The use-by date determines how long a sterilized pouch remains considered sterile. Its calculation depends on the packaging type, storage conditions, and handling. Ordinul MS 1761/2021 requires date and batch number on every package.
The use-by date (DLU) 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 use-by date 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, in accordance with the EN 868 standard. Any pouch that 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.
Under Ordinul MS nr. 854/2022, labeling has been simplified: each pouch must bear the sterilization date and the batch number. Practices with more detailed traceability systems are encouraged to also include the use-by date (DLU), the autoclave cycle number, 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 use-by date must be reprocessed: opening, cleaning, repackaging, and a new sterilization cycle. It must never be used. The temptation to extend the use-by date without reprocessing is a documented failure point during DSP (Directia de Sanatate Publica — Public Health Directorate) inspections.
For detailed information on autoclave biological controls, see the dedicated guide.
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