RKI Labelling After Sterilization

The labelling of sterilized instruments enables complete traceability of sterilized goods – from the batch to the patient. For critical instruments, it is required by law.

1Which instruments must be labelled?

Primarily critical instruments that come into contact with sterile body areas. Traceability is essential here to minimize the risk of infection and to meet legal requirements.

2Mandatory information on the packaging

· Sterilization date
· Unique batch identification (sterilization batch / cycle number) for traceability to the batch
· if applicable, expiry date – as well as, if shorter, the sterile shelf life (depending on packaging, transport and storage conditions)
· documented release decision with assignment to the releasing person (batch documentation)

This ensures that the sterilization packaging can be used at any time to verify when and under what conditions the instrument was sterilized.

3Labelling methods

1. Label printer (e.g. SteriTrace). Such a label printer produces self-adhesive labels with all required information and a barcode – efficient and with minimal errors. SteriTrace covers the entire documentation cycle even without a connection to practice management software.

2. Via practice management software. Networked premium autoclaves from Steri24 can be connected via Wi-Fi/LAN to practice management software; labels are generated directly from the documentation. (Hygiene management modules in the practice software may incur additional costs.)

3. Manually by pen. Without a printer, writing is done exclusively on the film side (never on the permeable paper side) and outside the seal seam – using a suitable, solvent-free/low-migration sterilization marker.

Important additional points per RKI & standards

These points are frequently overlooked in practice but are essential for correct and legally compliant implementation:

• Timing of labelling / batch assignment only after release: It should be clarified that the final batch identification is only applied after a successful, documented batch release (comparison of process parameters with the validation report, inspection of packaging and indicators). The batch number is uniquely assigned to the respective load.Source: KRINKO/BfArM 2012, Sections 2.2.7 (documented release) and 2.2.8 (batch documentation); Steri24 FAQ (labelling always after sterilization)
• Product designation must be identifiable: For the user, the usage-relevant designation of the medical device must be identifiable where not immediately apparent (e.g. model/size, set/tray name, contents). For trays/sets, this is achieved via a unique set identifier in conjunction with an illustrated tray list/standard load configuration.Source: KRINKO/BfArM 2012, Section 2.2.6 ("designation of the medical device that permits usage-relevant identification")
• Evidence of a completed process (process indicator): The packaging must show the user that the pack has actually undergone the sterilization process. This is typically achieved via a process indicator (indicator dot on the sterilization packaging or indicator tape) that distinguishes sterilized from unsterilized packs.Source: KRINKO/BfArM 2012, Section 2.2.6 (process indicators; "the completed process must be identifiable for the user")
• Traceability level by risk class: For critical-A and critical-B medical devices, traceability must be ensured at least to the respective batch; for critical C, traceability to the individual reprocessed product is required (more rigorous labelling/documentation).Source: KRINKO/BfArM 2012, Section 2.2.6 (critical A/B = batch, critical C = reprocessed product)
• Retention period for documentation: The batch/release documentation linked to the labelling must be retained for at least 5 years; further retention periods (e.g. patient documentation) remain unaffected. This tamper-proof archiving is handled by the free ClavioSoft entirely without paper folders.Source: KRINKO/BfArM 2012, Section 2.2.8 ("to be retained for at least 5 years"); MPBetreibV Section 8
• Assignment of batch to patient (application documentation): Complete traceability "to the patient" should be described in concrete terms: When critical medical devices are used, the batch is assigned to the patient (e.g. via a second, removable label placed in the patient record or the surgical protocol) so that all affected applications can be identified in the event of damage or recall. This batch-to-patient assignment can be documented quickly and traceably with the free ClavioSoft.Source: KRINKO/BfArM 2012 (traceability); MPBetreibV Section 8 (documentation); Steri24 FAQ (removable tracing labels for the patient record)
• Legibility/durability of labelling throughout the shelf life: The labelling must remain legible throughout the entire shelf life. Store thermal labels/thermal paper in a dry location, protected from heat and light, as legibility may otherwise deteriorate; for removable documentation labels, the second label is transferred to the patient record.Source: Steri24 FAQ (thermal paper/label durability, removable tracing labels); KRINKO/BfArM 2012, Section 2.2.6 (labelling must be identifiable/legible for the user)

Required equipment, consumables & accessories

Checklist for this step – items you should have ready (shopping list):

References

1. KRINKO/BfArM 2012, Bundesgesundheitsbl. 55:1244–1310 – Section 2.2.6.
2. MPBetreibV § 8 (traceability, documentation).