ANSI/AAMI RD47 – Reuse of Hemodialyzers

This recommended practice published by AAMI is one of the most recognized documents of the dialysis industry within the field of reprocessing. It has been adopted by CMS and is used as a condition of coverage for dialysis reimbursement. If an inspector from CMS visits a dialysis facility that performs dialyzer reprocessing, personnel will be asked to demonstrate that the procedures and actions within the dialysis facility meet the requirements of RD47.

This recommended practice has been revised several times since its original development and publication. The latest version is “ANSI/AAMI RD47:2002 & RD47:2003/A1:2003.” The revisions to this document are a result of new technology and comments received from users of the document.  User input is always welcomed and will be considered at the next revision.

Listed below are some topics that are covered to assist providers on how to properly and effectively conduct reuse of hemodialyzers.  Sections include:

  • Records- what records should be maintained and presented to the FDA when they visit the facility.
  • Personnel qualifications- what level of training is required and how a person should be considered qualified.
  • Patient considerations- informed consent and treatment of hepatitis patients.
  • Equipment- whether using manual equipment or fully automated equipment the results should be the same.
  • Physical plant and environmental safety considerations- Lay out of the room, ventilation, and safe chemical airborne levels.
  • Reprocessing supplies- inventory control.
  • Hemodialyzer labeling- when to label, what should be on the label, and how to deal with same name labels.
  • Reprocessing- considerations such as testing and header cleaning that should be taken during the reprocessing procedure.
  • Preparing for dialysis and testing for chemical germicides including potentially toxic residues- Precautions to take when setting up the dialyzer for the next use, the test for residuals, and understanding ‘rebound’ and how to prevent it.
  • Monitoring- what to look for in terms of patient reactions and how to recognize if the patient symptom is a result of reuse or some other dialysis procedure.
  • Quality Assurance- Auditing to be certain that the program is producing the necessary result(s).

Lastly, the Standard includes several Annex’s which provide rationale for the development along with many of the thoughts that the committee used in determining and deciding on best dialyzer reuse policies and practices.




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