RKI Hygiene Room per KRINKO

The reprocessing room is the centrepiece of instrument reprocessing. KRINKO requires a spatial-functional separation of reprocessing into the areas/zones unclean, clean and storage, with non-crossing material and personnel flow. The term black-and-white principle, commonly used in practice, does not appear in the KRINKO text itself.

1Unclean and Clean Area

Unclean area – for receiving, cleaning, disinfection and pre-treatment of contaminated instruments:

· Stations for manual cleaning/disinfection · Washer-disinfectors (WD) · Ultrasonic cleaners.

Clean area – for visual inspection, care, packaging and sterilisation:

· Autoclaves · Workstations for visual inspection and packaging. Only clean, disinfected instruments may be processed here.

Storage – a dedicated zone for recontamination-protected storage of packaged sterile goods:

· Cabinets for sterile goods. According to KRINKO (Annex 5), storage must be maintained as a separate zone and is not to be counted as part of the clean area.

2Spatial or Temporal Separation

The required degree of separation depends on the category of the reprocessing unit: Category A (semi-critical A / critical A) permits a zone separation of unclean – clean – storage, where temporal separation is possible; Category B (semi-critical B / critical B) requires a spatial area separation into unclean – clean – storage; Category C requires dedicated rooms for each. Temporal separation alone therefore only suffices for Category A. The decisive factor is always that contaminated and sterile instruments must not come into contact.

3Workflows & Hygiene Requirements

· Non-crossing paths: contaminated and sterile instruments must not cross; areas must be clearly marked.
· Surfaces: smooth, joint-sealed and designed so that they can be easily cleaned and wipe-disinfected and are resistant to the (listed) surface disinfectants used. The KRINKO recommendation does not specify particular materials; it refers to the recommendation on surface cleaning and disinfection.
· Hygiene plan: regular cleaning/disinfection of all work areas according to a defined plan.

Important Additional Points per RKI & Standards

These points are frequently overlooked in practice but are essential for correct, legally compliant implementation – and are precisely the aspects checked during a practice inspection:

• Recontamination-protected storage and sterile-goods labelling: Packaged sterile goods must be stored in the storage zone in a dust-protected, clean, dry environment at room temperature to prevent recontamination (e.g. in closed cabinets/drawers). The packaging must be labelled (including sterilisation date, batch identification and, where applicable, expiry date and sterile-goods shelf life if shorter than the expiry date). The storage period depends on packaging, seal integrity and storage conditions.Source: KRINKO/BfArM 2012, Sect. 2.2.6 (Labelling) and Sect. 3 (Transport and Storage)
• Qualified personnel: Reprocessing may only be carried out by personnel with documented specialist knowledge. This includes instrument science, knowledge of hygiene/microbiology including transmission routes, as well as risk assessment and classification of medical devices and the procedures used. Specialist knowledge requirements are described in Annex 6 of the KRINKO/BfArM recommendation (in conjunction with MPBetreibV).Source: KRINKO/BfArM 2012, Annex 6 (Specialist Knowledge of Personnel); MPBetreibV
• Validated processes and batch documentation: Validated processes must be used throughout reprocessing; the recorded process parameters and the release decision must be documented with reference to the releasing person and the batch (batch documentation). Records must be retained for at least 5 years and may also be kept on data carriers; digital documentation software facilitates traceable recording and release – for example the free ClavioSoft, which lets you complete batch and release documentation in just a few clicks and store it in an audit-proof manner.Source: KRINKO/BfArM 2012, Sect. 2.2.8 (Batch Documentation); MPBetreibV
• Non-crossing material flow and drying before transfer to the clean area: Material flow must be consistently unidirectional (unclean -> clean -> storage) without return paths. Reprocessing includes cleaning, optional intermediate rinsing, disinfection, rinsing and drying; complete drying is a prerequisite for packaging and sterilisation. The reprocessing instructions provided by the manufacturer (per DIN EN ISO 17664) must be followed. Contaminated instruments must be transported in safely enclosed (closed transport containers) to the reprocessing location.Source: KRINKO/BfArM 2012, Sect. 1.2 and Annex 5 (Spatial-Functional Separation) and Sect. 2.2.1/2.2.2 (Preparation, Cleaning/Drying)
• When a separate room is not mandatory (Category A): A dedicated reprocessing room is not mandatory in every case: for simple Category A reprocessing, the process may take place in a single room divided into the zones unclean - clean - storage, provided workflows (including temporal ones) are properly separated and paths are non-crossing. For Categories B and C, this is not sufficient.Source: KRINKO/BfArM 2012, Annex 5 (Category A: Zone Separation, Temporal Separation Possible; Footnote 5: A Room May Be Divided into Areas and Zones)

Required Equipment, Consumables & Accessories

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

References

1. KRINKO/BfArM 2012, Bundesgesundheitsbl. 55:1244–1310 – Sect. 1.2/2.2; Annex 5 (AEMP).
2. MPBetreibV § 8.