Use-by date for sterilized instruments in Belgium

What is the use-by date?

The use-by date is the date beyond which a sterilised medical device can no longer be considered sterile, even if its packaging appears intact. It must be written on each pouch at the time of packaging, before the autoclave cycle.

The use-by date does not depend solely on the sterilisation process: it depends primarily on the integrity of the packaging and the storage conditions.

Indicative durations by packaging type

Single-layer peel pouch (paper/plastic): 2 months under optimal storage conditions. Double-wrapped peel pouch: up to 6 months. Rigid sterilisation container with filter: up to 6 months (check the manufacturer's 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.

Optimal storage conditions

Sterilised pouches should be stored in a clean, dry, enclosed space, protected from direct light and dust. Temperature should be stable (between 18°C and 25°C) with relative humidity below 60%.

Pouches should not be stacked under excessive weight, compressed in an overfull drawer, or handled with unsanitised hands.

Mandatory labelling

Each pouch must bear: the sterilisation date, the use-by date, 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.

What to do when the use-by date has passed

A pouch past its use-by date must be reprocessed: opened, cleaned, repackaged, and put through a new sterilisation cycle. It must not be used under any circumstances. In Belgium, using instruments past their use-by date constitutes a breach of sterilisation protocols that may be flagged during an FPS Public Health inspection.

For detailed information on autoclave biological controls, see the dedicated guide.