On 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:
- Evaluation of the process sequence
The PROCESS SEQUENCE must be checked for correct program selection and for observance of parameters that are of relevance to the process, i.e. temperature, pressure and time. These parameters must comply with the specifications recorded at the time of validation of the sterilisation process.
- Visual inspection of the sterilised items
During the VISUAL INSPECTION the integrity of the packaging is checked. Cracks, defects and moisture due to condensate residues must be ruled out. When packed in containers, a check must be conducted for correct seals.
- Checking of labelling and, if applicable, check of process indicators
The LABELLING on the packaging must comprise information on content, sterilisation date, batch number and, if applicable, other information if stipulated in the context of implementation of quality-assurance measures. If PROCESS INDICATORS are used, they must be checked for complete change of colour.
- Compilation of the batch documentation
The devices can be released only after BATCH DOCUMENTATION has been compiled. The batch documentation features clear designation of sterilised items to the respective batch as well as recording of the process-relevant parameters and name of the steriliser operator.
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
The DURATION OF STORAGE is largely dependent on the storage conditions and cannot therefore be defined as a general rule. DIN 58953 Part 7 (8/1999) gives a detailed description of the requirements for stores used for sterile items. These stipulate, inter alia, that sterile items should be stored in dry rooms with little dust (sterile items' stores) or in closed cabinets.
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.
||Duration of Storage|
|Sterile item packaging
||Type of packaging
(as per 4.3) in
DIN 58953-8 (1993-02)
(as per 4.3) in
|Paper bags as per
DIN EN 868-4 and
heat and self-sealable
pouches and tubes made
of paper and plastic
composite film as per
DIN 868-5 or other
for imminent use.
Should be avoided
as a type of storage.
not opened or
provided that no other
expiry date has been
prescribed by the manufacturer
||Recommended duration of storage for sterile medical devices (from DIN 58953-7/August 1999)
1) Prolongation of the duration of storage with this type of packaging has not proved advisable for practical and economical reasons.
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.
with kind permission of|
ONLY EXPERIENCED PERSONNEL may release sterilised medical devices
Requirements for release:
CORRECT PROCESS SEQUENCE
CORRECT LABELLING OF STERILE ITEM
IF APPLICABLE, COMPLETE CHANGE OF COLOUR OF PROCESS INDICATORS
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.