This area has been designed specifically for dialysis professionals in the medical device community.  It serves as a resource on dialysis standards, publications, and contacts for other groups involved in medical device dialysis activities.  The site also provides information on FDA and regulations affecting medical device manufacturers.

AAMI Dialysis Standards

  • AAMI Dialysis Collection
    Six of the 11 standards were published in 2014 (23500, 11663, 13958, 13959, 26722, and TIR58). Consider the CD, which includes additional resources at no extra cost. Order Code: DSBK15, DSBK15-PDF or DSBKCD.  Link here.

  • Become involved in AAMI's Dialysis Standards Committees
    Committees made up of volunteers are the heart of the AAMI Standards Program. Committee members make recommendations on the need for new standards and other technical publications, determine when a document needs to be revised, draft new documents, and develop committee and public consensus on drafts.
    To join:

AAMI Dialysis Publications

  • Dialysis Water and Dialysate Recommendations: A User Guide
    This book provides a side-by-side comparison of the CMS regulations and interpretive guidance for the Condition of Water and Dialysate Quality and the section related to water and dialysate from the Condition of Care at Home with the suite of ISO Standards that have been adopted as replacement for ANSI/AAMI RD52:2004.
  • Acute Hemodialysis: Survey Readiness Handbook
    This handbook provides a clear explanation of the federal requirements applicable to the acute hemodialysis service and an overview of the expectations for compliance with the standards of the four accreditation organizations that provide quality oversight of hospitals
  • Hemodialysis Horizons
    This is a special publication from AAMI intended to frame important issues affecting the hemodialysis field and to contribute to the safety of patients around the world.

FDA

Dialysis Links