Standard: AAMI RD52

DIALYSATE FOR HEMODIALYSIS

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Scope:

General

The intent of this recommended practice is to provide dialysis practitioners with guidance on the preparation of dialysate for hemodialysis and related therapies, from the point at which municipal water enters their dialysis facility to the point at which the final dialysate enters the dialyzer. Included in the scope of the recommended practice are: (1) use, maintenance, and monitoring of equipment used to purify and distribute water used for the preparation of dialysate and other hemodialysis applications; (2) use, maintenance, and monitoring of equipment used to prepare concentrate from powder at a dialysis facility; and (3) preparation of the final dialysate from purified water and concentrate. The equipment used in the various stages of dialysate preparation is generally obtained from specialized vendors. This recommended practice provides a general description of the system components that these vendors may provide. These descriptions are intended to provide the user with a basis for understanding why certain equipment may be required and how it should be configured; they are not intended as detailed design standards. Dialysis practitioners are generally responsible for maintaining the equipment used to prepare dialysate following its installation. Therefore, this recommended practice provides guidance on monitoring and maintenance of the equipment to ensure that dialysate quality is acceptable at all times. At various places throughout this recommended practice, the user is advised to follow the manufacturer's instructions regarding the operation and maintenance of equipment. In those instances in which the equipment is not obtained from a specialized vendor, it is the responsibility of the user to validate the performance of the equipment in the hemodialysis setting and to ensure that appropriate operating and maintenance manuals are available.

The guidance provided by this recommended practice should help protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminants that may be found in improperly prepared dialysate. However, the physician in charge of dialysis has the ultimate responsibility for ensuring that the dialysate is correctly formulated and meets the requirements of all applicable quality standards.

Inclusions

This recommended practice addresses the user's responsibility for the dialysate once equipment has been delivered and installed. For the purposes of this recommended practice, the dialysate includes water used for the preparation of dialysate, water used for the preparation of concentrates at the user's facility, and water used for the preparation of ultrapure dialysate, as well as the final dialysate and concentrates. Because it is commonly prepared and distributed using the same equipment as the water used to prepare dialysate, water used to reprocess dialyzers is also covered by this recommended practice. This recommended practice includes an annex containing recommendations for home hemodialysis.

Exclusions

Excluded from the scope of this recommended practice are sorbent-based dialysate regeneration systems that regenerate and recirculate small volumes of dialysate, systems for continuous renal replacement therapy that use prepackaged solutions, and systems and solutions for peritoneal dialysis.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami rd52
Publish Date: 2004-01-01
Page Count: 67
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive

This Standard References

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