Instrument Care & Reprocessing
Comprehensive reprocessing instructions for all reusable dental and surgical instruments manufactured and distributed by ErgoDenta ApS.
ED-RPR-001 (Rev 00)Perform the following immediately after use and within a maximum of two hours of application, before transferring instruments to the CSSD/sterilization unit:
- Remove gross contamination with a moist cloth or cotton swab moistened with isopropyl alcohol (70%) or ethyl alcohol and gently wipe the surface of the product.
- Prevent contaminants from drying on instrument surfaces. Keep instruments moist until transferred for cleaning.
- For manual removal of coarse contamination, use only a soft brush or long-handled soft brush. Do not use metal brushes or steel wool, as these will damage instrument surfaces.
- Open all hinged instruments (forceps, scissors, needle holders) fully.
- ErgoTip modular instruments (handle + working tip) are processed as assembled units. Disassembly is not required before cleaning.
- Transport instruments to the cleaning area in a covered, puncture-resistant container.
Special Care for Mouth Mirrors and Handles
- Always clean the Mouth Mirror and Handle in disassembled form (separated from each other).
- Always wipe the mirror surface from side to side rather than in a circular motion.
- Use a soft brush for cleaning the instrument if required. Avoid using brush for cleaning the mirrors.
Equipment: Use an automated washer-disinfector suitable for surgical/dental instruments, such as a Miele G 7836 CD or equivalent conforming to EN ISO 15883.
Cleaning detergent: Use Neodisher MediZym (Dr. Weigert, Hamburg) at 1% concentration, or equivalent enzymatic cleaning detergent with neutral pH (approx. pH 6.5–8.5).
| Parameter | Value |
|---|---|
| Detergent concentration | 1% |
| Cleaning temperature / hold time | 50°C / 10 minutes |
| Thermal disinfection | 93°C / minimum 5 minutes |
| Drying | 110°C / 25 minutes |
Loading Instructions
- Position instruments in appropriate baskets or cassettes ensuring all surfaces are fully exposed to the cleaning solution and water jets.
- Ensure there is no contact between instruments during loading to prevent mechanical damage.
- Place all hinged instruments in the fully open / unlocked position.
- Always follow the washer-disinfector manufacturer’s loading instructions.
- After the cycle: visually inspect each instrument for residual contamination. If visible, repeat the cleaning cycle.
When selecting and using a washer-disinfector, ensure:
- The washer-disinfector has approved efficiency and is regularly maintained and calibrated per manufacturer’s instructions.
- The program is suitable for surgical/dental instruments and includes sufficient rinsing steps.
- Post-rinse uses low-contamination, deionized or purified water (max 10 germs/ml, max 0.25 endotoxin units/ml).
- Only filtered air is used for the drying phase.
- The selected detergent is compatible with the instruments. Refer to Section 10 (Material Resistance) for incompatible substances.
Inspect all instruments under adequate lighting after cleaning and before packaging:
- Cleanliness: No visible contamination, staining, or residue on any surface including crevices and joints. If instruments are still visibly soiled after cleaning, clean again before sterilizing.
- Integrity: No cracks, deformation, corrosion, or damage. Discard any instrument showing signs of damage.
- Hinged instruments (forceps, needle holders, scissors): Ratchet and hinge mechanisms must move freely and lock/unlock correctly. Jaws and blades must align precisely and open/close smoothly.
- Modular instruments: Verify secure and correct connection between ErgoTip handle and working tips.
Surface staining may occasionally occur due to water mineral content or contact with corroded instruments from other sources. Light surface stains may be removed using an appropriate instrument care product, such as Sterilit Instrumenten-Milch, or equivalent medical-grade instrument care milk.
All instruments with a hinge, ratchet or box-joint mechanism must be lubricated with a medical grade lubricant suitable for steam sterilization, such as Sterilit Instrumenten Ölspray (300 ml) or equivalent.
Application procedure:
- Apply lubricant to the hinge/box joint and ratchet mechanism of the instrument.
- Open and close the instrument several times to distribute the lubricant evenly through the mechanism.
- Remove any excess lubricant with a clean, lint-free cloth.
Ensure instruments are completely dry before packaging.
Use STERIKING paper/film sterilization pouches (Wipak Medical) or equivalent double paper/film peel pouches in an appropriate size.
Ensure the chosen packaging fulfils:
- Suitable for steam sterilization: Temperature resistance to at least 141°C (286°F) with sufficient steam permeability.
- Protection: Adequate protection against mechanical damage during handling and storage.
- Compliance: Conforms to EN ISO 11607-1 (Packaging for terminally sterilized medical devices).
- Maintain and inspect packaging and sealing equipment regularly per manufacturer’s instructions.
Packaging Steps
- Select a pouch of appropriate size.
- Insert hinged instruments in the open/unlocked position.
- For ErgoTip modular instruments, package the assembled handle and tip as a unit.
- Heat-seal the pouch per manufacturer’s instructions. Verify seal integrity visually.
- Label the pouch with instrument name, sterilization date, expiry date, and lot/batch reference.
Use a steam sterilizer (autoclave) conforming to EN 13060 (small sterilizers) or EN 285 (large sterilizers).
Sterilization parameters – Fractionated pre-vacuum (B-class) – Recommended:
| Parameter | Value |
|---|---|
| Temperature | 134°C (273°F) |
| Hold time | Minimum 4 minutes at 134°C |
| Drying time | Minimum 30 minutes |
The sterilization equipment must be validated and maintained per EN ISO 17665 and the equipment manufacturer’s instructions.
- Immediate-use (flash) sterilization for wrapped instruments
- Gravity displacement (downward displacement) cycles
- Radiation, formaldehyde, ethylene oxide (EtO), or plasma sterilization
- Dry heat sterilization (unless the instrument’s specific IFU explicitly permits it)
Sterilizer maintenance:
- Observe the sterilizer manufacturer’s instructions for routine inspection and regular maintenance.
- Clean the sterilizer chamber on a regular basis.
- Use only low-contamination, deionized or purified water in the sterilizer.
- Sterilizers with an automatic drying program are recommended. Ensure items are completely dry after sterilization.
- Allow instruments to cool completely inside the sterilizer before handling. Do not compress pouches while warm.
- Inspect each pouch for seal integrity, tears, moisture inside the pouch, or other damage. Do not use any instrument whose packaging is compromised — reprocess before use.
- Verify that sterilization process indicators (if used) have changed to the correct state.
- For hinged instruments: check hinge and ratchet movement before storing.
- Store sterile instruments in their original sealed packaging in a clean, dry, dust-free environment protected from mechanical damage, humidity, and direct sunlight.
- Keep sterile and non-sterile instruments strictly apart. The sterilization status must be clearly indicated on all packaged items.
- Do not use beyond the maximum storage time specified by the sterilization pouch manufacturer.
- If packaging seal is broken or compromised during storage, the instrument must be reprocessed before use.
- Follow the storage temperature and humidity conditions specified by the pouch manufacturer.
Detergents or disinfectants containing any of the following substances must not be used, as they may cause corrosion, discoloration, or irreversible material damage:
ErgoDenta dental and surgical instruments contain no hazardous materials. However, all instruments must be fully decontaminated (cleaned and sterilized) before disposal. Dispose in accordance with local and national regulations for medical waste or reusable medical devices.