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 under French regulations.
The use-by date (DLU -- date limite d'utilisation) is the date beyond which a sterilized medical device can no longer be considered sterile, even if its packaging appears intact. It must be marked on each pouch at the time of packaging, before autoclaving.
The use-by date does not depend solely on the sterilization process: it depends primarily on packaging integrity and 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 recommendations).
These durations are indicative and assume optimal storage. Any pouch whose packaging is punctured, wet, stained, or opened must be considered non-sterile, regardless of the use-by date.
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 display: the sterilization date, the use-by date (DLU), the autoclave cycle number (for traceability), and identification of the contents (instrument or batch). This information links the pouch to the autoclave cycle that processed it, completing the traceability chain.
A pouch past its use-by date must be reprocessed: opened, cleaned, repackaged, and put through a new sterilization cycle. It must under no circumstances be used. The temptation to extend the use-by date without reprocessing is a documented non-compliance finding during ARS (Agence Régionale de Santé -- Regional Health Authority) and ONPP (Ordre National des Pédicures-Podologues -- podiatry regulatory body) inspections.
For detailed information on autoclave biological controls, see the dedicated guide.
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