Instructions for Cleaning, Sterilisation, Inspection and Maintenance of Austofix Devices

The reusable instruments provided by Austofix are for use with Austofix implantable devices ONLY and should never be used with any other manufacturer’s implants. The indications for use, and any contraindications for use for the Austofix instrument sets, are determined by the implant being used. Refer to the relevant surgical technique for this information. There are no known side effects from the use of Austofix reusable instruments when correct procedure is followed per the surgical techniques. Instruments manufactured from Aluminium, for example the Tectona tap sleeve, are damaged by alkaline (pH>7) detergents and solution. The following device features present the greatest challenge to cleaning and sterilisation processes of Austofix reusable surgical instruments and require close attention and examination. • • • • • •

Cannulations Internal and external threads Blind holes – particularly blind holes with threads Knurled surfaces Box joints (clamps and retractors) Crevices

All instruments that can be disassembled for cleaning should be disassembled. See special disassembly instructions below.

Limitations on Reprocessing Austofix reusable instruments and single use devices to be sterilised by autoclaving have an indefinite service life. However all orthopaedic instruments can be expected to wear and deteriorate with use and repeated reprocessing. Inspection is required as part of each reprocessing cycle of instruments and implants. This is required to identify instruments that may no longer function correctly or are close to the end of their serviceable life. Those instruments found to fail the inspection should be replaced. Contact an Austofix representative for instrument replacement or repair enquiries. Flash Sterilisation is not recommended for Austofix reusable devices. Instruments or Implants intended to be autoclaved should never be stored wet. Refer to Appendix 1 for Inspection details.

Manufacturer Contact Details: Australian Orthopaedic Fixations Pty Ltd 18 Kinkaid Ave, North Plympton, SA 5037 AUSTRALIA P: (+61) (0) 8 8351 0644 F: (+61) (0) 8 8351 0855 W: www.austofix.com.au

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F40-LG-07 General Requirements for Reprocessing Rev 3

Cleaning and Sterilisation Instructions Below is a table of instructions for the cleaning and sterilisation of Austofix Procedure Kits and implants intended to be cleaned and sterilised prior to implantation. The processes outlined in the chart have been shown to provide clean sterile devices ready for reuse when followed correctly. Details of the chemicals and equipment used for the validation are included below for reference purposes. Alternative methods, chemicals, and equipment for reprocessing may be equally efficient; however Austofix strongly recommends that the processes below are followed to ensure the devices meet all criteria for reuse. In countries other than Australia; in the event of any conflict between these instructions and the national requirements of that country, the national requirements of the other country take precedence over this document. Equipment maintenance and correct use of cleaning agents play important roles in the reproducibility of any cleaning and sterilisation regime. It is the responsibility of the processing facility to ensure that all precautions are taken to ensure correct procedures are followed and equipment is in good working order, and calibrated correctly. Two cleaning methods have been validated by Austofix, and are offered here as alternatives; machine and manual. Machine cleaning should always be used instead of manual cleaning when the correct equipment is available. Machine washing can potentially provide a more consistent result due to the hands off, automated nature of the process. It also reduces exposure of staff to chemicals used for manual cleaning. Chemical concentrations, temperatures and exposure times are dependent on the chemicals used, and all manufacturers’ instructions must be followed correctly. If other chemicals are used in place of the chemicals suggested by Austofix, any compatibility issues between different chemicals and different manufacturers should be researched, understood and followed correctly Occupational Health and Safety Guidelines should be specified and followed by the cleaning facility. Water quality is important and Austofix recommends following the guidelines in AS/NZS 4187:2014; 2.1 Water Quality for Cleaning

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F40-LG-07 General Requirements for Reprocessing Rev 3

Location Theatre (Point of use) Transit to CSSD* Preparation for Cleaning Pre-cleaning

Actions Remove gross soil.

Equipment, Consumables Disposable wipes: cloth or paper

Avoid metallic collisions of cutting edges and drill points. Disassemble where ever possible.

Suitable plastic tray or Austofix sterilisation trays No special tools are required to disassemble Austofix reusable devices

Remove remaining gross soil.

Cannula Brushes, water guns, air guns. Bath with Proteolytic Enzyme Detergent. Water quality: DI, Ro or purified

Rinse under running water. Ultrasonically clean for 5 mins.

