OAR 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.

Source: Rule 333-700-0125 — Reuse of Hemodialyzers and other Dialysis Supplies, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-700-0125.

333‑700‑0000
Statement of Purpose 333‑700‑0004
Referenced Codes and Standards 333‑700‑0005
Definitions 333‑700‑0010
Application for Licensure 333‑700‑0015
Annual License Fee 333‑700‑0017
Application Review 333‑700‑0018
Approval of License Application 333‑700‑0019
Denial of License Application 333‑700‑0020
Expiration and Renewal of License 333‑700‑0025
Denial or Revocation of a License 333‑700‑0030
Discontinuance and Recommencement of Operation of Outpatient Renal Dialysis Facilities 333‑700‑0035
Return of Facility License 333‑700‑0040
Classification 333‑700‑0045
Hearings 333‑700‑0050
Adoption by Reference 333‑700‑0053
Complaints 333‑700‑0057
Investigations 333‑700‑0060
Surveys 333‑700‑0061
Violations 333‑700‑0062
Informal Enforcement 333‑700‑0063
Formal Enforcement 333‑700‑0064
Civil Penalties 333‑700‑0072
Waivers 333‑700‑0073
Outpatient Mobile Dialysis 333‑700‑0075
Administrative Authority and Management 333‑700‑0080
Quality Assessment and Performance Improvement 333‑700‑0085
Patient Care Plan 333‑700‑0090
Medical Records 333‑700‑0095
Medical Director of an Outpatient Renal Dialysis Facility 333‑700‑0100
Patient Care Staff 333‑700‑0105
Minimal Service Requirements for an Outpatient Renal Dialysis Facility 333‑700‑0110
Infection Control 333‑700‑0115
Patients’ Rights, Responsibilities and Family Education 333‑700‑0120
Facility Safety and Emergency Preparedness 333‑700‑0125
Reuse of Hemodialyzers and other Dialysis Supplies 333‑700‑0131
Physical Environment Requirements
Last Updated

Jun. 8, 2021

Rule 333-700-0125’s source at or​.us