Instructions: Reprocessing Reuseable Devices
Manufacturer: SCALA SURGICAL LTD
Device(s): The following instructions are for all reusable medical devices supplied by Scala Surgical Ltd, 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.
• 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 140° C.
• Some sensitive materials (e.g. Aluminium) are damaged by high alkaline solutions (pH >10).
• Devices with long, narrow cannula, hinges and blind holes require particular attention during cleaning.
Note: when reprocessing medical devices, always handle with care, wearing protective clothing, gloves and eyewear in
accordance with local Health & Safety procedures.
• 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.
• Wherever possible, do not allow blood, debris or bodily fluids to dry on instruments. For best results and to prolong the life of the
medical device reprocess immediately after use. If they cannot be reprocessed immediately, use an enzymatic foam spray cleaner
FROM POINT OF USE
to help prevent soil from drying.
PREPARATION FOR • Reprocess all instruments as soon as it is reasonably practical following use.
DECONTAMINATION • Disassemble only where intended, without the use of tools unless specifically provided by the manufacturer.
• Use only either CE marked or validated washer-disinfector machines and low-foaming, non-ionising cleaning agents and
detergents following the manufacturers' instructions for use, warnings, concentrations 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, taking care not to overload wash baskets.
• Place instruments with concave surfaces facing down to prevent pooling of water.
• Where available, use appropriate attachments to flush inside reamers and devices with lumens or cannula.
• Ensure that soft, high purity water which is controlled for bacterial endotoxins is used in the final rinse stage.
Note: automated cleaning may not be suitable for all lumens and cannula, in which case clean manually with a water jet gun, if
available, and an appropriate brush (and stilette if provided) that reaches the depth of the feature. After manually cleaning, pass all
devices through an automatic cleaning cycle to achieve disinfection.
Note: these instructions have been validated using a washer-disinfector cycle validated to include two cold rinses at <35°C, a detergent
cycle and a rinse cycle both at >50°C, a disinfection cycle operating at a temperature of between 80°C and 95°C for a minimum holding
time of 1 minute (actual holding time in excess of 2 minutes 50 seconds) and a 20 minute drying cycle. The detergent used was a low
foaming, non-ionising spray wash detergent cleaner (max 12 pH) and the rinse aid a neutral pH low foaming, non-ionic surfactant with
• Manual cleaning is not advised if an automatic washer-disinfector is available. If this equipment is not available, use the
following process: 1. Use a double sink system (wash/rinse) dedicated for instrument cleaning (not used for hand washing). Ensure that the water
temperature does not exceed 35° C.
2. In the first sink, keeping the instrument submerged, with an autoclavable brush, apply CE marked cleaning solution to all surfaces
until all soil has been removed. Pay particular attention to serrations, teeth, ratchets and hinges, always brushing away from the
body and avoiding splashing. Ensure rongeurs and hinged instruments are thoroughly cleaned in both open and closed positions.
3. In the second sink, rinse instruments thoroughly with soft, high purity water which is controlled for bacterial endotoxins, so that the
water reaches all parts of the instrument, then carefully hand dry or use a drying cabinet.
Note: Manual cleaning is NOT a disinfection process: when manual cleaning is used it may not be possible to disinfect the device prior
to further handling.
• After cleaning, visually inspect all surfaces, cannulations, ratchets, joints, holes and lumens for complete removal of soil
and fluids. If ANY soil or fluid is still visible, return the instrument for repeat decontamination.
• Apply surgical grade lubricants to hinges, joints and moving parts as per the lubricant manufacturer's instructions.
• 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.
All instruments to be packed following local protocol in accordance with BS standards.
Either CE marked or validated vacuum autoclave operating between 134°C - 137°C at 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
Ensure instruments are dry before sterilisation.
Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.
Other forms of cleaning (i.e. ultrasonic) and sterilisation (i.e. Low temperature steam and Formaldehyde, Ethylene Oxide 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.
Cleaning and sterilising guidelines are available in HTM 2030 and HTM 2010.
See brochure for telephone and address of local representative or telephone 0208 997 0077
NOTE: 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.