Autoclave Instructions
Generalized Instructions for Reprocessing
All instruments supplied by Artman Instruments should be reprocessed. Surgical assemblies, simple assemblies, hinged instruments (surgical or non-surgical), and all those instruments that contain aluminum are indications for reprocessing.
Contraindication
Any instrument or device that is used in a confirmed or a suspected Creutzfeldt-Jakob disease (CJD) is a contraindication of reprocessing. Such instruments must be destroyed due to the inability to completely rule out the risk of contamination.
Considerations before use
Users should ensure the satisfactory performance of all the instruments. Prior to use, all instruments should be inspected to ensure proper functioning and condition.
It is a must to clean instruments before reprocessing. Remove all protective caps and sheaths with utmost care. The instrument must be:
- cleaned
- lubricated
- decontaminated
- sterilized
- inspected before use
Impact of Reprocessing on instruments
Repeated reprocessing has minimal effect on the instruments. Proper cleaning and lubrication are necessary for prolonging the working. The end of the life of an instrument is determined by wear and tear.
Handling of instruments
The instruments should be used only by trained professionals and personnel having adequate training and familiarity with techniques of procedure. The instruction guidelines should be thoroughly and carefully read before usage.
Cleaning and Sterilization
It is not a recommended practice to leave the used instruments overnight and leave it for the next day. It promotes bacterial growth, and the smell produced may be detrimental to the environment.
Soil removal
Before sterilizing the instruments, all excess soil clotted blood or dirt should be removed. This should be done as soon as possible with a disposable cloth or a gauze.
Preparation for Sterilization
The instruments should be thoroughly checked for any remaining soil. Instruments with assemblies should be prepared with good care. Disassembly of the different mechanical parts should be carried out without the aid of any mechanical tool. Follow the cleaning instructions below before sterilization.
Classification of Instruments Before Sterilization
Critical instruments are those instruments that penetrate the soft tissue, contact bone, enter into the bloodstream, or other normally sterile tissues. These instruments are meant to be dealt with with utmost care and responsibility as they have the highest risk of transmitting infection.
This category includes Surgical instruments, periodontal scalers, scalpels, surgical burs, bone expanders, crown remover tips, and all those instruments that get contaminated by saliva and/or blood.
The sterilization of critical instruments must be in a steamed autoclave machine. The steam sterilization (autoclave) mostly has two built-in programs. Instruments should be exposed to pressurized moist heat
for 17-25 minutes at a temperature of 250/ 121. This procedure is done for packaged instruments that allow penetration of steam. Instruments packed in paper, plastic cloth, and plastic peel pouches should be sterilized in this manner.
For closed metal and glass containers, a cycle of 3-10 minutes at 270132 is recommended.
Semi Critical Instruments
The semi-critical instruments have a lower risk of infection transmission because they contact the mucous membranes or non-intact skin, but will not penetrate soft tissue, contact bone, or enter into/contact the bloodstream or other normally sterile tissue.
This category includes Dental mouth mirrors, amalgam condensers, reusable dental impression trays, dental handpieces.
Semi-critical items should be cleaned, and heat sterilized (as mentioned above in the critical instruments segment). If the instrument is heat-sensitive, it should, at a minimum, be processed with high-level disinfection. Heat-sensitive instruments can be sterilized by immersing them in a liquid chemical germicide registered by the FDA as a sterilant.
Some instruments like “Molar band seaters” and “Mouth gags” fall in this category because of the nylon parts or plastic tubing that they contain.
High-level disinfection is employed for cleaning heat-sensitive semi-critical instruments. Instruments should be dipped in disinfectants approved by FDA, such as Glutaraldehyde, Hydrogen peroxide, and peracetic acid. The instruments need to be exposed for short periods.
Non-critical Instruments
These instruments are at least risk of transmission as they get in contact with intact skin only.
This includes Radiograph holders, cones, blood pressure cuffs, facebow, a pulse oximeter.
Non-critical instruments should be cleaned and disinfected or use disposable barrier protection.
Manual (Required when washer/disinfector method is not used)
- All instruments must be cleaned in the completely open and disassembled (i.e., taken-apart).
- Prepare a neutral pH enzymatic detergent according to the vendor’s directions. A highly alkaline for aluminum instruments is not recommended.
- Completely immerse the device in the prepared detergent as per labeling instructions.
- Allow complete penetration of detergent into the hard to reach areas. This is achieved by actuating all movable parts during soak time.
- Use a soft-bristled brush to scrub the device. Pay utmost attention to the scrubbing of the movable parts, lumens, and crevices. Carry out scrubbing in hard to reach areas until visible soil has been removed.
- Rinse all surfaces, crevices, and lumens in running water (RO/DI) for a minimum of 3 minutes to remove any residual detergent/debris.
- Dry the instruments with a clean, soft cloth.
- Carefully examine each instrument for cleanliness. If any residual soil is visible, repeat the procedure.
Considerations for Lumen devices and Cannulas.
Additional steps are carried out in the procedure:
- For lumen devices, use an appropriately sized syringe filled with a minimum of 15ml of detergent. Flush the lumen with the syringe for at least 7 times.
