The use-by date determines how long a sterilized pouch remains considered sterile. The KRINKO/BfArM Recommendation and DIN 58953 define the requirements for packaging, labeling, and storage. Every batch must be marked with sterilization date, batch number, and use-by date.
The use-by date (Verfallsdatum) 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. German regulations -- the KRINKO/BfArM recommendation and the Medical Devices Operator Ordinance (MPBetreibV) -- require this labeling for all sterilized instruments.
The use-by date does not depend solely on the sterilization process: it depends primarily on packaging integrity and storage conditions. A perfectly executed autoclave cycle is meaningless if the pouch is later compromised by handling, humidity, or physical damage. DIN EN 868 defines the packaging standards that determine shelf life.
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 follow the general guidelines accepted across German professional associations and align with DIN EN 868 packaging standards.
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 marked use-by date. The event-related shelf life concept applies: sterility is maintained as long as packaging integrity is preserved, up to the maximum indicated duration.
Sterilized pouches must be stored in a clean, dry, enclosed space, away from direct light and dust. Temperature should be stable (between 18 degrees C and 25 degrees C) with relative humidity below 60%. Pouches must not be stacked under excessive weight, compressed in an overfull drawer, or handled with unsanitized hands.
First-in, first-out (FIFO) stock rotation ensures the oldest pouches are used first, minimizing waste from expired sterility. SecuSteri calculates the use-by date for each pouch automatically based on the sterilization date and the configured packaging type, generating labels with the date clearly visible.
Each pouch must display: the sterilization date, the use-by date (Verfallsdatum), the autoclave batch number (Chargennummer) 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. Inspectors from the Gesundheitsamt (local public health authority) check that labels are present, legible, and consistent with the sterilization register.
Traceability software can automate this labeling process: SecuSteri generates labels with QR codes that link each pouch directly to its autoclave cycle report, eliminating handwriting errors and ensuring every required field is present.
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 on a patient. The presence of expired pouches in active storage is one of the most frequently cited findings during Gesundheitsamt inspections. Violations can be penalized under Section 73 of the Infection Protection Act (IfSG) with fines of up to 25,000 euros.
For detailed information on autoclave biological controls, see the dedicated guide.
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