Council Directive 93/42/EEC concerning medical devices, on which the German Medical Devices Act (MPG) is based, specifies in Annex 1, Section 13 "Information supplied by the manufacturer". Section 13.1 stipulates that each medical device must be accompanied by the information "needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users". This requirement rules out FOREIGN-LANGUAGE INFORMATION (operating manuals etc.) unless this is compatible with the training and knowledge of the potential users.
With reference to cleaning, disinfection and sterilisation, further important requirements are listed in 13.6 of the aforementioned section under the letters g) to i), concerning, inter alia, processing and assembly of medical devices.
The less complex the medical device, the less complex can be the relevant information. Accordingly, as per the Medical Devices Directive DEVICES OF CLASS I AND IIA need not be accompanied by an operating manual if completely safe operation of the device is guaranteed also without such a manual. But if the device in question is a device that must be dismantled for reliable cleaning, and if the procedure is not self-explanatory or if an incorrect procedure cannot be ruled out by the design of the medical device or be immediately recognised, the device must be accompanied by written information. From this can be inferred that the majority of the medical devices processed in a CSSD are devices that cannot dispense with detailed and comprehensible WRITTEN INFORMATION.
In the case of steam sterilisers, the reasons for moist sterile supplies can in principle be classified into 3 groups:
- Technical causes in the steriliser or intrinsic steam generator
- Technical causes in the operating materials used on site
- Packing, loading or operating mistakes
Item 1. Technical causes in the steriliser or intrinsic steam generator
- changed switching points
- inadequate pumping capacity of the vacuum pump
- operating water that is too warm for the vacuum pump
- non-tight door seals, heat exchangers, steam valves, pipelines
- defective steam traps
- water pockets in the steriliser's steam pipes
- inadequate insulation of the steam pipes
- unfavourable flow velocity in the steam pipe
- unfavourable gradient in the steam pipes
- unfavourable steam inflow into the chamber
- inadequate jacket heating
- water level too high in the steam generator
By ensuring expert MAINTENANCE AND REPAIR of sterilisers, technical faults can be avoided to a large extent and fault-free functioning assured.
Item 2. Technical causes in the operating materials used on site
- entrainment of condensate in the steam
- inadequate water removal from the steam pipe
- inadequate insulation of the steam pipe
- incorrect gradient in the steam pipes
- incorrect design of the steam pipes
- incorrect dimensions of the steam pipes
By observing the requirements imposed by the steriliser manufacturer as regards provision of operating materials, shortcomings can be avoided already before installing the sterilisers. Assistance and instructions for correct operation and testing of operating materials are given in DIN EN 285 "Steam sterilisers".
Item 3. Packing, loading or operating mistakes
- weight of instrument trays too heavy
- unfavourable arrangement and placement of the instruments on the trays on packing (e.g. collection of condensate in small pots, kidney bowels and similar receptacles as well as drainage impeded by positioning with the opening facing upwards)
- incorrect loading of the steriliser (e.g. "heavy" trays on top)
- incorrect programme selected
- sterile supplies placed while damp in the chamber
The OPERATING INSTRUCTIONS of the sterilisers' manufacturers give information for correct loading and operation of the systems; this information on the sterile supplies contains tips for processing and safe sterilisation of these medical devices. In the event of queries about individual devices, one should definitely contact the MEDICAL DEVICES CONSULTANT of the respective manufacturer. Furthermore, operating and loading mistakes can be avoided by ensuring that staff have a solid basic education and are given ongoing training.
1 Since there is not enough space here to describe the procedure for elimination of each possible cause, the Validation Quality Task Group limits itself to outlining individual causes so that based on this list experts can identify the actual problem and eliminate it, if necessary with the assistance of the manufacturer of the sterile items, steriliser or of the steam generation system and steam pipes.
|with kind permission of
Must we be contented with no or with foreign-language operating manuals?
FOREIGN-LANGUAGE INFORMATION is ruled out unless this is compatible with the training and knowledge of the potential users.
CLASS I AND IIA devices of these classes need no operating manual if their safe use is guaranteed also without such a manual.
WRITTEN INFORMATION must be detailed and comprehensible.
What can be the reasons for moist sterile supplies?1
MAINTENANCE AND REPAIR of sterilisers prevent technical faults and ensure fault-free functioning.
DIN EN 285 lists assistance and instructions for operating and testing operating materials.
THE OPERATING INSTRUCTIONS of the manufacturer contain information on correct loading.
THE MEDICAL DEVICES CONSULTANT of the manufacturer can answer queries on individual devices.