CORICAMA instruments are supplied ‘NON-STERILE’: wash, clean, disinfect, rinse, dry and sterilize before any use.
Instruments must be immediately cleaned and disinfected after each working session using proper cleaning solutions and procedures.
All instruments must always be checked and tested before each use. Defects or deformations affect the proper functioning of the instrument. The use of defective instruments is strictly forbidden. Damaged or worn instruments must be immediately replaced. Damaged or defective instrument can be repaired or replaced solely by CORICAMA.
CLEANING AND STERILIZATION PROCEDURES
IMPORTANT: follow carefully the cleaning indications for the treatment of each material used for the manufacturing of CORICAMA instruments provided at the end of this document.
IMPORTANT: follow carefully the instructions procedures provided by the sterilization equipment and by the cleaning solutions manufacturers. Chose the correct dosage of the cleaning solution, the correct washing/sterilization time, pressure and temperature.
CORICAMA instruments are resistant to corrosion and discolouration. When instruments are exposed for longer time or higher temperatures than recommended, or cleaned with wrong solutions or detergents with higher than recommended chemical concentrations (Sodium Hypochlorite, household bleach, tartaric acid, stain and tartar remover, Aqua Regia, Sulfuric Acid, Hydrochloric Acid or Iodine, etc.), instruments could be affected by rust, corrosion, oxidation and discolouration.
Instrument Processing Area: Cleaning and sterilizing operations must be exclusively carried out by authorised personnel only in areas duly equipped and specifically assigned to this purpose (separated from the patient treatment area) to avoid the risk of cross-contamination of sterilized items via contact with contaminated items and equipment. Personnel should wear heavy-duty utility gloves when handling used sharp items (during the removal, transport, cleaning and packaging processes) to help prevent accidental puncture injury.
INSTRUMENT PROCESSING WORK FLOW
1. INSTRUMENT MANUAL/MECHANICAL CLEANING
Dirt and residuals have to be removed from the instruments. Clean the instruments with a gauze and alcohol in order to wipe off any residual or debris of composite material. This makes easier the ultrasonic bath cleaning and avoids permanently harming the surface finish of the instruments with the manual removal of any debris when dried.
Multiple-part instruments should be disassembled or rather opened.
Pre-rinse and submerge the instruments into hot water at around 95°F/35°C for at least 5 minutes.
Clean them with a soft brush under hot water until no residues can be seen taking special care of cavities, boreholes or hinges.
2. DISINFECTION
Chemical agents: submerge the instruments into an appropriate disinfection solution with a non-corrosive neutral pH. Use approved cleaning solutions only. Never use household bleach or stain and tartar remover.
Do not use any abrasive brushes or materials to clean instruments. Rinse under hot water at about 95°F/35°C to remove the disinfection solution from the instruments.
Washer/thermo-disinfector: load the instruments into the washing chamber and select the cycle according to manufacturer’s instructions to obtain an effective treatment and an optimal preparation for sterilization.
Ultrasonic bath cleaning: use ultrasonic bath cleaning for 15 minutes at 95°F/35°C with enzymatic or mild detergent (a neutral pH cleaning solution). Solution should be changed every 8 hours (at least once a day) to avoid microorganisms to accumulate.
Note: (1) ultrasonic cleaning will not remove hardened cement or composite debris. See previous instrument manual/mechanical cleaning procedure to remove cement or composite while still soft and not dried.
(2) Loose instruments vibrated together without protection in an ultrasonic cleaner could be damaged (chipped or broken tips, scratches). Preparing instruments into a sterilization cassette will held them securely in place protecting from rubbing against other instruments.
3. RINSING
Rinse instruments thoroughly under stream of hot water at around 95°F/35°C to remove the disinfection solution from the instruments and dip in alcohol after rinsing.
4. DRYING
Thoroughly dry instruments prior to sterilization to prevent stains, spots, rust, corrosion and discolouration.
5. INSPECTION AND LUBRICATION
Inspection: visually inspect the instruments for any remaining debris and if necessary clean again.
Lubrication: to prevent rust, corrosion and stiff joints and to ensure smooth operation: pliers, needle holders, hemostats, forceps, rongeurs, scissors, orthodontic pliers and all other hinged instruments should be lubricated with the proper lubricant (CORICAMA Lubricating Oil – do not use household lubricants or lubricants not suitable for medical use).
