Consensus Statement on the Reuse of Haemodialysers
- May 1996

1. These guidelines apply to the reuse of haemodialysers for the same patient that each dialyser was originally used for. The Joint Subcommittee strongly recommends against the reuse of a given dialyser for more than one patient.
   
   
2. Dialyser reuse has been widely practiced in the USA and Australia, and carried out successfully in some Units for over 20 years.
   
   
3. It is not improper to reuse a dialyser simply because the manufacturer states it is disposable. Ideally the manufacturer should provide information about the materials used in the dialyser and its reaction to commonly used sterilants.
   
   
4. Reuse procedures may be harmful to patients if not carried out correctly. However, there are dangers in any highly technological procedure including dialysis with new dialysers.
   
   
5. Long term use of reprocessed dialysers is probably safe, based on internationally published work and local experience.
   
   
6. Machines for automated reprocessing of dialysers have been proven to be effective, probably more so than manual reprocessing methods, probably because of the greater volume of cleansing/sterilising agent used. They also reduce inconvenience to staff as well as exposure of staff to sterilants.
   
   
7. There may be some advantages to patients from reuse. Reused dialysers are possibly more biocompatible although the issue of whether reprocessed dialysers induce fewer symptoms remains unresolved. The institution of reuse may be necessary before a dialysis unit can afford to utilise special purpose expensive dialysers.
   
   
8. Particular attention should be paid to the quality of the water used in (automated) reprocessing [American standards (AAM1) for 'water for reuse' are less than 200 cfu/ml total viable microbial counts]. This testing should be performed at least every 3 months.
   
   
9. Concern about reuse stems from the possibility that:
   1. Patients may suffer from inadequate sterilisation, inefficient dialysis or from complications relating to the sterilising agent.
      1. Sterilisation must be ensured by using adequate concentrations of chemical sterilants - eg. 4% for formaldehyde or 3% of the original peracetic acid solution (0.15% peracetic acid). Any evidence of bacteraemia or pyrogenic reactions should be promptly investigated.
      2. It is not feasible nor necessary for each dialyser to be tested biochemically for efficiency. All dialysers should be checked visually prior to each use. Most automated reprocessing machines provide both pressure (ruptured fibre) and volume (clotted fibre) checks. Measurements of dialyser volume, clearance and ultrafiltration characteristics should be carried out on a proportion of dialysers as a quality assurance check or to investigate any doubts about continued efficiency.
      3. Problems related to the sterilant include direct toxicity from inadvertent exposure and indirect effects such as immunological reactions and possible cancer. Although reuse has been demonstrated to favour the development of certain antibodies (eg. anti-N antibodies with formalin) these have rarely been demonstrated to be harmful and can be avoided by adequate rinsing or use of an alternative sterilant. Precautions should be taken to reduce exposure to chemical sterilants as much as possible (see below). Testing is required to ensure residual sterilant is reduced to safe levels prior to every dialysis (eg use of Formalert or Renalin test strips).
   2. Staff may experience ill effects from sterilising agents. Precautions can include the use of closed reuse systems, adequate ventilation, protective clothing and monitoring of environmental conditions.
      
      
10. Units practising reuse must:
    1. have an adequate training programme for patients and staff.
    2. develop written protocols for how the procedure is to be carried out including appropriate tests of safety and efficiency as well as statements about who is to be excluded from the reuse programme, eg. patients with Hepatitis B and C.
    3. keep written records of each reprocessing procedure including complications during the subsequent dialysis. Two staff members are to identify each dialyser and check and sign that the patient is receiving the correct dialyser and that it is free of residual sterilant.