N.J. Admin. Code § 8:43A-24.9

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:43A-24.9 - Reuse of dialyzers

(a) If dialyzers are reused, reuse shall conform with the guidelines in the Association for the Advancement of Medical Instrumentation (AAMI) publications, "Hemodialyzers," 2<nd> Edition and Amendment, RD16:1996 and A1:2002, "Hemodialyzer blood tubing," 2<nd> Edition and Amendment, RD17:1994 and A1:2002, and "Reuse of hemodialyzers," 3<rd> Edition and Amendment, RD47:2002 and A1:2003, incorporated herein by reference , as amended and supplemented.

1. AAMI publication s can be obtained from;

Association for the Advancement of Medical Instrumentation

901 N. Glebe Road, Suite 300

Arlington, VA 22203

or at the AAMI website at http://www.aami.org .

(b) The facility's policy on dialyzer reuse shall be explained to all renal dialysis patients.

1. Patients who consent to reuse shall sign an informed consent form informing them of the risks associated with dialyzer reuse.

2. If the patient declines reuse, arrangements shall be made for the patient to receive single-use treatment in the unit.

(c) Reuse of bloodlines and transducer filters is prohibited with the exception of home dialysis equipment that is for the use of a single dialysis patient and is specifically designed by the manufacture to permit the reuse of bloodlines.

(d) Water used in dialyzer reprocessing systems shall be analyzed for endotoxins from the water source outlets at least monthly and more often as necessary.

(e) In the case of centralized reuse processing, the facility is responsible for the quality of the reuse dialyzer and performance standards.

N.J. Admin. Code § 8:43A-24.9

Amended by 54 N.J.R. 60(a), effective 1/3/2022