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Documentation System


The gke Steri-Record® Documentation system is used for patient-related traceability of all medical sterilization processes. The documentation sheet contains all necessary information to release a ster- ilization batch. For one sterilizer and day, one docu- mentation sheet is used (see page 3). Using a gke labelling device the documentation sheet and each sterile packing can be labelled with a self-adhesive label that contains the following information: pro- duction and expiry date, responsible person, content of the pack, sterilizer and batch number (see figure “recommended label content” next page). All packs in the batch and the documentation sheets have the same label content and batch number.

After opening the sterile pack in the operation room the label can be peeled off and adhered to the pa- tient and/or operation-related documentation. The content of the label allows patient related tracing back to the batch-related documentation in the ster- ilization department. In case of a nosocomial infec- tion the sterilization data is available to exclude that the infection was caused by non-sterile instruments

Labels without and with indicator for steam sterili- zation processes are available in four colours: red, green, blue and yellow. Different colours allow staff to differentiate sterile goods from different produc- tion periods, enabling a correct First In/ First Out (FIFO) storage handling system.

Product description

The gke documentation system consists of the fol- lowing components:
• Hand-labeler containing three printing lines with 12 digits each, available in the following two versions:
 The whole first line can print alphanumeric digits (D-G-A).
 The first three digits of the first line can print alphanumeric digits, the remaining ones print numbers (D-G-N).The remaining two printing lines allow produc- tion and expiry date documentation.
• Selection of self-adhesive and double self- adhesive labels with or without class 1 process indicators according to EN ISO 11140-1 for steam, ethylene oxide, formaldehyde and hydro-
gen peroxide/plasma sterilization processes. Some versions are available in four different background colours.
• Documentation sheet to adhere indicator strips from PCDs and the labels (see documentation sheet above and next pages).

Labels for the following sterilization processes:

Background information

The European Medical Device Directive (MDD) requires for reprocessing of medical devices to use appropriate validated procedures and to document the results of the validation process and routine monitoring. The quality management standard for medical devices (EN ISO 13485) and the valida- tion standards of all sterilization processes (e.g. EN ISO 14937, EN ISO 17665-1 etc.) require monitoring and documentation of all relevant sterilization process parameters. This documenta- tion is required for the production or reprocessing of all medical devices independent of where they are sterilized. For each individual load a batch number is required associated with all relevant parameters used in the sterilization process.

If a sterilizer with two doors is used and one door opens in the storage room, labels without process indicators can be used under the condition that the door opens only after the sterilizer program has checked the correct process conditions.

• Easy print of identical labels with minimum time and effort.
• Eliminates mistakes in batch numbers.
• Easy trace back system without additional effort.
• The self-adhesive label offers patient-related documentation without additional paperwork.
• Innovative product design and manufacturing process provides a cost-effective indicator.
• Easy interpretation of the results due to precise colour change.
• No need for additional process indicators using for labels with indicator.
• The expiry date can be marked using different background label colours.
• Less time wasted in the CSSD- and/or OR- department.
• The label contains a specified class 1 chemical indicator according to EN ISO 11140-1.
• Environmentally friendly, all gke chemical indicators are protected from bleeding by a polymer binder and surface coating and can be disposed with normal garbage.
• The indicator colour chemistry is a non- reversible chemical reaction. The indicator strip can be a documented proof for several years without changing back to its original colour.

Recommended label documentation

Documentation Sheet For the monitoring of sterilization processes

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