As a new bio-med technician in the dialysis industry, you will soon learn the importance of the Association for the Advancement of Medical Instrumentation, a nonprofit organization founded in 1967 and made up of nearly 7,000 technology professionals who support the health care community by developing, managing, and using safe and effective medical technology.
AAMI (www.aami.org) serves as a primary resource for the industry, the professions, and government for national and international standards. Created by its various committees, these standards help those managing dialysis clinics to control costs, and keep the renal team informed of new technology and policy developments.
AAMI and dialysis
AAMI serves an essential role in assuring safe and effective dialysis. The Renal Disease and Detoxification Committee is a dedicated multidisciplinary team of experts who develop voluntary standards for highly complex equipment, dialysis fluid, and dialysis water. They are published as American National Standards, and the renal community uses them in a variety of ways. Some are recognized by the Food and Drug Administration and some are referenced by the Centers for Medicare & Medicaid Services. Recently, AAMI adopted International Organization for Standardization standards, many of which were based on AAMI standards.
The Renal Disease and Detoxification Committee is working on a new AAMI Technical Information Report (TIR) on water testing methodologies; a possible new TIR on quality control for manufacturers, physicians, laboratories, and users; and a possible recommended practice standard on safe use of medical products in dialysis treatment.
In 2008, CMS adopted the ANSI/AAMI RD52 2004 standard Dialysate for hemodialysis as part of their regulations for the condition for coverage for dialysis clinics.This standard has subsequently been revised/replaced by the more current standards, ISO 11663 (2009), Quality of dialysis fluid for hemodialysis and related therapies, and ISO 23500 (2011), Guidance for the preparation and quality management of fluids for hemodialysis and related therapies. The significance of these newer standards is that they not only set higher quality requirements for final dialysate but also specify the quality requirements for ultrapure dialysate, and for online prepared substitution fluid. These are critical components for the development of the newer conventive renal therapies such as hemodiafiltration.
The AAMI Renal Disease and Detoxification Committee is always looking for more user input and new technicians are welcome to contact Cliff Bernier, director of standards at AAMI, at email@example.com or at 703.253.8263 to learn how they can join the committee.