Care & Cleaning Information
Surgical instruments are designed to perform many specific functions. The use of any instrument for tasks other than those for which they are intended may result in damage or breakage. The proper cleaning, handling and sterilization procedures will ensure that your surgical instrument will perform as intended and extend its useful life.
How Supplied
The instrument is supplied non sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document, unless stated otherwise with the packaging of the product.
Inspection & Function Testing
Visually inspect and check the instrument for damage and wear; 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. Remove for repair or replacement any worn out, fractured or damaged instruments.
Precautions
Delicate surgical instruments require special handling to prevent damaging. Use caution during cleaning and sterilization. A non fibrous sponge should be used to wipe off all blood and surgical debris. Do not apply excessive stress or strain to the joints, misuse will result in damage. Do not apply excessive stress during use. Instruments manufactured of different metals should be processed separately to avoid electrolytic action between the different metals.
Care & Handling
The procedures outlined below are recommended to ensure safe handling of biologically contaminated surgical instruments. All instruments must be sterilized before use. NOTE: When reprocessing medical devices always follow local Health & Safety procedures.
Warnings
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 can be damaged by higher alkaline solutions, (pH >10). Devices with long hinges and blind holes require particular attention during cleaning.
Note:Single use devices must not be reprocessed and reused.
Limitations on Reprocessing
Repeated processing has minimal effect on stainless steel surgical instruments. End of life is normally determined by wear and damage in use.
1. Pre - Cleaning
Wherever possible, do not allow blood, debris or bodily fluids to dry on instruments. For best results and to prolong the life of the medical device reprocess as soon as it is reasonably practical following use. If they cannot be reprocessed immediately, use an enzymatic cleaner to help prevent soil from drying.
2. Cleaning (Cleaning Precautions)
Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus, blood or other bodily fluids. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents.
a. Automated Cleaning
Use only either CE marked or 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 hinges open and 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. 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. 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 stiletto 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 2 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 ionising spray wash detergent cleaner, (max 12pH), and the rinse aid a neutral pH low foaming, non ionic surfactant with isopropyl alcohol.
b. Manual Cleaning
Manual cleaning is not advised if an automatic washer-disinfector is available. If this equipment is not available use the following process:
i. Use a double sink system (wash / rinse) dedicated for instrument cleaning, (not used for hand washing). Ensure that the water temperature does not exceed 35°C.
ii. In the first sink, keeping the instrument submerged, with an autoclavable brush, apply CE marked cleaning solution to all surfaces until all soil has been removed. Pay particular attention to hinges, always brushing away from the body and avoiding splashing. Ensure hinged instruments are thoroughly cleaned in both opened and closed positions.
iii. In the second sink 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 hand dry or use a drying cabinet.
iv. After cleaning, visually inspect all surfaces, cannulations, 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.
Note: Manual cleaning is NOT a disinfection process: when manual cleaning is used it may not be possible to disinfect the device prior to further handling.
3. Lubrication / Assembly / Inspection
Special attention should be given to the lubrication of joints and moveable parts. Do not use mineral oil, petroleum or silicone based products. To lubricate joints use a non silicone water soluble lubricant prior to sterilization.
Mechanically test the working parts to verify that each instrument performs correctly.
Visually inspect and check: all instruments for damage and wear; 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. Remove for repair or replacement any worn out, flaking, fractured or damaged instruments.
Note: If a product is returned, the instrument must be decontaminated and sterilized and be accompanied with the relevant documented evidence.
Note: Instruments must be in the unstressed condition before sterilization to avoid temperature induced stress cracks in the joints.
Note: All instruments to be packed following local protocol in accordance with British Standards.
4. Sterilization
Either CE marked or validated vacuum autoclave operating at 134 - 137°C 2.25 bar for a minimum holding time of 3 minutes - always following the instructions of the machine manufacturer.
When sterilizing multiple instruments in one autoclave cycle, ensure that the sterilizer manufacturer's stated maximum load is not exceeded. Ensure instruments are dry prior to sterilization.
5. Storage
Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.
6. Additional Information
Cleaning and sterilizing guidelines are available in HTM 2030, HTM 2010, BS EN 554 (from all good stationery offices) and ABHI, Report on the Validation of a Reprocessing Instruction Template for Generic Class I Medical Devices (Ref: SI SIS 0038).
