General information general information
In the European Community and in the associated member countries the Medical Device Directive (MDD) is finally implemented since 1998. All sterile products being used at a human being are defined as medical devices according to the MDD. To produce sterile products the validation of a sterilization process is required. It is not sufficient to commission the sterilizer- often misinterpreted as “validation”. A sterilization process consists of the following components:
- 1. sterilizer with all accessories and supply ingredients
- 2. sterilization program selected
- 3. type of goods sterilized
- 4. packaging material
- 5. load configuration
If one of those components is modified (especially other types of goods) a new validation of the process is required.
The validation of a sterilization process is a test report which guarantees that all goods being
Sterilized have achieved a sterility assurance level (SAL) of 10-6 CFU per part.
If those goods are sold to a third party (brought to the market) according to the MDD the validation must be checked by a Notified Body. This process is called “conformity process”. According to the second modification of the MDD health care facilities that re-process their sterile goods do not bring products to the markets. The re-processing is classified as a “maintenance process”. Therefore an individual conformity process by a notified body is not required in this case. However, for the application of those goods used at the patient, health care facilities require the same validation, monitoring and documentation procedures which have to be carried out under the responsibility of the health care facility:
The validation has to be carried out as follows:
1. commissioning of the sterilizer with a type test according to the specification of the manufacturer
validation of the sterilization process including all goods, packaging etc. by parameter testing, the use of process challenge devices (PCDs) with chemical and/or biological indicators to proof the sterilization in all worst case areas of the load. Under certain sterilization conditions for complex goods, parametric release may not be sufficient and biological-indicator suspensions have has to be used at worst case places for monitoring and validation.
3. Rport of the commissioning and validation process according to the technical state of the art
Routine monitoring has to be carried out during every cycle to proof that each cycle is running according to the validated process. Typically temperature and pressure-time-diagrams and also the penetration of the sterilant has to be monitored with a representative process challenge device (PCD).
All relevant data collected during the monitoring process have to be documented at a documentation chart i.e. the batch number for each cycle, the production date, the responsible person, and – if applicable – the expiry date. The same data but at least the batch number has to be documented on each pack.
In case a patient gets a secondary infection, legal proceedings may be raised and the health care facility has to provide data to proof that the re-processing of sterile goods has been carried out according to the latest technology standard.
This standard is reflected in local laws and in European and international standards like:
- · EN-ISO 14937 Design, validation and routine monitoring for sterilization processes
- · EN-ISO 11135 Requirements for the development, validation and routine control of ethylene oxide sterilization processes
- · EN-ISO 11137 Radiation sterilization
- · EN ISO 17665 Requirements for the development, validation and routine control of steam sterilization processes
- · EN 556 Definition of sterility assurance level
The gke application laboratory may provide more detailed information about validation, monitoring and documentation of your individual sterilization process.