RKI Instrument Maintenance

Maintenance follows directly after cleaning and drying and is carried out before packaging. It keeps moving parts functional, protects against corrosion and prepares the instruments for sterilisation – particularly important for turbines as well as handpieces and contra-angle handpieces.

1Purpose of maintenance

Regular maintenance prevents wear, corrosion and malfunctions and significantly extends the service life of instruments. Transmission instruments with moving parts must be maintained or lubricated as required in accordance with the instrument manufacturer's instructions. Use lubricants only in the required quantity, as they can impair the success of sterilisation.

2Procedure – step by step

1. Instruments must be completely cleaned, dry and residue-free.
2. Apply medically approved maintenance oil evenly into all openings and joints (spray system or automatic maintenance device).
3. Remove excess oil with a lint-free cloth.
4. Briefly run the instrument to distribute the oil evenly.
5. Reassemble the instrument and check for correct function as well as cleanliness and integrity (technical-functional inspection per KRINKO 2.2.3). Only release instruments in perfect condition; document defects and rectify them or discard the instrument.
6. Only then package and sterilise – this ensures the maintained instrument becomes flawless sterile goods.

Equipment & aids

· Automatic maintenance devices for turbines, handpieces and contra-angle handpieces
· Maintenance spray with suitable adaptors
· Compressed-air connection for blow-drying
· Lint-free cloths

Important additional points per RKI & standards

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

• Functional inspection / functional check before packaging: Before packaging, instruments must be reassembled and checked for correct function as well as cleanliness and integrity (e.g. joints, locks, running of transmission instruments). This technical-functional inspection must be carried out per KRINKO 2.2.3 after cleaning/drying but before sterilisation; identified defects must be documented, their cause investigated and rectified, otherwise the instrument must be discarded. You can record such defect reports and the associated batch documentation quickly and traceably using the free ClavioSoft.Source: KRINKO/BfArM 2012, Section 2.2.3 and Section 6; MPBetreibV
• Standard operating procedure (SOP) and documentation: The type and scope of maintenance and technical-functional inspection must be defined product-specifically in a written standard operating procedure; identified defects must be documented, their cause investigated and rectified. This is part of the QM-supported reprocessing workflow and requires appropriate expertise on the part of the reprocessing personnel. You can create and manage SOPs and the associated documentation easily with the free ClavioSoft.Source: KRINKO/BfArM 2012, Section 2.2.3 ('Umfang und Art der Prüfungen ... sollen in der Standardarbeitsanweisung definiert sein (QM)'); MPBetreibV
• Internal lubrication of transmission instruments via suitable adaptors: For transmission instruments (handpieces and contra-angle handpieces, turbines), the maintenance sequence specified by the manufacturer must be followed: introduce lubricant into the channels via the appropriate adaptor, briefly run the instrument, and remove excess oil with a lint-free cloth. Without an adaptor matching the connection standard, manufacturer-compliant internal maintenance is not possible.Source: DIN EN ISO 17664 (manufacturer's instructions for reprocessing); KRINKO/BfArM 2012, Section 2.2.3 (maintenance per manufacturer's instructions)
• Complete drying as a prerequisite before lubrication: Before applying maintenance oil, the instruments and especially the internal channels must be completely dry and residue-free (blow out with compressed air if necessary). Residual moisture can reduce the effectiveness of the lubricant.Source: KRINKO/BfArM 2012, Section 2.2.2 (rinsing and drying) and Appendix 2 (blow-dry tubing and channels with compressed air); DIN EN ISO 17664
• Machine-based vs. manual maintenance (reproducibility): Where possible, machine-based, metered maintenance in a maintenance device is preferable to manual spray lubrication, as it applies reproducible oil quantities and is more easily standardised and validated. With manual spray lubrication, ensure metered quantities and remove any excess.Source: KRINKO/BfArM 2012, Section 2.2.2 (preference for standardisable, reproducible machine-based procedures); DIN EN ISO 17664
• Occupational safety during maintenance: When applying maintenance oils/sprays, avoid aerosol formation and skin contact; wear suitable personal protective equipment (gloves, safety goggles if applicable) and ensure adequate ventilation. There must be no contamination with substances harmful to health that persist through subsequent reprocessing steps.Source: KRINKO/BfArM 2012, Section 2.2.3 (no contamination with substances harmful to health) and Section 2.2.2 (protective clothing, safety goggles, gloves; TRBA 250)

Required equipment, consumables & accessories

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

Sources

1. KRINKO/BfArM 2012, Bundesgesundheitsbl. 55:1244–1310 – Section 2.2.2/2.2.3.
2. DIN EN ISO 17664 (manufacturer's instructions for reprocessing); MPBetreibV § 8.