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Recommendations by the Quality Task Group
[16] Quality Assurance on the Unclean Side of a CSSD

QUALITY ASSURANCE does not begin only after devices are returned, following preparatory tasks, automated cleaning and disinfection with subsequent inspection, but rather begins already at the time of purchasing and of handing in used medical devices for reprocessing.

In Issue 5, 2000 (13), the most important features of quality assurance on the clean side of a CSSD were already described in detail, and in Issue 4, 1999 (6), it was emphasised how important it is to clarify already at the time of purchasing medical devices the procedures that can be used for reprocessing. Here one must ensure that these procedures are also available in the respective establishment.

In Issue 3, 1999 (5,) important aspects of cooperation with the surgical departments were outlined, because it is already at the time of handing back devices that the preconditions for further problem-free processing in the CSSD are defined. Correct return of devices can avoid or reduce not only additional procedural steps but also endangerment to the CSSD personnel.

As a continuation of Recommendation No. 13 dealing with quality assurance on the clean side, the forthcoming issues will deal with the various aspects relating to the unclean side. A certain amount of overlapping and repetition is unfortunately inevitable. For the various themes brief test criteria are given with which each CSSD has to deal, in order to formulate an appropriate quality assurance concept tailored to its individual situation as regards design, personnel and furnishings.

Documentation for Formulation of a Quality Assurance Concept
There are certain types of documentation that must be taken into account for formulation of a quality assurance concept in the CSSD as well as others that may be a valuable source of help. The LEGAL STIPULATIONS in the Medical Devices Directive (MPG), the Medical Devices Operator Ordinance (MPBetreibV), Infection Protection Act (IfSG), Accident Prevention Ordinance (UVV), Hazardous Substances Ordinance (TRGS 555) constitute the basis for quality assurance.

Furthermore, there are continually updated LISTS of the Robert Koch Institute (RKI) governing equipment, procedures and disinfectants to be used during epidemics as well as of the German Society for Hygiene and Microbiology (DGHM) on disinfectants for disinfection of hands, surfaces, instruments and laundry during routine hospital operation. International working groups are compiling standards for validation of automated cleaning and disinfection procedures; European standards are already available for verification of sterilisers and sterilisation processes.

Important hygiene principles can be consulted in the GUIDELINE of the RKI "Guideline for Hospital Hygiene and Infection Prophylaxis" as well as in the guidelines of the German Society for Hospital Hygiene (DGKH). The loose-leaf set* "Investigation of Washer-Disinfectors" describes current test methods for automated processing procedures.

The RECOMMENDATIONS OF THE QUALITY TASK GROUP in the German Society for Sterile Supply (DGSV) focus in particular on the practical aspects and make proposals for implementation of the guidelines for processing medical devices.

The task group AKI "Correct instrument processing" deals mainly with value preservation as well as with material behaviour and gives advice on prevention of damage to medical devices.

Several working groups are investigating the suitability of medical devices for processing as well as with test methods described:

• methods for investigating the patency of medical devices, which is a precondition for successful cleaning
• methods for investigating efficacy of automated processed ranging from the type test to routine testing and
• methods for checking for residues, especially for protein residues.

The results of the studies are published, inter alia, in the PROFESSIONAL JOURNALS "Infection Control and Healthcare", "Central Service" and "Aseptica". In addition, the MANUFACTURERS provide detailed information on their products.

All the documentation mentioned should be available to the CSSD MANAGEMENT and should be imparted in excerpts in staff training courses.

Documentation Based on a Quality Manual
Quality assurance is enshrined in legislation and is therefore indispensable in any department in which medical devices are reprocessed. Documentation is an important part of quality assurance. A QUALITY MANUAL must contain the following documentation:

Working instructions
Taking account of the regulations and provisions, procedural steps must be defined and explicit working instructions and job descriptions compiled. Any deviations and special remarks must be described separately, giving reasons for them.

Documentation
Expert opinions and manufacturers instructions such as technical leaflets, warranties and processing instructions must be filed separately and updated as required.

Validation, periodic tests, routine tests and technical maintenance
Technical and hygiene tests as well as routine checks must be specified and documented in the CSSD. Any corrections made after obtaining the results must be documented and explained. These documents serve as proof that the specified procedural steps and processes are being complied with in a reproducible manner and checked at regular intervals.

Staff training and briefing
Written records must be kept and filed of staff training courses and briefing, giving the course content, participants and course leader

A chain is only as strong as its weakest link. Therefore for any quality assurance concept it must be borne in mind that quality is possible only in a team and that coordinated interaction is also needed with other departments.