NOTE: IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING AS ACTUALLY PERFORMED USING EQUIPMENT, MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY ACHIEVE THE DESIRED RESULT. THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS. LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES.
How Supplied
The instrument is supplied non sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document, unless stated otherwise with the packaging of the product.
Inspection & Function Testing
Visually inspect and check the instrument for damage and wear; 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. Remove for repair or replacement any worn out, fractured or damaged instruments.
Precautions
Delicate surgical instruments require special handling to prevent damaging. Use caution during cleaning and sterilization. A non fibrous sponge should be used to wipe off all blood and surgical debris. Do not apply excessive stress or strain to the joints, misuse will result in damage. Do not apply excessive stress during use. Instruments manufactured of different metals should be processed separately to avoid electrolytic action between the different metals.
Care & Handling
The procedures outlined below are recommended to ensure safe handling of biologically contaminated surgical instruments. All instruments must be sterilized before use. NOTE: When reprocessing medical devices always follow local Health & Safety procedures.
Warnings
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 can be damaged by higher alkaline solutions, (pH >10). Devices with long hinges and blind holes require particular attention during cleaning.
Note:Single use devices must not be reprocessed and reused.
Limitations on Reprocessing
Repeated processing has minimal effect on stainless steel surgical instruments. End of life is normally determined by wear and damage in use.
1. Pre - Cleaning
Wherever possible, do not allow blood, debris or bodily fluids to dry on instruments. For best results and to prolong the life of the medical device reprocess as soon as it is reasonably practical following use. If they cannot be reprocessed immediately, use an enzymatic cleaner to help prevent soil from drying.
2. Cleaning (Cleaning Precautions)
Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus, blood or other bodily fluids. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents.
a. Automated Cleaning
Use only either CE marked or 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 hinges open and 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. 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. 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 stiletto 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 2 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 ionising spray wash detergent cleaner, (max 12pH), and the rinse aid a neutral pH low foaming, non ionic surfactant with isopropyl alcohol.
b. Manual Cleaning
Manual cleaning is not advised if an automatic washer-disinfector is available. If this equipment is not available use the following process:
i. Use a double sink system (wash / rinse) dedicated for instrument cleaning, (not used for hand washing). Ensure that the water temperature does not exceed 35°C.
ii. In the first sink, keeping the instrument submerged, with an autoclavable brush, apply CE marked cleaning solution to all surfaces until all soil has been removed. Pay particular attention to hinges, always brushing away from the body and avoiding splashing. Ensure hinged instruments are thoroughly cleaned in both opened and closed positions.
iii. In the second sink 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 hand dry or use a drying cabinet.
iv. After cleaning, visually inspect all surfaces, cannulations, 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.
Note: Manual cleaning is NOT a disinfection process: when manual cleaning is used it may not be possible to disinfect the device prior to further handling.
3. Lubrication / Assembly / Inspection
Special attention should be given to the lubrication of joints and moveable parts. Do not use mineral oil, petroleum or silicone based products. To lubricate joints use a non silicone water soluble lubricant prior to sterilization.
Mechanically test the working parts to verify that each instrument performs correctly.
Visually inspect and check: all instruments for damage and wear; 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. Remove for repair or replacement any worn out, flaking, fractured or damaged instruments.
Note: If a product is returned, the instrument must be decontaminated and sterilized and be accompanied with the relevant documented evidence.
Note: Instruments must be in the unstressed condition before sterilization to avoid temperature induced stress cracks in the joints.
Note: All instruments to be packed following local protocol in accordance with British Standards.
4. Sterilization
Either CE marked or validated vacuum autoclave operating at 134 - 137°C 2.25 bar for a minimum holding time of 3 minutes - always following the instructions of the machine manufacturer.
When sterilizing multiple instruments in one autoclave cycle, ensure that the sterilizer manufacturer's stated maximum load is not exceeded. Ensure instruments are dry prior to sterilization.
5. Storage
Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.
6. Additional Information
Cleaning and sterilizing guidelines are available in HTM 2030, HTM 2010, BS EN 554 (from all good stationery offices) and ABHI, Report on the Validation of a Reprocessing Instruction Template for Generic Class I Medical Devices (Ref: SI SIS 0038).
NOTE: IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING AS ACTUALLY PERFORMED USING EQUIPMENT, MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY ACHIEVE THE DESIRED RESULT. THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS. LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES.