MO Milling Surgical Instruments Cleaning and Handling Instructions
content ( 𝐶𝑎𝐶𝑂3 > 120 mg/L), often referred to as hard water, is not
Cleaning and Handling of MO Milling Surgical Instruments
suitable for pre-cleaning, washing and rinsing the instrument. Softened, filtered, demineralized, or distilled water must be used during the procedures of cleaning/disinfection and autoclaving to minimize the
MO Milling single-use and re-usable surgical instruments are supplied clean and non-sterile. They must be sterilized before use. Re-usable surgical instruments must be properly re-processed.
information will help assure the cleanliness and performance of the instruments. WARNINGS & PRECAUTION Follow instructions and warnings as issued by the manufacturers of any decontaminants, disinfectants and cleaning agents used.
possible avoid use of mineral acids and, harsh/abrasive agents. No part of the process shall exceed 140°C. The cleaning procedure, to remove contaminants from the devices, must be done by immersing the device in room temperature neutral pH (7) cleaning agent. A cleaning agent can be an enzymatic cleaner, detergent
risk that chlorides react with the passive layer, leading to pitting corrosion.
CLEANING If not done immediately after rinsing, instruments should be submerged in a solution of water and neutral PH (7) cleaning agent. Ultrasonic Cleaning
The quality of the final cleaning process’ rinse water and the water used
For micro and delicate instruments, use manual cleaning. Instruments
for the generation of steam for the sterilizing shall comply with the
should be processed in a cleaner for the full recommended cycle time –
requirements in Table 1.
usually 5 to 10 minutes.
Flash sterilization is not recommended as this does not undertake a drying
Place instruments in an open position into the ultrasonic cleaner. Make
cycle, therefore commencing the process of corrosion.
sure that "sharp" (scissors, knives, etc.) blades do not touch other
Ethylene Oxide (EtO) and Hydrogen Peroxide Plasma are acceptable methods to sterilize stainless steel, titanium, aluminium and polymer instruments but are not recommended.
instruments. All Instruments have to be fully submerged. Do not place dissimilar metals (stainless, copper, chrome plated, etc.) in the same cleaning cycle.
Change solution frequently – at least as often as
manufacturer recommends. Rinse instruments after ultrasonic cleaning
Devices with long, narrow cannula, hinges and blind holes require particular attention during cleaning.
with water to remove ultrasonic cleaning solution. Automated Cleaning
LIMITATIONS OF RE-PROCESSING
Use only marked or validated washer-disinfector machines and cleaning
Repeated processing on devices made of stainless steel, titanium and
agents, following the manufacturer's instructions for use, warnings and
aluminium will not adversely affect them. Re-processing of standard
recommended cycles. Load instruments carefully, with any box joints and
polymers are limited by their heat resistance (Tg, dimensional stability)
hinges open and so that fenestrations in instruments can drain. Place
and their hydrolytic resistance in multiple sterilization cycles. Generally,
heavy instruments carefully in the bottom containers. Place instruments
DO NOT use high acidic (pH <4) or high alkaline (pH >10) products for
the end of life of an instrument is determined by normal wear and damage
with concave surfaces facing down.
disinfection or cleaning of stainless steel, titanium and aluminium, since
due to use.
or rinse aid. A cleaning agent should be biodegradable, non-corrosive, non-toxic, non-abrasive, low foaming, free rinsing and preferably in liquid form.
these can corrode, cause discoloration or stress fractures. Prolonged exposure to saline solution will lead to pitting and stress corrosion
INSTRUCTION FROM POINT OF USE
Manual cleaning is not advised if an automatic washer-disinfector is
cracking. DO NOT immerse the used device in a physiological salt (NaCl)
If possible, soiled instruments should be placed in a holding solution
(combined disinfectant/enzyme solution) immediately after use and prior
Cleaners such as Isopropyl Alcohol, bleaches and peroxides may attach to the polymer chains of some thermoplastic resins and cause crazing, stress cracking or even breakage. Avoid strong acids and bases (Note: bases decompose forming formaldehyde) and strong oxidizing agents. Generally, semi-crystalline polymers will have better resistance to
to cleaning. Immediately after surgery, rinse instruments under warm (not hot) running water. Rinse should remove all blood, body fluids and tissue. The pre-treatment of a used instrument at the point of use, shall not compromise the subsequent cleaning and sterilization process, and shall not cause damage on it. PREPARATION FOR DECONTAMINATION
Water quality is a critical consideration in all stages of the reprocessing of
Disassemble where intended by trained staff only, without use of tools
the instrument. Attention should be paid to the quality of water that is
unless specifically provided by the manufacturer.
used for the pre-cleaning, washing and rinsing of the instrument, and for
instruments as soon as possible following use.
cleaning process and damage the instrument. Water with high mineral TD-008_05_CleaningAndHandlingOfMoMillingSurgicalInstruments
Using a sink dedicated for instrument cleaning (not used for hand washing), rinse excess soil from instruments (water temp >35°C). Keeping instruments submerged in water, use a brush to apply cleaning solution to all surfaces. Pay particular attention to serrations, teeth, ratchets and hinges always brush away from the body. Ensure hinged instruments are thoroughly cleaned in both open and close positions. Rinse instruments
common hospital cleaners than amorphous polymers.
dilution of cleaning agents. Water of poor quality can adversely affect the
available. If needed, use the following process:
thoroughly with clean water, so that water reaches all parts of the
instrument. Carefully hand dry or use industrial drying cabinet. INSPECTION The cleaning process should ensure that all soil is removed prior to the sterilization of the instrument. This will prevent compromising the sterilization process. After cleaning, check all surfaces, cannulations, Page 1 of 2
holes and lumens for complete removal of soil. If any soil is still visible,
return instrument for repeat decontamination.
