AAMI News March 2020

Standards Spotlight: AAMI Adopts Updated and Redesignated Series of Dialysis Standards

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ANSI/AAMI/ISO 23500-1:2019, Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements

ANSI/AAMI/ISO 23500-2:2019, Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies

ANSI/AAMI/ISO 23500-3:2019, Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies

ANSI/AAMI/ISO 23500-4:2019, Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies

ANSI/AAMI/ISO 23500-5:2019, Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies

 

The International Organization for Standardization (ISO) has released a redesignated and revised series of five standards that provide healthcare professionals, manufacturers, and other specialists with guidance for ensuring the quality and safety of dialysis fluids for hemodialysis and related therapies.

This new series, ANSI/AAMI/ISO 23500, Preparation and quality management of fluids for haemodialysis and related therapies (parts one through five), was approved by AAMI and the American National Standards Institute (ANSI), and emphasizes the interrelated nature of the dialysis fluid requirements.

“Making the related standards a series should help healthcare professionals, manufacturers, designers, and suppliers to the hemodialysis community navigate important information and requirements for dialysis water, dialysis fluid, and their preparation,” said Jo-Ann B. Maltais, cochair of the AAMI Renal Disease and Detoxification Committee and expert member of the ISO committee that redesignated the standard, ISO/TC 150/SC 2/WG 5.

Sterilization professionals will be particularly interested in ANSI/AAMI/ISO 23500-2:2019 because it covers devices used to treat potable water intended for use in the delivery of hemodialysis and related therapies as well as the reprocessing of dialyzers intended for single use where permitted for multiple uses and the reprocessing of dialyzers not specifically marked as intended for single use.

To create the series, the ISO committee consolidated topics and limited references to a single source in order to increase message consistency across the five standards. Several technical revisions were also incorporated that focus on risk management, prevention, and remediation to improve patient outcomes, including:

  • Microbiology testing methods. Previously a U.S. deviation from the International Standard, the Tryptic Soy Agar method for detecting bacteria in dialysis water and standard dialysis fluid, is now included.
  • Sampling methods and their application. The base standard now includes three acceptable options for dialysis fluid sample collection: the manufacturer’s instructed method, the standard guidance if no instructions are provided, and a facility-validated method.
  • Storage and handling of testing samples. The 23500 series provides additional guidance for dialysis water and dialysis fluid sample storage.
  • Home hemodialysis. The ISO committee added information about backflow prevention, electrical safety, and personnel for home hemodialysis systems.

The ANSI/AAMI/ISO 23500 series of standards are now available for purchase through the AAMI Store.