Sterilization Guidelines

Reusable instruments:

Sharp instruments; Suture instruments; General surgery instruments; Orthopedic and trauma surgery instruments; Microsurgical instruments; ENT (Otolaryngological) instruments; Dental / Odontostomatological instruments; Ophthalmic instruments; Diagnostic devices; Devices for sterilization and packaging.

Instruments must be handled with due care and in accordance with the manufacturer's recommendations set forth in these instructions. Please note that only clean, disinfected, and thoroughly dried instruments can be effectively sterilized.

Before each use, the instruments must be inspected for overall quality and technical condition – including component wear and potential mechanical damage. The instrument must be fully functional, free of post-procedure biological residues, free of deposits from cleaning, disinfection, and sterilization processes, and free of structural material defects. Detailed inspection instructions can be found in the "Warnings and Contraindications" section.

Instruments are delivered non-sterile. They are reusable instruments intended for surgical and clinical procedures. Instruments must be cleaned and reprocessed both prior to first use and immediately after each clinical procedure.

Gross soiling should not be allowed to dry on instruments; severe biological residues must be removed immediately.

It is recommended that contaminated instruments be transported in sealed, rigid containers.

During transport, protect instruments against damage and moisture, and ensure instrument traceability.

Pre-treatment should take place immediately after clinical use.

Immediately after use, immerse instruments in an aqueous disinfectant and cleaning solution formulated for reusable medical instruments (e.g., Dürr Dental ID212 Forte). The solution concentration and soaking time must comply with the disinfectant manufacturer’s instructions; however, the soaking time should not exceed 1 hour to prevent surface damage. Organic residues must not be allowed to dry; gross soil must be removed immediately after use. Cannulated instruments must be flushed and cleared with a guide wire/stylet after the procedure to remove debris from the lumen. If accumulated residues cannot be removed from the cannula, the device has reached the end of its service life and must be disposed of.

Instruments should undergo pre-treatment immediately upon removal from the immersion bath. Leaving used instruments soiled with blood or bodily fluids can lead to corrosion and pitting, prevent effective cleaning and sterilization, and result in cross-contamination.

Equipment used: nylon brush, running water at 20 ± 2°C of at least potable water quality.

1. Rinse instruments under running water for 60 seconds and brush thoroughly with a nylon brush, paying special attention to hard-to-reach areas: crevices, serrations, box locks, hinges, threads, cannulae, lumens, holes, and recesses. Use soft nylon brushes, including appropriately sized lumen/channel cleaning brushes (never use metal wire brushes).
2. Rinse instruments thoroughly under warm running water, ensuring all crevices and internal lumens are flushed completely.
3. Visual inspection – pre-cleaning must remove all gross biological residues; instruments must be free from visible stains and streaks. If contamination remains, repeat the pre-cleaning process.

Depending on the available equipment, proceed with manual or automated cleaning and terminal disinfection as described below.

Equipment used:

- disinfection bath / basin,
- ultrasonic cleaner,
- cleaning and disinfecting agent approved for reusable medical instruments (e.g., Dürr Dental ID212 Forte) or another certified medical device detergent/disinfectant,
- warm demineralized/treated water at a temperature not exceeding 42°C.

1. Prepare the solution according to the manufacturer's instructions (e.g., Dürr Dental ID212 Forte, 2% working solution) and fill the disinfection basin or ultrasonic bath.
2. Fully immerse the instruments into the solution, ensuring no air bubbles remain inside lumens or crevices.
3. When using a soaking bath, clean the instruments manually with a nylon brush. Leave instruments submerged for the duration specified by the chemical and device manufacturers, but for at least 5 minutes in a static bath or at least 1 minute in an ultrasonic cleaner.
4. Remove instruments from the bath and rinse thoroughly with demineralized water for at least 30 seconds.
5. Inspect cleanliness. If residual contamination remains, repeat the above steps. If instruments are clean, dry them thoroughly using a single-use, lint-free wipe, and allow residual moisture in recesses and joints to evaporate prior to packaging.

Equipment used:

- washer-disinfector validated in accordance with the EN ISO 15883 standard series,
- cleaning agents and disinfectants approved for reusable medical instruments in washer-disinfectors, preferably formulated with corrosion inhibitors.
Always follow the instructions for use provided by the chemical manufacturers.
- demineralized water.

Procedure

Load instruments into a suitable tray or load carrier so that all surfaces are accessible to spray jets and cleaning solutions. Instruments with long lumens or cannulae (e.g., applicators) should be connected to irrigation rails or manifolds that flush pressurized water through the channel. Secure small instrument parts in covered wire mesh baskets.

