Instructions for Re-Processing Reusable Devices
The following instructions are for all reusable medical devices shown in this catalogue, unless stated otherwise with the packaging of the product. These instructions are intended for use only by persons with the required specialist knowledge and training.

Cleaning: Inspection
• After cleaning, check all surfaces, cannulations, holes and lumens for complete removal of soil.
• If any soil is still visible, return the instrument for repeat decontamination.
Note: automated cleaning may not be suitable for all lumens and cannulae, in which case clean manually with an appropriate brush (and stilette if provided) that reaches the depth of the feature.

Maintenance
• Apply surgical grade lubrication oil to hinges, joints and moving parts as per the lubrication oil manufacturer’s instructions.

Inspection and Function Testing
• Visually inspect and check:-
All instruments for damage and wear
Cutting edges are free of nicks and present a continuous edge
Jaws and teeth align correctly
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
any component parts fit and assemble correctly with mating components
• Remove for repair or replacement any blunt, worn out, flaking, fractured or damaged instruments.
Note: if an instrument is returned to the manufacturer/supplier, the instrument must be decontaminated and sterilised and be accompanied with the relevant documented evidence.

Packaging
• All instruments to be packed following local protocol in accordance to BS standards.

Sterilisation
• 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 sterilising multiple instruments in one autoclave cycle, ensure that the steriliser manufacturer’s stated maximum load is not exceeded.
• Ensure instruments are dry before sterilisation. If the instruments cannot be dried prior to sterilisation, then use distilled/de-ionised water in the final-rinse stage of cleaning.

Storage
• Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature and away from direct sunlight.

Additional Information
• Other forms of cleaning (ultrasonic, alkaline and neutral) and sterilisation (Low Temperature Steam, Formaldehyde, Ethyleneoxide and Gas Plasma) are available. However, always follow the instructions for use as issued by the manufacturer and always consult with them if in any doubt over the suitability of any process used.
* Follow cleaning and sterilisation guidelines as per HTM 2010 and HTM 2030.

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 140ºC.
• Aluminium based products are damaged by high alkaline solutions (pH>10)
• Devices with long, narrow cannula, hinges and blind holes require particular attention during cleaning.

Limitations on Reprocessing
• Repeated processing has minimal effect on these instruments.
• End of life is normally determined by wear and damage in use.
• Any specific limitations on the number of reprocessing cycles shall be made available with the instrument.

INSTRUCTIONS
From Point of Use
• If possible, soiled instruments should be placed in a holding solution (combined disinfectant/enzyme solution) immediately after use and prior to cleaning, avoiding the use of bleach-based solutions.
Note: this process is not suitable for aluminium instruments.

Preparation for Decontamination
• Disassemble where intended by trained staff only, without the use of tools unless specifically provided by the manufacturer.
• Reprocess all instruments as soon as it is reasonably practical following use.

Cleaning: Automated
• Use only either CE marked or validated washer-disinfector machines and cleaning agents, following the manufacturers’ instructions for use, warnings and recommended cycles.*
• Load instruments carefully, with any box joints and hinges open and so that any fenestrations in instruments can drain.
• Place heavy instruments with care in the bottom of containers.
• Place instruments with concave surfaces (e.g. curettes) facing down to prevent pooling of water.

Cleaning: Manual
• Manual cleaning is not advised if an automatic washer-disinfector is available. If this equipment is not available, use the following process:-
One: Using a sink dedicated for instrument cleaning (not used for hand washing), rinse excess soil from instrument (water temp <35 C).

Two: Keeping the instrument submerged in the water, with a brush, apply CE marked cleaning solution to all surfaces. Pay particular attention to serrations, teeth, ratchets and hinges, always brushing away from the body. Ensure rongeurs and hinged instruments are thoroughly cleaned in both open and closed positions.

Three: Rinse instruments thoroughly with clean water, so that the water reaches all parts of the instrument, then carefully hand dry or use an industrial drying cabinet.

Note: when manual cleaning is used it may not be possible to disinfect the device prior to further handling.
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.
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