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Care should be taken to place small components in fine mesh trays to avoid loss. See additional instructions below. (Pre-cleaning generally only required for heavily soiled devices if Machine Cleaning is going to be used BUT Pre-Cleaning is MANDATORY FOR FULL MANUAL CLEANING)

Ultra Sonic Cleaner to AS 2773.1/2 with approved detergent such as Soniclean Ultrasonic Detergent. Bath for full immersion. Syringes for cannulas. PPE (personal protective equipment)

Ensure full emersion and flood all air pockets. Observe manufacturer operation instructions.

Rinse in Fresh water. Visual Inspection.

Water quality: DI, Ro or purified.

REPEAT if visible soil is still present.

Load washer/disinfector. Connect cannulas to rinse ports. Arrange per machine manufacturer’s instructions. Run cleaning cycle per machine manufacturer’s instructions. Dry.

Batch-type washer complying with AS Load per manufacturer’s instructions. 2945. Cycle must be validated for load size including drying time and temp. Ensure that load capacity of machine is not exceeded.

Soak in enzyme detergent ensuring no air pockets remain. Brush soiled cannulas, knurls and threads (internal and external) operate articulating devices while immersed.

Machine Cleaning

Notes Minimise delay from point of use to CSSD. Soak (<40oC) if delay is likely. Prevent drying: reprocess within 2 hours of use.

Only use machine approved chemicals and water quality.

Follow detergent manufacturer’s specs for concentrations, temperature and soak times.

Allow to dry in machine under auto drying cycle. Ensure items are dry before inspection.

F40-LG-07 General Requirements for Reprocessing Rev 3

OR

Manual Immerse in disinfectant solution. Cleaning/Disinfection Remove all air pockets and soak. Rinse cannulas at least 5 times. Fully rinse all instruments again for 1 minute to remove all disinfectant. Dry with medical compressed air and lint free sterile wipes. Inspection** Visual inspection. Lubricate per manufacturer’s instructions. Check instrument listing for completeness. Packaging Store in AF sterilisation trays or temporary. Wrap per wrap manufacturer’s instructions. Sterilisation Steam Sterilisation Storage

Controlled environment. Monitor Shelf life. *CSSD: Central Sterile Service Department

Large bath, disinfectant solution, brushes for all surfaces and cannulations. Ro/sterile water.

Any approved sterile medical device lubricant.

For example: KIMGUARD® Sterilisation Wrap Equipment to AS4157:2014 for Australian use or similar international standard for non - Australian use. Clean, dry, temperature controlled environment.

Follow manufacturer’s instructions regarding concentrations and temperature.

Visual inspection under good light. Generally magnification is not required but can be used to double check if there is doubt. Repeat cleaning process if devices are still visibly soiled. See AS4157:2014 and ISO 11607

134 degrees for 4 mins, 30 minutes of drying time. Ensure machine maximum load is not exceeded to ensure correct drying occurs. Comply with AS4157:2014

**See specific Inspection Instructions below

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F40-LG-07 General Requirements for Reprocessing Rev 3

Additional Information Cleaning machine recommendations Austofix recommends that all of its reusable instruments or instrument trays which may include implants intended to be autoclaved be mechanically cleaned with either a batch-type washer complying with AS 2945 or surgical equipment rack conveyor washer (tunnel-washer) complying with AS 3836. Validation of the processes described in this document were performed in a batch washer compliant to AS 2945.

Reprocessing staff training Austofix recommends a minimum training level for the personnel responsible for the reprocessing of Austofix reusable devices. In Australia this would be: Certificate III in Sterilisation Services (or any equivalent) In countries outside Australia the recognised minimum training level for the sterilisation department assistants in that country would be recommended. Training should cover, as a minimum: − Compliance with infection control policies and procedures in health work for that country. − Cleaning reusable medical equipment to the manufacturer’s instructions and internal procedures. − Inspection of devices per the manufacturers’ instructions and internal procedures. − Steriliser loads; how to load and what determines a maximum load. − Care and maintenance of sterile stock and storage environment. − Care for surgical instruments. − Following safe manual handling practices.