1. Close the washer-disinfector and run the cycle recommended by the equipment manufacturer and the detergent/disinfectant manufacturer.
2. Unload instruments immediately upon program completion.
3. Visually inspect the cleanliness of the instruments upon removal. If any residual soil is detected, re-clean the instruments manually and repeat the automated cleaning and disinfection cycle.

The automated cleaning, disinfection, and drying stages in the washer-disinfector must comply with the PN-EN ISO 15883 standard series.

Following cleaning, disinfection, and drying, visually inspect all instruments. Examine instruments for cleanliness, structural integrity, and smooth function, using an illuminated magnifier if necessary. If any contamination is observed, repeat the cleaning and disinfection cycle. Additionally, inspect all instruments for mechanical damage, wear, or distortion. Cutting edges must be free of nicks and sharp across their entire length. Verify proper assembly. Confirm that devices retain full operational function; damaged, corroded, or deformed instruments must not be reused and must be segregated immediately.

After cleaning and disinfection, and prior to autoclave sterilization, lubricate all articulated and moving parts. Use a medical-grade instrument lubricant suitable for steam sterilization (e.g., STERILIT® I oil), applying it evenly to the joint surfaces without allowing oil to run over non-moving parts. Remove excess lubricant with a sterile gauze pad.

Only use maintenance lubricants that are vapor-permeable and validated for steam sterilization processes.

Materials and equipment used:

- paper-film pouches / sterilization packaging intended for steam sterilization compliant with the EN ISO 11607 standard series,
- heat-sealing device for paper-film packaging.

Packaging must be carried out in an area with controlled particulate and microbiological quality. Ensure that pouches/wraps are adequately sized so that instruments do not place mechanical tension on the seal seams. Protect instruments with sharp cutting edges or fine tips to prevent puncture of the packaging barrier. Place an appropriate chemical indicator / sterility assurance integrator inside the packaging.

Instruments should be sterilized in sterilization trays placed inside a rigid sterilization container or wrapped appropriately.

Equipment used: Large steam sterilizer compliant with EN 285:2015+A1:2021 or small steam sterilizer compliant with EN 13060:2014+A1:2018 (Type B cycle) – validated according to applicable standards (EN ISO 17665-1:2006, EN ISO 14937:2009) and established facility procedures.

Moist heat (steam) sterilization is recommended at 134°C for a minimum holding time of 5 minutes, with a minimum drying time of 20 minutes. When sterilizing multiple devices in one cycle, ensure that the maximum load capacity of the sterilizer is not exceeded. To prevent mechanical damage during sterilization, individual instruments must be kept separated from one another.

1. Place the packaged product into the sterilization chamber.
2. Run the validated sterilization cycle.
3. Upon program completion, remove the sterile load and allow it to cool down to room temperature.
4. Inspect the sterile packaging for seal integrity, residual moisture, or package damage. Compromised or moist packaging must be deemed unsterile; in such cases, instruments must undergo the full cleaning, disinfection, and sterilization cycle again.

Instruments may undergo cleaning, disinfection, and sterilization cycles between 200 and 500 times, depending on the instrument type and design. The manufacturer considers this cycle range safe for the devices; however, the actual lifespan depends on the degree of wear – see the "Warnings and Contraindications" section below. The user bears responsibility for monitoring the number of sterilization cycles and retirement of worn instruments.

Sterilized instruments must be stored in clean, dry, dust-free conditions protected from mechanical damage and recontamination, in compliance with internal facility protocols and relevant national standards.

Transporting sterile instruments to the point of use must take place in closed, rigid transfer containers to prevent physical damage, exposure to moisture, or breach of sterility barrier. Instrument traceability must be maintained.

Although corrosion-resistant medical alloys are selected during manufacturing, the service life and number of reprocessing cycles depend heavily on external factors, including the proper execution of cleaning, disinfection, drying, steam sterilization, routine lubrication, and proper clinical handling.

The instruments do not have a defined expiration date. Their operational service life is determined by wear and tear resulting from routine clinical use.

Before each use, test the instrument to confirm correct mechanical operation. Check all moving components (e.g., hinges, joints, ratchets, box locks) for full and smooth mobility. Visible damage, stress fractures, surface degradation, deformed working ends, or dull cutting blades indicate that the instrument must be removed from service immediately.

The instructions provided above have been validated as capable of preparing reusable medical instruments for clinical re-use.

Proper handling and care in accordance with the intended purpose significantly extends the functional service life of the instruments.