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:
Cold (approx. 20 °C)
For steam sterilization the following parameters are common in Germany:
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.
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.