- Prepare a neutral pH enzymatic detergent in the sonicator and sonicate the instruments for a minimum of 10 minutes. The enzyme solution shall be changed to bloody or turbid color when it becomes grossly contaminated.
- Flush internal lumens at least 3 times with a minimum of 15 ml of RO/DI running water. Flush ports can also be used if available.
Inspection and testing
- Check for smooth movement of hinges. The Locking mechanisms should be smooth and free of nicks.
- Broken, chipped, worn out, or cracked instruments should be kept aside and sent for repair or replacement.
- The stain should be removed from Stained or discolored instruments by soaking them in Cold Soak stain and rust remover. The instructions from the detergent manufacturer should be followed.
- Lubricate all the instruments before autoclaving with Insta-Lube or a steam permeable instrument lubricant.
Packaging of instruments
The instruments can be wrapped in a sterilization wrap, as per the manufacturer’s instructions.
Autoclave Sterilization
The instruments provided by the Artman Instruments are reusable and meet AAMI standards for sterilization. We guarantee our products to withstand a minimum of 20 sterilization cycles according to the criteria listed.
Sterilization can be performed with different techniques. The Autoclave or ethylene Oxide method is a famous one. The Time and Temperature parameters required for sterilization vary according to the type of sterilizer, the packaging material, and the cycle design.
The steps of Autoclave Sterilization are as follows:
- Each healthcare facility should test to ensure the specific configuration of instruments is suitable for sterilization or not.
- Do not sterilize the instruments at temperatures beyond 141 ̊C (285 ̊F).
- All ring handled instruments must be autoclaved in a fully open position. This is done to prevent cracking of the box lock.
- All instruments must be sterilized in an open and disassembled condition/configuration.
- All the flush ports should be in a fully open position.
- All devices should be positioned to allow steam contact of all surfaces.
- All instruments with concave surfaces should be placed so that the surfaces will drain water. The drainage of water is difficult with the concavities of the instrument. Thus, a cautious approach is recommended.
- Verify parameters with the instructions from the sterilizer. According to the CDC guidelines, “The two common steam-sterilizing temperatures are 121°C (250°F) and 132°C (270°F). These temperatures must be maintained for a minimal time to kill microorganisms. Recognized minimum exposure periods for sterilization of wrapped healthcare supplies are 30 minutes at 121°C (250°F) in a gravity displacement sterilizer or 4 minutes at 132°C (270°F) in a pre vacuum sterilizer. At constant temperatures, sterilization times vary depending on the type of item (e.g., metal versus rubber, plastic, items with lumens), whether the item is wrapped or unwrapped, and the sterilizer type.” For all the instruments that have plastic parts, we recommend 30 minutes at 121 degrees centigrade. Since the high temperature decreases the life of plastic, we recommend inspecting each plastic part individually before autoclaving. If any cracks or warpage appear, we recommend disposing of the instrument.
Ultrasonic Sterilization
- Wear Personal Protective Equipment (PPE), including safety eyewear, facemasks, impermeable socks, and gloves to protect yourself from microbial contamination while cleaning and preparing the instruments.
- The biological debris on the instruments (blood and saliva) may dry out. To prevent this, immerse the instruments in an enzymatic presoak or a germicidal soak. PreZyme is a popular enzymatic soak.
- An Ultrasonic Cleaning solution such as UltraDose Germicidal should be used that is diluted to 1 oz. Per gallon of water.
- Instruments to be cleaned are to be placed in a mesh tray or a basket. The tray is then suspended by its handles into the ultrasonic cleaning solution. A complete immersion of the instruments into the solution should be ensured.
- An average cleaning time of 7-10 minutes should be given. The time duration varies according to the load. The temperature is set using the intuitive control panel, and this must be ensured that the temperatures be kept below 107⁰F (42°C).
- When the ultrasonic cleaning cycle is completed, rinse the instruments in water to remove solution residue and then move to the disinfecting/sterilizing steps to complete the process as an interim step Barrier Milk can be used to lubricate hinges and prevent corrosion.
Follow the instructions provided by manufacturers of ultrasonic cleaning equipment and solutions.
Storage
After sterilization, the instruments should remain in a sterilization wrap and stored in a clean and dry cabinet. Care must be taken to protect the jaws from damage. Proper sealing of the instrument container should be ensured.
Maintenance and Repair
Apply lubricant only on the connecting elements and moving parts.
To ensure that all repairs are completed according to the manufacturer’s specifications, the precision instrument should be repaired by Artman Instruments only.
Regardless of age, if any instrument needs service, return it to your authorized service center. All instruments must be cleaned and sterilized prior to sending them.
Warranty
We guarantee every instrument to be free of functional defects in workmanship and materials when used normally for its intended purpose. Any instrument proving defective will be replaced or repaired under our guarantee available online.
We offer product development and customization of surgical instruments
Product development, design modification, or customization of any of the existing products can be carried according to your requirement. Many surgeons want a special kind of modification for a certain tool and we can offer that after signing a “non disclosing agreement”.
Please email us at info@artmaninstruments.com
