AAMI Adopts Updated Series of Dialysis Standards

The International Organization for Standardization (ISO) has released a redesignated and revised series of five standards that provide healthcare professionals and manufacturers 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) emphasizes the interrelated nature of the dialysis fluid requirements and was recently adopted by AAMI and the American National Standards Institute.

The base standard for the series, ANSI/AAMI/ISO 23500-1, provides healthcare professionals with guidance on the preparation of dialysis fluid for hemodialysis and related therapies and substitution fluid for use in online therapies, such as hemodiafiltration and hemofiltration. The other four are meant for use by manufacturers/suppliers and in some cases the end user.

“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.

To create the series, ISO committee members 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 (TSA) 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.

AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of more than 10,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.