6. PACKAGING
Instruments (loose or combined into cassettes) should be packaged in a pouch or wrap made of material intended for the particular type of sterilization process (e.g., self-sealed or heat-sealed plastic and paper pouches, paperplastic rolls/tubing and sterilization wraps) allowing penetration of the sterilant, preventing contamination during handling, providing an effective barrier to microbial penetration and maintaining the sterility of the processed instrument after sterilization.
Hinged instruments: always keep all hinged instruments in the open position.
7. INSTRUMENT STERILIZATION
IMPORTANT:
• Instruments need to be cleaned and thoroughly dried before they are wrapped and sterilized to avoid stains, spots, rust, corrosion and discolouration.
• Sterilize by not exceeding 275°F/135°C according to autoclave manufacturer’s instructions.
• Set pressure and time according to autoclave manufacturer’s instructions.
• Drying and cooling time: at least 10 minutes
• Use open or perforated containers, do not use closed/not perforated containers
• When loading packages into the sterilizer, they must remain intact without being pierced or damaged during loading.
• Unwrapped items become contaminated after cycle
• Special care for plastic and rubber items that could be damaged.
• Hinged instruments: always keep all hinged instruments in the open position during sterilization.
STEAM AUTOCLAVE: saturated steam needed to sterilize the instruments is produced from distilled water through pressurization and high temperature. Wrapped or pouched instruments are sterilized by the penetration into sterilization packaging by the steam. Attention shall be paid to ensuring full respect of temperature, pressure and timing to avoid corrosion, discolouration or deformation, and damages to instruments made of or with components made of rubber and plastic.
DRY HEAT OVEN STERILIZERS: instruments are sterilized through dry heating to high temperature (higher than steam autoclaves). Dry heat sterilization is useful for instruments that can be damaged by steam but attention shall be paid to ensuring full respect of temperature and timing to avoid discolouration or deformation, and damages to instruments made of or with components made of rubber and plastic.
CHEMICLAVES USING UNSATURATED CHEMICAL VAPOR: the chemical vapor is produced using water-free chemicals and is useful for instruments that can be damaged by steam. Attention shall be paid to ensuring full respect of temperature and timing to avoid discolouration or deformation, and damages to instruments made of or with components made of rubber and plastic.
“COLD STERILIZATION” WITH LIQUID CHEMICAL GERMICIDES/AGENTS: sterilization is obtained through the immersion of the instruments into the appropriate solution by respecting the correct dosage and the correct time indications suggested by the chemical germicides/agents manufacturer. Instruments sterilized in this manner should be rinsed with sterile water, dried and placed in a sterile container (if not used immediately).
8. INSTRUMENT STORAGE AND HANDLING
Storage
Keep the sterilized instruments wrapped and sealed inside their sterilization pouch, and store them in a dry, clean and dust-free environment with moderate temperatures from 41°F/5°C to 104°F/40°C.
Handling
• GAMMAFIX® sterilization cassettes allow to move instruments without touching or damaging the instruments and reducing the chance for injuries.
• Instruments can be systematically organized according to treatment avoiding to spend time looking for missing instruments.
• Instruments are kept together through cleaning, rinsing and drying processes reducing the potential for breakage or loss.
• Cassettes with instruments are ready to use or storage after being wrapped and placed in autoclave for sterilization.
CLEANING INDICATIONS FOR THE TREATMENT OF EACH MATERIAL USED FOR THE MANUFACTURING OF CORICAMA INSTRUMENTS
STAINLESS STEEL INSTRUMENTS can be cleaned by manual/mechanical cleaning, washer/thermo-disinfector, ultrasonic bath cleaning and sterilization (steam autoclave, dry heat oven/sterilizers and chemiclaves using unsaturated chemical vapor).
Sterilization: do not exceed 275°F/135°C (2.1 bar) according to autoclave manufacturer’s instructions.
POLYMER HANDLE INSTRUMENTS can be cleaned by manual/mechanical cleaning, washer/thermo-disinfector, ultrasonic bath cleaning and sterilization (steam autoclave, dry heat oven/sterilizers and chemiclaves using unsaturated chemical vapor).
Sterilization: do not exceed 275°F/135°C (2.1 bar) according to autoclave manufacturer’s instructions.
