemodialysis systems differ from traditional hemodialysis water systems and therefore all the requirements of 42 CFR 494.40 Water and Dialysate Quality may not be applicable to the function of a preconfigured hemodialysis system.
• Consistent with 42 CFR 494.40(e) surveyors must evaluate water and dialysate quality for preconfigured hemodialysis machines by verifying that the Food and Drug Administration (FDA) and manufacturer’s labeling for the machine are followed by the facility.
• Facilities are expected to ensure dialysis machines and equipment are operated and maintained in accordance with the manufacturer’s directions for use and applicable FDA labeling for machine use and monitoring of the water and dialysate quality.

The initial guidance published in S&C-16-32 is being revised to expand its applicability to any pre-configured hemodialysis system that has received FDA clearance for home and in-center use.