132°C (269.6°F), 3 minutes full cycle time and 30 minute minimum dry time.
Check that cutting instruments and knives have sharp, have undamaged blades.
The higher temperature is preferred to the lower because the cycle time
On completion of the cleaning process, the instrument should also be free from cleaning agent residue. MAINTENANCE & FUNCTIONAL TESTING To prevent instruments with box locks, hinges and any moving parts from ”freezing”, they need to be lubricated regularly. Minimally invasive
is too long to be practical. If the instrument has a polymer component such as Polyethylenimine (PEI) and Acetal Copolymer (POM-C), it is best to use the lower temperature. NOTES: 1.
than those listed above. However it is then the responsibility
The lubricant has to be biocompatible, surgical grade, water soluble and
of the user to validate the specific action.
intended for heat sterilized medical instruments. DO NOT use a silicone spray as this will render the instrument unsterile. Apply lubricant after
cleaning and before sterilizing. Lubrication is not a substitute for correct cleaning. Ensure instruments are correctly cleaned prior to lubrication.
Visually inspect and check all instruments: for wear and tear, scissors blades glide smoothly all the way, jaws and teeth are aligned correctly, articulated instruments move smoothly & without excessive play, locking instruments are not distorted, component parts fit and assemble correctly. Suction tubes are clean inside. Retractors function properly.
Maximum concentrations/levels in supply water ≤ 10 mg/L ≤ 1 mg/L ≤ 0.2 mg/L ≤ 0.005 mg/L ≤ 0.05 mg/L ≤ 0.1 mg/L ≤ 2 mg/L ≤ 0.5 mg/L ≤ 15 µS/cm 5.0 to 7.5 Colourless, clear, with no visible deposits ≤ 0.02 mmoll/L (2 mg/L as 𝐶𝑎𝐶𝑂3 )
Mineral residues Silicates Iron Cadmium Lead Heavy metal residues Chloride Phosphate Conductivity (at 25° C) pH value Appearance Hardness ∑(of alkaline earth ions) Table1. Chemical purity of final cleaning process rinse water and water used for steam generation.
Steam sterilization cycles with longer times than those listed
CLEANING OF POLYURETHANE SURFACES/DEVICES NOT TO BE
are also acceptable.
Drying times vary according to load size and should be
Clean the surface using a microfiber cloth diluted in neutral (pH 5-8)
increased for larger loads.
disinfectant detergent foam. The foaming agent should be compatible with the polymer-based material. Clean from top to bottom then left to
mechanisms (ratchets) fasten securely and close easily, long and slender
Remove for repair/replacement any blunt, worn out, fractured, flaking or
Local or national specifications may be followed where steam sterilization requirements are stricter or more conservative
instruments also require particular attention to moveable components.
For loaded Instrument Trays, autoclaving (prevacuum) at
Sterilizing process shall be performed in a sterilizer chamber
right. Follow the disinfectant manufacturer’s recommended contact time
that has undergone installation qualification (IQ), operational
to obtain microbial reduction. Wipe surfaces with a microfiber cloth
qualification (OQ), and performance qualification (PQ)
humidified with water. Always wipe in the same direction. Dry surfaces
with a dry microfiber cloth. DO NOT use disinfectants that contain phenol.
Always follow autoclave manufacturer's instructions. When sterilizing
chlorinated, ketone, ether or ester solvents. NEVER use abrasive agents,
multiple instruments in one autoclave cycle, ensure that the sterilizer
strong acids, strong solvents (acetone), products with a pH>9 or iodized
manufacturer's stated maximum load is not exceeded.
products. DO NOT immerse or allow water, cleaning products or other
instruments are dry before sterilization.
liquids inside the mechanisms. DO NOT sterilise.
All instruments have to be packed following local protocol and standards.
Instruments containing PE (Polyethylene) and UHMWPE (Ultra High
The use of cleaning disinfecting foam with the following minimal
Sealing methods that compromise the integrity of the sterile barrier
Molecular Weight Polyethylene) cannot be steam sterilized. They should
microbiological properties is recommended:
system shall not be used (string, non-adhesive tape, staples, pins and
be sterilized by ethylene oxide (EtO) or other validated sterilization
elasticized bands are not suitable as sealants). Let instruments air dry and
EN 1040, EN 13727, EN 1276, EN 14561
Mycobacterium tuberculosis (B.K.)
EN 1275 (Candida albicans), EN 14562 (Aspergillus niger,
Aspergillus fumigatus, EN 13624 HIV-1, BVDV (HCV virus model), PRV (HBV virus model),
store them in a clean and dry environment. STERILIZATION
STORAGE Instruments must be thoroughly dried before they are stored.
The following are recommended as a minimum cycle for steam
Instruments that have been processed and wrapped to maintain sterility
sterilization to achieve a SAL of ≤10−6
should be stored in a manner to avoid extremes in temperature and
Autoclaving at 121°C (249.8°F), 15 minutes exposure time, 15 psi with a 30-minute dry time.
Autoclaving at 134°C (273.2°F), 3 minutes exposure time, 29.5
moisture. Care must be taken in handling wrapped cases to prevent
Rotavirus, Herpes Virus, H5N1 Influenza virus (avian strain), Fline Calicivirus (Norovirus virus model)
damage to the barrier. The healthcare facility should establish a shelf life for wrapped instrument cases based upon the type of sterile wrap used and the recommendations of the sterile wrap manufacturer.
psi with a 30-minute dry time. TD-008_05_CleaningAndHandlingOfMoMillingSurgicalInstruments
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