scope:

This Technical Information Report (TIR) addresses common aspects that pertain to the development and safe use of sorbent-based regenerative hemodialysis, hemodiafiltration, and hemofiltration systems. This TIR also provides a review of existing hemodialysis standards within the context of sorbent-based regenerative hemodialysis systems.

General

Sorbent-based regenerative hemodialysis systems prepare dialysis fluid by a regenerative process that removes unwanted substances from spent dialysis fluid and replaces desired substances to produce a regenerated fresh dialysis fluid to continue a hemodialysis treatment. Such systems may prepare the starting dialysis fluid from source water and electrolytes or may start from pre-manufactured dialysis fluid.

Inclusion This TIR addresses hemodialysis systems that regenerate dialysis fluid by exposing the dialysis fluid to materials that act by means of adsorption, catalysis, filtration, and exchange and infusing desired substances. Unless otherwise noted, references in this document to sorbent-based regenerative hemodialysis include sorbent-based hemodiafiltration and sorbent-based hemofiltration.

Exclusion

This TIR does not include:

• Peritoneal Dialysis Systems

• Single Pass Hemodialysis Systems

• Batch Hemodialysis Systems

• Non Sorbent-Based Dialysis fluid Regeneration Systems