Cleaning Instructions
|
Recommended Cleaning and Sterilising Instructions for Stainless Steel and Titanium Instruments.
|
Devices
These instruments are not delivered sterile; and consequently it is necessary to clean and sterilise them properly before use.
These instructions are intended to be used only by persons with the required specialist knowledge and training.
In all cases the approved Hospital procedures must be followed when handling the devices.
|
Warnings
- Instruments must be used for their specified purpose and incorrect use could damage the instrument.
- Our instruments are designed for use by ophthalmic surgeons, who have a good knowledge of their features and how they should be used. Any other use can compromise the safety of the user and the patient. It is the responsibility of the surgeon to choose the most suitable instrument for the surgical technique being performed, based on his experience and expertise.
- Before using, examine the instruments with special lenses. Do not use instruments that show problems or defects.
- Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used. Wherever possible avoid 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 cannula, hinges and blind holes require particular attention during cleaning.
- Do not use peroxide or hydrogen on titanium instruments or on anodised surfaces in order to avoid decolourisation.
Note: When reprocessing medical devices, always handle with care, wearing protective clothing, gloves and eyewear in accordance with local Health & Safety procedures.
|
Limitations on Reprocessing
- Repeated processing has minimal effect on these instruments.
- End of life is normally determined by wear and damage in use.
|
Cleaning: Manual
- Wherever possible, do not allow blood, debris or bodily fluids to dry on the instruments. For best results and to prolong the life of the medical device reprocess immediately after use. If they cannot be reprocessed immediately, use an enzymatic foam spray cleaner to help prevent soil from drying.
- The devices should be cleaned using a Hospital Approved Cleaning Agent that is suitable for use with surgical stainless steel and titanium instruments. BE CAREFUL titanium instruments or those with coloured anodised handles cannot be put in acid solution or alkaline.
- Remove residual matter with a delicate brush or surgical sponge moistened with alcohol. Care should be taken to avoid damage to the extreme tip.
- After cleaning, ensure the instruments are rinsed thoroughly with demineralised water to remove all chemical residues.
- Dry using forced air and inspect under magnification to ensure cleanliness and to check for damage.
|
Cleaning: Ultrasonic
- Ultrasonic cleaning equipment could be used in the cleaning process but not as the sole cleaning method. The instruments should be manually cleaned before being placed in an ultrasonic cleaner.
- Ultrasonic Cleaners should be tested and maintained in accordance with HTM 2030 and it is recommended that devices are cleaned in an Ultrasonic Cleaner with a Hospital Approved Cleaning Agent.
- The instruments should not touch and must be secured on a finger mat during the cleaning procedure. Special care should be taken to make certain that the tip of the instrument does not come into contact with the sides of the ultrasonic container, as this would damage the instrument.
- Use a cleaning cycle lasting approximately 10 to 15 minutes or as recommended in the Ultrasonic Cleaner Instruction Manual.
- After the ultrasonic cleaning, flush all the instruments fully with demineralised water to remove the remainder of the cleaning solutions.
- Dry immediately.
|
Cleaning: Automated
- Use only either CE marked or validated washer-disinfector machines that are tested and maintained in accordance with HTM 2030. Use low-foaming, non-ionising cleaning agents and detergents following the manufacturers’ instructions for use, warnings, concentrations and recommended cycles.
- Load instruments carefully, in accordance with the manufacturers instructions. It is recommended that any box joints and hinges are left open so that any fenestrations in instruments can drain.
- Place heavy instruments with care in the bottom of containers, taking care not to overload wash baskets, and ensure instruments are not touching each other.
- Place instruments with concave surfaces facing down to prevent pooling of water.
- Where available, use appropriate attachments to flush inside reamers and devices with lumens or cannula.
- Instruments should be washed thoroughly in water purified by de-ionisation or reverse osmosis to prevent residues forming on them. It is recommended to use two cold rinses to prevent coagulation on the instruments.
|
Cleaning: Inspection
After cleaning, visually inspect all surfaces, cannulations, 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.
|
Maintenance
Apply surgical grade lubricants to hinges, joints and moving parts as per the lubricant manufacturer's instructions.
|
Inspection and Function Testing
- 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 smooth movement without excess play; locking mechanisms 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 sterilised and be accompanied with the relevant documented evidence.
Packaging
All instruments to be packed following local protocol in accordance with BS standards.
Sterilisation
Instruments can be sterilised using the following methods:-
|
100% ETO Cycles
|
| Concentration ETO: |
850 50mg/l |
| Temperature: |
37°C - 47°C |
| Exposure time: |
3-4 hours |
| Humidity: |
70% RH minimum |
|
Stream autoclaving
|
| Sterilizer type: |
Gravity displacement |
Prevacuum |
| Sample config: |
wrapped |
wrapped |
| Temperature: |
121°C to 123°C |
132°C to 135°C |
| Exposure time: |
15 to 30 minutes |
3 to 4 minutes |
|
'Flash' autoclaving
|
| Sterilizer type: |
Gravity displacement |
Prevacuum |
| Sample config: |
unwrapped |
unwrapped |
| Temperature: |
132°C |
132°C |
| Exposure time: |
3 minutes |
3 minutes |
|
|
|
Above-mentioned sterilization cycles represent industry standards and should be capable of producing a sterile device. Due to variations in sterilization equipment and device bioburden in clinical use, we are not able to produce specific cycle parameters. It is the responsibility of each user to perform a validation and verification of the sterilisation cycle to ensure an adequate sterility assurance level for our products.
|
|
Special notes for Silicone Oil: Silicone oil is extremely difficult to completely remove from the silicone accessories. Therefore, if silicone oil is used in the surgical procedure, all silicone parts that come in contact with the silicone oil, should be replaced.
|
|
Storage
Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.
|