Or. Admin. R. 333-700-0125

Current through Register Vol. 63, No. 9, September 1, 2024

Section 333-700-0125 - Reuse of Hemodialyzers and other Dialysis Supplies

If the facility reuses hemodialyzers, the facility shall conform to the following:

(1) Meet the requirements of AAMI published in "Reprocessing of Hemodialyzers," ANSI/AAMI RD47:2008/(R)2013, adopted by reference;

(2) Procedure for chemical germicides: To prevent any risk of dialyzer membrane leaks due to the combined action of different chemical germicides, dialyzers shall only be exposed to 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:

(a) Shall take appropriate blood cultures at the time of a febrile response in a patient; and

(b) If pyrogenic reactions, bacteremia, or unexplained reactions associated with ineffective reprocessing are identified, the reuse of hemodialyzers in that setting shall be terminated and the facility shall not continue reuse until the entire reprocessing system has been evaluated;

(4) Transducer filters: To control the spread of hepatitis, transducer filters shall be changed after each dialysis treatment and shall not be reused; and

(5) Bloodlines: If the facility reuses bloodlines, it shall:

(a) Limit the reuse of bloodlines to the same patient;

(b) Not reuse bloodlines labeled for "single use only";

(c) 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

(d) Follow the FDA-accepted manufacturer's protocol for reuse of that bloodline.

Or. Admin. R. 333-700-0125

PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12; PH 18-2019, amend filed 10/01/2019, effective 1/1/2020

Publications: Publications referenced are available from the agency.

Statutory/Other Authority: ORS 441.015 & 441.025

Statutes/Other Implemented: ORS 441.025 & 442.015