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Hygiene - Fresenius Medical Care

Modern products and efficient procedures for hygiene management

  • Biofilm: prevention instead of reaction
  • Quality assurance
  • Cleaning and disinfecting system hydraulics
  • The surface disinfection of medical devices

Hygiene aspects in dialysis

Hygiene aspects in dialysis

Disinfection can be based either on physical or on chemical methods. It is also possible to combine these two methods, a procedure which is often used in treatment machines and dialysis systems.

In dialysis, alongside bactericidal efficiency, the “limited spectrum of virucidal activity” is of particular interest with regard to disinfection. Hepatitis B, hepatitis C and HI viruses are enveloped viruses, which can be inactivated more easily than non-enveloped viruses (e.g. polioviruses). The hygiene commission at the German Robert Koch Institute recommends that products which are demonstrably able to inactivate surrogate viruses can be considered to have a “limited spectrum of virucidal activity” and are therefore effective against enveloped viruses1.

The spectrum of virucidal activity
Test viruses to declare “limited spectrum of virucidal activity”1,2
  • Bovine Viral Diarrhoea Virus (BVDV)
  • Vaccinia virus (Elstree strain or MVA)
Test viruses to declare “virucidal”1,2
  • Adenovirus (adenovirus type 5, adenoid 75 strain)
  • Papovavirus (simian virus 40 [SV40], 777 strain)
  • Poliovirus (poliomyelitis vaccine strain type I, LSc-2ab strain)
  • Murine Norovirus (MNV), strain S99
Test virus to declare “virucidal” according to DIN EN 14476 
  • Poliovirus type 1, adenovirus type 5, murine norovirus; at disinfection temperatures of more than 40°C: Murine parvovirus, Crawford strain


Hygiene management

Hygienic measures are measures to maintain the health of people. The presence of microorganisms can negatively affect the treatment quality and health of dialysis patients. Personnel employed in the public health sector are also exposed to the risk of infection. These facts can only be efficiently counteracted by appropriate hygiene management.

The modern products and efficient procedures of Fresenius Medical Care support you in achieving proper hygiene management.

The sections below will give you a summary of the essential hygienic aspects in dialysis and extracorporeal treatment therapies.

Prophylaxis and quality assurance


Biofilm prevention instead of reaction

ISO 23500:20144 requires regular prophylactic disinfection of the reverse osmosis unit and the permeate ring main to minimise the formation of a biofilm.

Suitable regular disinfection measures are chemical or hot water. Ideally, the measure to be used should already be determined in the planning phase of a dialysis unit.

Quality assurance

Quality assurance

To meet the requirements of a quality management system, the chemical and microbiological quality of permeate, dialysis concentrate and dialysate must be monitored regularly.

Cleaning and disinfecting

Cleaning and disinfecting system hydraulics

In order to prevent microbiological loads, the hydraulics of the dialysis systems must be disinfected after each treatment.

In addition, dialysis systems should be subject to a regular cleaning programme to remove organic components.

The surface disinfection of medical products

The surface disinfection of medical devices

In dialysis, there is a high risk of the transfer of microorganisms, caused by contact with contaminated surfaces. The outside surfaces of a dialysis system may be contaminated, therefore requiring disinfection measures.

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