CMS SOM App. H, Tag V176

(a) Standard: Water purity. Water and equipment used for dialysis meets the water and

dialysate quality standards and equipment requirements found in the Association for the

Advancement of Medical Instrumentation (AAMI) publication, “Dialysate for

Page 33 of 420

hemodialysis,” ANSI/AAMI RD52:2004. The Director of the Federal Register approves this

incorporation by reference in accordance with 5 U.S.C. 552 (a) and 1 CFR Part 51. This

publication is available for inspection at the CMS Information Resource Center, 75000

Security Boulevard, Central Building, Baltimore, MD or at the National Archives and

Records Administration (NARA). For information on the availability of this material at

NARA, call 202-741-6030, or go to:

http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. Copies

may be purchased from the Association for the Advancement of Medical Instrumentation,

1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795.

Interpretive Guidance § 494.40(a)

The practice guideline of the Association for the Advancement of Medical Instrumentation

(AAMI) for “Dialysate for hemodialysis” (ANSI/AAMI RD52:2004) is incorporated by reference

at 42 CFR 494.40 and is reflected in the tags and the interpretative guidelines at V176 to V278.

AAMI is a professional organization in which committees composed of representatives of the

industry, providers, and regulatory agencies develop voluntary guidelines for medical products

and procedures.

Some explanatory language from ANSI/AAMI RD52:2004 and from the Annex to that document

has been included below as guidance to surveyors.

Note: When words are inserted or altered in a direct quotation, square brackets—[]—are

placed around the change. The brackets enclose words intended to explain the quote or to help

integrate the quote into the guidance.

AAMI standards, to be fully understood, should be read in their entirety and anyone attempting

to apply AAMI standards and recommended practices is encouraged to obtain the complete

standard. AAMI disclaims responsibility for any characterization or explanation of its standards

and recommended practices that were not developed and communicated in accordance with

AAMI procedures for the official interpretation of technical documents.

Grouping of AAMI sections within a given tag may be non-consecutive based on its relevance to

the standard being addressed. For example, tag V236 for additives incorporates sections 5.4.4.1

(concentration jugs), 5.4.5 (additives – labeling), and 6.4.2 (additives) from the RD52:2004

requirements.