The use-by date (DLU) determines how long a sterilized pouch remains considered sterile. Its calculation depends on the packaging type, storage conditions, and handling.
The DLU (date limite d'utilisation, or use-by date) is the date beyond which a sterilized medical device can no longer be considered sterile, even if the packaging appears intact. It must be marked on each pouch at the time of packaging, before the autoclave cycle.
The DLU does not depend solely on the sterilization process: it depends primarily on the integrity of the packaging and the storage conditions.
Single-layer peel pouch (paper/plastic): 2 months under optimal storage conditions. Double-wrapped peel pouch: up to 6 months. Rigid sterilization container with filter: up to 6 months (check manufacturer's recommendations).
These durations are indicative and assume optimal storage. Any pouch that is punctured, wet, stained, or opened must be considered non-sterile, regardless of the DLU.
Sterilized pouches must be stored in a clean, dry, enclosed space, away from direct light and dust. Temperature should be stable (between 18°C and 25°C) with relative humidity below 60%.
Pouches must not be stacked under excessive weight, compressed in an overfull drawer, or handled with unsanitized hands.
Each pouch must bear: the sterilization date, the DLU, the autoclave cycle number (for traceability), and the content identification (instrument or lot). This information links the pouch to the autoclave cycle that processed it, completing the traceability chain.
A pouch past its DLU must be reprocessed: opening, cleaning, repackaging, and a new sterilization cycle. It must never be used. The temptation to extend the DLU without reprocessing is a documented failure point during ARS and ONPP inspections.
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