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F40-LG-07 General Requirements for Reprocessing Rev 3

Disassembly Instructions The majority of disassembly steps applies for the for Austofix reusable instruments only. They are simple and obvious, and do not require any additional explanation or instruction. This includes: • • • •

Unscrewing lock nuts Uncoupling snap lock fittings Dismantling of triple reamers Removal of drill and screw sleeves from Nail Holders or Drill Guides

Several Instruments may require some additional instruction on the correct procedure to prepare for cleaning and inspection:

Tectona Bone Clamp

Back off the lock nut, depress and slide clamp arm out of the body

Remove lock nut

Depress button and rotate 90o. These instructions are repeated on the side of the instrument itself. Note: the button does not fully detach from the body, but remains in place to prevent loss of the spring. However the parts are now easily assessable for simple and complete cleaning

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F40-LG-07 General Requirements for Reprocessing Rev 3

Depth Gauges

Unscrew the locking ring

Remove the end cap

Slide depth scale from the body.

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F40-LG-07 General Requirements for Reprocessing Rev 3

Inspection Guidelines Prior to sterilisation all instruments and non-sterile implants must be inspected to ensure the cleaning process has been successful and that the instruments are in good working condition for reuse. Austofix devices generally do not require inspection under magnification; however in the event that there is any doubt as to the effectiveness of the cleaning, magnification should be used. Inspections must be carried out under good lighting conditions. If any soil remains on instruments that have undergone the cleaning regime; they must be fully reprocessed During the inspection the following areas of focus are important: • • •

Any obvious corrosion Any obvious damage that could impede correct function Any missing components listed on the tray schedule

Some specific items to pay attention to are:

Item

All cannulations

What to look for

Check for obstruction and debris. Ensure cannulated instruments are straight. Check all guides and clips

Check for tip damage causing obstruction to mating components:

Internal and External threads:

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Imbedded debris: ensure all threads have been brushed thoroughly. See below - damage to threads preventing smooth assembly

F40-LG-07 General Requirements for Reprocessing Rev 3

Knurled finger and hand grips

Check for dried or imbedded debris. Check for damage to surface causing raised burrs.

Hinges

Check for smooth function. Check for debris in corners and between components. Lubricate with a sterile lubricant if necessary ONLY after making certain that debris is not the issue. Closely inspect any recess or cavity that could potentially harbour debris.

All recesses and cavities

Drill and reamer cutting flutes;

Impactors

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Sharpness: cutting tips should be free from chips, burrs and rounded edges or bends.

Straightness: long slender objects can be checked for straightness by rolling on a clean and flat stainless steel surface. Check impaction surface for spurs caused by glancing blows. Inspect any welds for signs of fatigue or cracking.

F40-LG-07 General Requirements for Reprocessing Rev 3

Nail Holders

Check nail holder tabs for any damage or bending

Check any blind holes for debris and damage to edges

.

Ensure all sleeves slide freely in Nail Holders and Drill Guides

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F40-LG-07 General Requirements for Reprocessing Rev 3

Screw Driver Tips

Ensure all hex driver tips are in good condition; not too rounded, chipped or broken. Check for worn square tip driver shafts (VRP)

Laser Etched Markings

Devices with a measuring scale should be evaluated against the ability to clearly read the markings under reasonable lighting. Some Drill Guides and Screw Sleeves have dark laser marked rings to act as a depth indicator. These should be clearly visible and unambiguous.

Colour

Inspect the colour of devices, specifically the implants located in instrument trays that are intended to be sterilised by the hospital prior to use.

Note: the above is a guide and representative of what to look for. The person performing the inspection must have some basic knowledge of the functions or general orthopaedic instrumentation. Additional information regarding the particular nature and function of Austofix devices is available in the Surgical Technique documentation. When there is any doubt regarding the status of an instrument, an Austofix representative should be contacted for advice. Alternatively the device should be returned to Austofix for an evaluation. All devices that are deemed to be worn out or broken should be returned to the manufacturer for evaluation. This will assist in the design of better and longer lasting devices.

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F40-LG-07 General Requirements for Reprocessing Rev 3

Background information on the Cleaning and Sterilisation Validation for Austofix Reusable Instruments The following equipment and chemicals were used in the Cleaning and Sterilisation validations for these instructions and is included as a reference only. It is not mandatory that this equipment and these chemicals be used for the above processes.

Automatic Cleaning: Automatic washer/disinfector: Miele model no. G7736 Pro-Clean automatic washer solution All-Dry drying agent for automatic washers

Manual Cleaning: Ultra sonic solution:

Sonic 1

Enzyme cleaners:

Medizyne – Neutral pH Enzyme Cleaner (manual clean)

Disinfectant:

Aidal-Plus (manual disinfect)

Steam Sterilisation: Autoclave:

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Atherton Horizon serial number 040232131501

F40-LG-07 General Requirements for Reprocessing Rev 3