STERILIZATION, CARE & MAINTENANCE INSTRUCTION

Why Sterilization is essential for surgical instruments

Sterilization is crucial for surgical instruments because it helps to prevent the spread of infections and diseases between patients. During a surgical procedure, surgical instruments come into contact with bodily fluids, tissues, and other materials that may harbor microorganisms, including bacteria, viruses, and fungi. If these microorganisms are not correctly eliminated from the instruments, they can be transmitted to the next patient, potentially causing severe infections and complications.

Another Definition: Sterilization is the process of cleaning/eliminating all microorganisms from an equipment, including bacteria, viruses, and fungi, as well as their spores. Several Sterilization methods include autoclaving, ethylene oxide gas sterilization, and radiation sterilization. Each process has its advantages and disadvantages, and the appropriate method of Sterilization depends on the type of instruments and its intended use.

Proper Sterilization of surgical instruments is critical to ensure the safety and well-being of patients. In addition to preventing the transmission of infections and diseases, Sterilization can also extend the life of surgical instruments by preventing corrosion and other types of damage that can occur when instruments are not properly cleaner and sterilized.

Regulations:

• These instructions offer general guidelines, in addition to these please observe national regulations and standards.
• For patients with CJD, HIV, Hepatitis, or any other contagious diseases, observe the relevant national regulations concerning the reprocessing of the products.
• Always follow the instructions of the cleaning agent, disinfectant, and equipment manufacturer’.
• The operator is solely responsible for the success of the selected procedure and the validation of its effectiveness.

Warnings:

• Follow instructions and warnings as issued by the manufacturers of any decontaminants, disinfectants, and cleaning agents. Wherever possible avoid the use of mineral acids and harsh, abrasive agents.
• No part of the process shall exceed 140°C.
• Some sensitive materials (e.g., Aluminium) are damaged by high alkaline solutions (pH>10).
• Devices with long, narrow cannulas, hinges, and blind holes require particular attention during cleaning.

Reprocessing Limitations:

• Repeated processing can have minimal effect on instruments, end of instrument life is normally determined by wear and damage in use.
•  Any specific limitations on the number of reprocessing cycles shall be made available with the instrument.

Preparation for decontamination:

Reprocess all instruments as soon as it is reasonably practical following use. Disassemble only where intended. without the use of tools unless specifically provided by the manufacturer. Where instructions for disassembly are required, these are available with the device.

Cleaning:

 1.1 Ultrasonic Cleaning

• Use only validated and CE-marked equipment. Always follow the manufacturer’s instructions for use.
• Do not over-clean maximum immersion time of 10 minutes is recommended.
• Avoid over-crowding of instruments. Place heavier instruments at the bottom of the basket.
• Handle ‘sharps (scissors, knives, chisels, etc.) separately.
• Keep joints open and ratchets unlocked.
• Rinse instruments with water to remove the cleaning solution.

 1.2 Automatic Washer/Disinfector

• Use only CE-marked and validated washer-disinfector machines and low-foaming non-ionizing cleaning agents and detergents following the manufacturer’s instructions for use, warnings, concentrations, and recommended cycles
• Load instruments carefully, with any box joints and hinges open and so that any fenestrations in instruments can drain.
• Place heavy instruments with care at the bottom of containers, taking care, not to overload wash baskets.
• Place instruments with concave surfaces facing down to prevent the pooling of water.
• Where available, use appropriate attachments to flush inside reamers and devices with lumens or cannula.
• Ensure that soft, high-purity water which is controlled for bacterial endotoxins is used in the final rinse stage.

Note: Automated cleaning may not be suitable for all lumens and cannula, in which case clean manually with a water jet gun, if available, and an appropriate brush (and stilette if provided) that reaches the depth of the feature. After manually cleaning, pass all devices through an automatic cleaning cycle to achieve disinfection.

Note: These instructions have been validated using a washer-disinfector cycle validated to include two cold rinses at <35°C, a detergent cycle and a rinse cycle both at 50°C, a disinfection cycle operating at a temperature of between 80°C and 87°C for a minimum holding time of 1 minute (actual holding time in excess of 2 minutes 50 seconds) and a 20-minute drying cycle. The detergent used was a low foaming, non-ionizing spray wash detergent cleaner (max 12 pH), and the rinse aid was a neutral PH low foaming, non-ionic surfactant with isopropyl alcohol.

1.3 Manual Cleaning

• Use a double sink system (Wash/rinse) dedicated to instrument cleaning (not used for hand washing).
• In the first sink (Wash), keeping the instrument submerged, with an autoclavable brush, apply CE marked cleaning solution to all surfaces until all soil has been removed.
• In the second sink (Rinse), rinse instruments thoroughly with soft, high-purity water which is controlled for bacterial endotoxins, so that the water reaches all parts of the instrument, then carefully dry or use a drying cabinet.
• Ensure that the water temperature does not exceed 35 C
•  Always brush away from the body and avoid splashing
• Pay particular attention to serrations, knurling hinges, ratchets, and tubes. Ensure hinged instruments are thoroughly cleaned in both open and closed positions
• Clean delicate instruments separately to avoid damage.
• Do not use steel wool or steel wire brushes.
• Use only CE Marked detergents with neutral pH (7).

Note: Manual cleaning is NOT a disinfection process

Inspection and Maintenance

After cleaning, visually inspect all surfaces, cannulation, ratchets, joints, holes, and lumens for complete removal of soil and fluids. If ANY soil or fluid is still visible, return the instrument for repeat decontamination.

Lubrication: Apply surgical-grade lubricants to hinges, joints, and moving parts as per the lubricant manufacturer’s instructions. Use only a non-silicon water-soluble lubricant, not an industrial type.

Visually inspect and check: All instruments for damage and wear; cutting edges are free of nicks and present a continuous edge: jaws and teeth align correctly; all articulated instruments have a smooth movement without excess play; locking mechanisms (such as ratchets) fasten securely and close easily, long, slender instruments are not distorted; any component parts fit and assemble correctly with mating components.

Remove for repair or replacement any blunt, worn out, flaking, fractured, or damaged instruments.

Note: if an instrument is returned to the manufacturer/supplier, the instrument must be decontaminated and sterilized and be accompanied by relevant documented evidence.

3.Sterilization Of Instruments

Storage Of Sterilization Instruments

Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.

NOTE: IT IS THE RESPONSIBILITY OF THE PREPROCESSOR TO ENSURE THAT THE REPROCESSING AS ACTUALLY PERFORMED USING EQUIPMENT, MATERIALS, AND PERSONNEL IN THE REPROCESSING FACILITY ACHIEVES THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE PREPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES.