European Forum for Hospital Sterile Supply |
EFHSS Education
Recommendations by the Quality Task Group |
Recommendations | AK "Qualität" | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
with kind permission of mhp-Verlag GmbH |
|||||||||||||||||||
[15] Release and Storage of Medical Devices after SterilisationOn completion of the steam sterilisation procedure, the medical devices must be released for use or storage. Based on Section 4 of the Medical Devices Operator Ordinance (MPBetreibV), medical devices must be processed using suitable validated procedures. In accordance with DIN 58946 Part 6.4.4 and Part 7.5, the devices must be released by authorised EXPERIENCED PERSONNEL. Compliance with this standard can be assured by means of documented briefing of personnel and formulation of working instructions for release of sterile items. The minimum requirements for release of medical devices after steam sterilisation are outlined in DIN 58946 Part 6.4.4 "Release of sterile items" and include:
The RELEASE OF STERILE ITEMS must be documented. Likewise, based on suitable measures it must be possible to reliably differentiate between released and non-released sterile items. It is permitted to release certain items of a batch and withhold others while documenting the reason. The requirements enshrined in the standard represent the minimum requirements. However, in practice additional measures may be needed, e.g. use of chemical batch control measures and simulation process challenge devices (PCDs). Since no one can predict with absolute certainty just how an indicator used in 2001 will be after a few years, whether possible changes in colour will appear, it is necessary to document the results. The type of documentation must be stipulated in corresponding working instructions. The indicators used (e.g. Bowie & Dick test, chemical indicators etc.) can be discarded after documentation. Storage of Sterile Items SPECIFICATION OF THE STORAGE TIMES within the hospital is the responsibility of the medical director and can be decided in the infection control commission. If different storage conditions apply for different departments, the respective storage periods must be documented in writing.
In order to be able to specify the SAME STORAGE TIMES within a hospital, the storage conditions in the various departments must be kept as uniform as possible. In daily hospital practice, it can be beneficial to give the expiry date on the sterile items’ packaging so that the user can easier see whether the article may still be used. To avoid frequent resterilisation, and thus reduce costs, it is advisable to optimise storage conditions so as to be able to avail of the maximum storage time if needed. |
ONLY EXPERIENCED PERSONNEL may release sterilised medical devices Requirements for release: CORRECT PROCESS SEQUENCE VISUAL INSPECTION CORRECT LABELLING OF STERILE ITEM IF APPLICABLE, COMPLETE CHANGE OF COLOUR OF PROCESS INDICATORS BATCH DOCUMENTATION RELEASE OF STERILE ITEMS must be documented. This is absolutely necessary to prove that a sterilisation process has been properly conducted. THE DURATION OF STORAGE depends on the storage conditions. SPECIFICATION OF STORAGE TIMES is done in the infection control commission. The storage periods should be set down in writing. TIP FOR THE PRACTICE: SAME STORAGE TIMES in different departments require the same storage conditions. Adaptation of these conditions can permit a longer duration of storage. |
European Forum for Hospital Sterile Supply |
Developed by Baumeister Mediasoft Engineering