TITLE 42 - PUBLIC HEALTH

CHAPTER IV - CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - MEDICARE PROGRAM

PART 405 - FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

subpart u - CONDITIONS FOR COVERAGE OF SUPPLIERS OF END - STAGE RENAL DISEASE (ESRD) SERVICES

405.2150 - Condition: Reuse of hemodialyzers and other dialysis supplies.

An ESRD facility that reuses hemodialyzers and other dialysis supplies meets the requirements of this section. Failure to meet any of paragraphs (a) through (c) of this section constitutes grounds for denial of payment for the dialysis treatment affected and termination from participation in the Medicare program.

  (a) Standard: Hemodialyzers. If the ESRD facility reuses hemodialyzers, it conforms to the following: (1) Reuse guidelines. Voluntary guidelines adopted by the AAMI (Reuse of Hemodialyzers, second edition). Incorporation by reference of the AAMI's Reuse of Hemodialyzers, second edition, 1993, was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.1 If any changes in Reuse of Hemodialyzers, second edition, are also to be incorporated by reference, a notice to that effect will be published in the Federal Register.

1The publication entitled Reuse of Hemodialyzers, second edition, 1993, is available for inspection at the CMS Information Resources Center, 7500 Security Boulevard, Baltimore, MD 212441850 and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 2027416030, 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 222014598.

  (2) Procedure for chemical germicides. To prevent any risk of dialyzer membrane leaks due to the combined action of different chemical germicides, dialyzers are exposed to only one chemical germicide during the reprocessing procedure. If a dialyzer is exposed to a second germicide, the dialyzer must be discarded.

  (3) Surveillance of patient reactions. In order to detect bacteremia and to maintain patient safety when unexplained events occur, the facility (i) Takes appropriate blood cultures at the time of a febrile response in a patient; and (ii) If pyrogenic reactions, bacteremia, or unexplained reactions associated with ineffective reprocessing are identified, terminates reuse of hemodialyzers in that setting and does not continue reuse until the entire reprocessing system has been evaluated.

  (b) Standard: Transducer filters. To control the spread of hepatitis, transducer filters are changed after each dialysis treatment and are not reused.

  (c) Standard: Bloodlines. If the ESRD facility reuses bloodlines, it must (1) Limit the reuse of bloodlines to the same patient; (2) Not reuse bloodlines labeled for single use only; (3) Reuse only bloodlines for which the manufacturer's protocol for reuse has been accepted by the Food and Drug Administration (FDA) pursuant to the premarket notification (section 510(k)) provision of the Food, Drug, and Cosmetic Act; and (4) Follow the FDA-accepted manufacturer's protocol for reuse of that bloodline.

[52 FR 36935, Oct. 2, 1987, as amended at 55 FR 18335, May 2, 1990; 60 FR 48044, Sept. 18, 1995; 69 FR 18803, Apr. 9, 2004]