CMS SOM App. H, Tag V304

dialysis facility that reuses hemodialyzers and bloodlines must adhere to the following

reprocessing guidelines:

(1) Meet the requirements of AAMI published in “Reuse of Hemodialyzers,” third

edition, ANSI/AAMI RD47:2002 and RD47:2002/A1:2003. 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, 7500 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://code_of_regulations/ibr_locations.html. Copies may be purchased from the

Association for the Advancement of Medical Instrumentation, 3300 Washington

Boulevard, Suite 400, Arlington, VA 22201- 4598.

Interpretive Guidance § 494.50(b)

The AAMI “Reuse of Hemodialyzers,” third edition, ANSI/AAMI RD47:2002/A1:2003 is

incorporated by reference. The recommendations are provided in the “Regulation” column and

carry the full weight of regulation. Explanatory language from the AAMI recommendations and

portions of the AAMI rationale for the development and provisions of the recommended practice

are provided in the “Interpretive Guidance" column as an aid to understanding the regulation.

In some cases, the AAMI identification numbers may appear out of order, as they have been

rearranged for better flow with the survey process. While exact language from the AAMI

document has been incorporated as regulation, the language in the “Interpretive Guidance”

column has been edited for clarity, brevity, and to minimize redundancy.

Page 119 of 420

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 RD47:2002/A1:2003

11 Reprocessing

The multiple use of a dialyzer begins with the labeling of the new dialyzer (see AAMI section 10)

and then continues with the reprocessing procedures described in this section. Preparation of the

reprocessed dialyzer for the next dialysis is described in AAMI section 12. The cycle is repeated

after the next use of the dialyzer until the dialyzer does not meet the criteria for continued use.

The results of the tests and the signature or other unique means of identifying the person

performing each step should be maintained in a permanent record (see AAMI section 4.2).

Completion of all reprocessing steps, tests, and inspections should be documented in the

reprocessing record, accompanied by the signature or other unique means of identification of the

person completing them. When appropriate for the reprocessing procedure in use, all dialyzer

manufacturer’s instructions regarding reuse should be carefully followed.