AAMI Releases 4 Revised Dialysis Standards

November 2, 2007 // Published as a news service by IHS

The CD version includes guidance from the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC).

The collection includes these four updated standards:

• ANSI/AAMI RD62:2006 - Water treatment equipment for hemodialysis applications
  The RDDC revised its standard for water treatment equipment adding alternative and supplementary methods of removing toxic chloramines from water.

  "Chloramines are highly toxic to hemodialysis patients and need to be adequately removed by the water treatment system," said Richard Ward, PhD, chair of the RDDC and professor of medicine in the University of Louisville’s Kidney Disease Program.

  "We have included technologies in the standard that may be used to replace or supplement the conventional approach to removing chloramines."

  The standards scope includes water used for the preparation of concentrates from powder at a dialysis facility, the preparation of dialysate and the reprocessing of dialyzers for multiple uses.

• ANSI/AAMI RD61:2006 - Concentrates for hemodialysis
  AAMI's standard covering concentrates for hemodialysis was revised to help prevent the use of hazardous options that can result in poisoning as a result of the formulation of dialysate with water that contains high levels of certain contaminants as well as dangerous treatment resulting from the use of the wrong contaminants.

• AAMI RD16:2007 - Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
  Hemodialyzers are incorporated into a patient's bloodstream to supplement kidney function. A faulty device or improper operation of the device may cause serious adverse effects such as hemorrhage, low blood pressure, infection or illness due to inadequate treatment or retention in the bloodstream of waste products.

  AAMI's Renal Disease and Detoxification Committee (RDDC) revised AAMI RD16 to promote adequate labeling of these devices, uniformity of testing and reporting of device performance characteristics and acceptable safety and performance of these devices.

  "The hemodialyzer, or 'artificial kidney,' remains a key component in the treatment of renal failure patients. More than one billion treatments are performed per year worldwide using this technology," said Conor Curtin, cochair of AAMI's RDDC.

  "[AAMI] RD16 is important in gathering - from both U.S. and international experience - minimum quality requirements and expected performance indicators for this technology. The standard incorporates best practices and understandings of manufacturers, clinical practitioners and end-users."

• AAMI RD17:2007 - Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
  The RDDC also revised AAMI RD17:2007 after noting that faulty blood tubings for hemodialyzers can cause serious adverse effects such as blood loss, air embolism, infection or injury to the operator of the hemodialyzer circuit. The revised standard promotes adequate labeling of these devices, uniform testing and reporting effectiveness.

  "The standard was revised to incorporate learning from U.S. and worldwide experience and contains two important new safety warnings related to locking connectors and air detectors," said Curtin.

In addition to the four newly revised dialysis standards, the dialysis collection includes ANSI/AAMI RD52:2004 - Dialysate for hemodialysis, ANSI/AAMI RD47:2003 - Reuse of hemodialyzers and ANSI/AAMI/RD5:2003 - Hemodialysis systems.

Source: Association for the Advancement of Medical Instrumentation (AAMI).