Protection of dialysis patients

1
Protection of dialysis patients

• Tomasz Mroczek, WSZiM, 1st sem.
• Resolution of the Council 12 June 1986
• Directive 80/778/EEC
• (Official Journal No L 229, 30. 8. 1980, p.11

2
Preface

• Resolution of the Council and of the
  Representatives of the Governments of the member
  States meeting within the Council of 12 June 1986
  concerning the protection of dialysis patients by
  minimizing the exposure to aluminum
• Objective
  To lay down recommendations concerning the
  purity of solutions and water used in dialysis,
  in order to protect dialysis patients

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Mechanism of dialysis

• Dialysis are being initiated when patient suffer
  from renal disease.
• The scheme of dialysis process
• Dialysator - the device where blood is being
  cleaned.
• Dialysis machine - transport of blood and dilute
  water (permeate)
• Dialysator with its semipermeable membrane
• Mechanisms of filtration and diffusion
• Solutes pass in 2 directions
• Warning Purity of water is crucial for patients
  health and safety.

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Definitionsof expressions used in the Directive

• concentrated solution for hemodialysis
• diluting water
• dilute solutions for hemodialysis
• Water Treatment System,

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Processes

• Production of the concentrated solution on spot
• Production in distant plants
• Central distribution - delivering through pipes
• Deliveries in plastic containers
• Water loop - for transporting diluting water

6
Aluminium toxicity
7
Present situation in Poland

• Dialysis standards recommended by MOH say
  nothing about water
• Sanitary authorities use own standards (for
  drinking water) and are focused on bacteria
  contamination
• There are no obliging standards for chemical
  consistence of water for dialysis

8
Real life

• Concentrated solutions are being produced in
  small workshops, practically without any
  supervision

9
Directive contents Memebr states ahould take
steps to ensure thath

• The total amount of aluminium present in the
  concentrated solution for haemodialysis supplied
  for the purpose of preparing dilute solutions
  does not contribute more then 10 ?g/l to the
  concentration of aluminium in the dilute solution
  for haemodialysis
• diluting ater complies at least with all the
  requirements of Directive (Nrxxxx, that concerned
  drinking water).
• Diluting water is appropriately treated to reduce
  the aluminium level if if the latter exceeds 30
  ?g/l
• treatment of the water is also envisaged
  depending on the amount of aluminium introduced
  by the concentrate and equipment.
• These levels are appropriately monitored

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The authorities responsible for water
distribution and renal analysis shall

• Inform all renal dialysis units, if possible in
  advance , of any important change in the
  treatment of water which might increase the
  aluminium level in the water distributed and also
  of any accidental pollution of the water
  disttributed
• study the possibility of replacing aluminium
  salts in the treatments of water
• Shall regularly monitor aluminium in the plasma
  or serum of these patients in order to attempt to
  protect against the toxic effects of alluminium

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Implications

• Nobody checks these levels now
• This directive will impose many additional,
  responsible, duties on managers of the dialysis
  centers and on medical staff
• As the tap water is usually very bad it may cause
  additional pressure on water-suppliers.

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Consequent steps

• To adopt these directives to countrys official
  medical standards
• Supply all interested health centers with
  appropriate and accurate measure instruments
• The centers technical staff has to undergo
  appropriate training.