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Hygienic safety through correct processing.

PROCESSING OF MEDICAL PRODUCTS IN GERMANY

HYGIENE AND SAFETY

The hygiene requirements for processing medical devices are defined in the joint recommendation of the Commission on Hospital Hygiene and Infection Protection (KRINKO, German CDC) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM, German FDA). The reference to this recommendation in the German Medical Devices Operator Ordinance (MPBetreibV) lends it legal character.

In Germany, automated processes are favored for processing of medical devices. In particular, cleaning and disinfection should always be carried out automatically for reasons of process safety. Manual pre-cleaning steps should also be avoided if possible. This principle is only to be deviated from if the medical devices cannot be processed in the washer-disinfector (WD), for example due to material or design reasons. For thermolabile medical devices, chemo-thermal automated cleaning/disinfection is preferred, whereby the temperature of 65 °C is not exceeded. In Germany special load carriers for MIS instruments are in use for processing medical devices with lumen. There are special load carriers which have nozzles for irrigation of hollow instruments.

 

For automated cleaning with subsequent thermal disinfection, the following parameters are customary in Germany:

 Process step

 Water quality

 Time

 Temperature

 Pre-cleaning

 Tap water

 5 min

 Cold (approx. 20 °C)

 Cleaning

 Deionized water

 10 min

 55 °C

 Rinsing

 Deionized water

 2 min 

 

 Disinfection

 Deionized water

 5 min

 90 °C

 Drying

-

 15 min

 90 °C

 

For steam sterilization the following parameters are common in Germany:

Process step

Time

Temperature

 Sterilization

 5 min

 134 °C

 Sterilization (prion-program)

 18 min

 134 °C

 

Besides neutral, alkaline, and enzymatic agents, mildly alkaline products are preferred used for cleaning in Germany.

Spray disinfection is out of the question for reasons of occupational safety.

In Germany, medical devices are to be cleaned first and disinfected afterwards. This is to prevent a possible fixation of proteins through the disinfection process. As a further principle: Only clean medical devices can be disinfected or sterilized effectively. After cleaning, disinfection is then also carried out for reasons of personnel protection. Usually, both processes take place in the WD.

The clean and disinfected medical devices are visually checked for cleanliness afterwards. Subsequently, maintenance or oiling of the medical devices is carried out if necessary. In the next step, the medical devices are packaged and finally sterilized.

For the German market, the disinfection performance is tested with the standard test germ E. faecium. Acceptance criterion for a successful disinfection is the reduction of germs by 5 log levels.

Thermal processing processes (thermal disinfection and steam sterilization) must be checked thermoelectrically, if measuring at the critical points of the medical device is possible.

The microbiological test shows that the disinfection and sterilization time and temperature on the medical device was sufficient to kill the test germs.

 

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AT A GLANCE

HYBETA - YOUR PARTNER FOR VALIDATION PROCESSES

  • VALIDATION OF THE PROCESSING OF MEDICAL DEVICES FOR MANUFACTURERS

    We validate manual and machine cleaning and disinfection processes for you and, if required for your medical device, of course also steam sterilization according to current norms and standards.

  • STANDARD AND PRACTICAL PROCESSING INSTRUCTIONS

    Do you need support in the creation of standard-compliant, practical and user-friendly processing instructions? Of course we take into account your customers’ usual and established processing processes. We are pleased to check your existing processing instructions.

  • ADVICE ON MEDICAL DEVICE GROUPING AND DETERMINATION OF WORST-CASE MEDICAL DEVICES

    We are happy to help you forming medical device groups and provide you with a risk matrix to determine the worst-case medical devices.

  • SUPPORT DURING PRODUCT DEVELOPMENT

    Incorporating hygienic processing during the medical device design phase - when using materials, as well as design considerations - prevents subsequent difficulties. We would be happy to advise and to carry out pre-tests for you.

SPEAK TO US

Nana Schürjann

B. Sc. Hospital hygiene
Head of preparation validation for manufacturers

HYBETA GmbH
Nevinghoff 20
48147 Münster
www.hybeta.com

fon + 49 (0) 2 51 28 51 – 147
mobil + 49 (0) 1 51 18 86 12 56
emailn.schuerjann@hybeta.com
Mehr wissen. Weiter denken.

INTERACTIVE CHECKLIST

Use our interactive checklist to check whether and to what extent there is a need for improvement with regard to the hygienic processing validation of your medical devices and to the corresponding processing instructions.

TO THE INTERACTIVE CHECKLIST

FAQ

You will find the most important questions and answers at a glance here.

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NORMS AND GUIDELINES

Here you can find out what the legal requirements for technical hygiene are in detail.

+ To the guidelines