Polymer handle instruments are NOT compatible with dry heat or rapid dry heat sterilizers.
ANODIZED ALUMINUM INSTRUMENTS can be cleaned by manual/mechanical cleaning, washer/thermo-disinfector and sterilization (steam autoclave and chemiclaves using unsaturated chemical vapor).
Sterilization: do not exceed 275°F/135°C (2.1 bar) according to autoclave manufacturer’s instructions.
Sterilize anodized aluminum instruments separately from stainless steel instruments.
Do not clean anodized aluminium instruments by ultrasonic bath cleaning.
The colour of the products made in aluminium may be damaged by the use of some chemical cleaners. Avoid extremely alkaline or extremely acid chemicals, as well products that contain Sodium or Potassium. Read carefully the instructions on the chemicals you use for the cleaning and always pay special attention to the incompatibilities with aluminum. Use chemical solutions with pH between 4 and 8.
TITANIUM INSTRUMENTS can be cleaned by manual/mechanical cleaning, washer/thermo-disinfector and sterilization (steam autoclave and chemiclaves using unsaturated chemical vapor).
Sterilization: do not exceed 275°F/135°C (2.1 bar) according to autoclave manufacturer’s instructions.
Do not clean titanium instruments by ultrasonic bath cleaning.
INSTRUMENTS WITH TC (TUNGSTEN CARBIDE INSERTS) can be cleaned by manual/mechanical cleaning, washer/thermo-disinfector, ultrasonic bath cleaning and sterilization (steam autoclave, dry heat oven/sterilizers and chemiclaves using unsaturated chemical vapor).
Sterilization: do not exceed 275°F/135°C (2.1 bar) according to autoclave manufacturer’s instructions.
Never submerge in sterilizing solutions containing benzyl ammonium chloride (BAC) as it will soften and dissolve the tungsten carbide.
FURTHER RECOMMENDATIONS
Staining: is most frequently the result of improper or inadequate cleaning caused by mineral deposits in the water.
To avoid stains, spots, rust, corrosion and discolouration:
• Use only distilled water for sterilizer’s reservoir as hard water may leave deposits.
• Use distilled water for cleaning and disinfecting to avoid discoloration and staining
• Prolonged immersion in disinfecting or sterilizing solution can damage the instruments.
• Avoid using cleaning agents with ammonia and always rinse instruments thoroughly to remove residues of chemicals.
• Never use saline solution, iodine, chloride, bleach or other aggressive substances to avoid corrosion and eventually irreversible pitting.
• Sterilizer chamber and filters should be cleaned weekly or per manufacturer recommendations
• Do not overload and keep instruments and cassettes slightly separated on the racks within the chamber.
Spotting: is usually the result of improper cleaning caused by the water in which instruments are washed or by detergent residues in the sterilization pouches.
• Thoroughly dry instruments before loading them in the autoclave avoiding using cloths with detergent residues.
Rust/Corrosion: If an instrument is corroding, it should be removed and no longer used.
• Avoid the use of abrasives in the cleaning process, which can wear away the protective passive steel layer on the surface of the instrument.
• A sterilization exceeding the suggested pressure, temperature and timing weakens the temper of the instrument (lowering its performance) and darkens the instrument with a yellow/brown colour similar to oxidation.
• Avoid rust transfer between instruments by washing and sterilizing instruments of different metals (stainless steel, aluminium, titanium, chrome, etc.) keeping them in separated trays.
• Stains, spots or rust contamination may occur when there are already other contaminated instruments in the sterilizer: sterilize contaminated instruments separately.
Note: many instruments on the market have a chrome plating which covers a lower quality steel. When the chrome plating scratches, the lower quality steel become exposed and it can rust and/or corrode during sterilization. This rust and/or corrosion can pass to healthy instruments.
Breakage: instruments are designed for a specific purpose and should be used only for that purpose. Even the strongest instrument can be damaged when used inappropriately. An instrument should not normally break if it is being used for its intended purpose. Breakage is likely the result of either an instrument being used for something other than what it was designed for, or being used to perform a task beyond its capacity.
• During ultrasonic cleaning or autoclave sterilization instruments should be cleaned and autoclaved in the open, not locked, position to avoid the heat may make the instrument expand and crack the box joint/hinge.