(a) Standard: General requirements for the reuse of hemodialyzers and bloodlines. Certain hemodialyzers and bloodlines—

(1) May be reused for certain patients with the exception of Hepatitis B positive patients;

(2) Must be reused only for the same patient; and

(3) Must be labeled for multiple reuse in accordance with the premarket notification provisions of section 510(k) of the Food, Drug, and Cosmetics Act and 21 CFR 876.5860.

(b) Standard: Reprocessing requirements for the reuse of hemodialyzers and bloodlines. A 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://www.archives.gov/federal__register/code__of__federal__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.

(2) Reprocess hemodialyzers and bloodlines—

(i) By following the manufacturer's recommendations; or

(ii) Using an alternate method and maintaining documented evidence that the method is safe and effective.

(3) Not expose hemodialyzers to more than one chemical germicide, other than bleach (used as a cleaner in this application), during the life of the dialyzer. All hemodialyzers must be discarded before a different chemical germicide is used in the facility.

(c) Standard: Monitoring, evaluation, and reporting requirements for the reuse of hemodialyzers and bloodlines. In addition to the requirements for hemodialyzer and bloodline reuse specified in paragraphs (a) and (b) of this section, the dialysis facility must adhere to the following:

(1) Monitor patient reactions during and following dialysis.

(2) When clinically indicated (for example, after adverse patient reactions), the facility must—

(i) Obtain blood and dialysate cultures and endotoxin levels; and

(ii) Undertake evaluation of its dialyzer reprocessing and water purification system. When this evaluation suggests a cluster of adverse patient reactions is associated with hemodialyzer reuse, the facility must suspend reuse of hemodialyzers until it is satisfied the problem has been corrected.

(iii) Report the adverse outcomes to the FDA and other Federal, State or local government agencies as required by law.