Insturment Care

Instruments Care & Handling

Instructions for Reprocessing of Reusable Surgical Instruments

The following instructions are for all reusable medical devices supplied by us, 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.

Warnings

·        Follow instructions and warnings as issued by the manufacturers of any decontaminants, disinfectants and cleaning agents. 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. Aluminum) are damaged by high alkaline solutions (pH>10).

·        Devices with long, narrow canola, hinges and blind holes require particular attention during cleaning.

Note: When reprocessing medical devices, always handle with care, wearing protective clothing, gloves and eye-wear in accordance with local health & safety procedures.

 Limitations on Reprocessing

·        Repeated processing has minimal effect on these instruments.

·        End of life normally determined by wear and damage in use.

·        Any specific limitations on the number of reprocessing cycles shall be made available with instrument.

 From Point of Use

·        Whenever 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 to help prevent soil from drying.

Cleaning: Automated

·        Use only either CE marked or validated washer-disinfector machines and low foaming, non-ionizing cleaning agents and detergents.

·        Load instruments carefully, with any box joints and hinges open and so that any fenestration in instruments can drain.

·        Place heavy instruments with care in the bottom of containers and not to overload wash baskets.

·        Where possible, use appropriate attachments to flush inside reamers and devices with lumens or canola.

·        Ensure that soft, high purity water which is controlled for bacterial endo toxins is used in the final rinse stage.

Note:  Automated cleaning may not be suitable for all lumens and canola in which case clean manually with a water jet gun, if available and an appropriate brush (and stiletto if provided) that reaches the depth of the feature. After manually cleaning pass all devices through an automatic cleaning cycle to achieve disinfection.

Manual Cleaning

·        Manual cleaning is not advised if an automatic washer-disinfector is available. If the 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 of the re-processor 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 re-processor from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences.

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 with soft high pure water which is controlled for bacterial endo toxins so that the water reaches all parts of the instrument, then carefully hand dry or use a drying cabinet.

Cleaning Inspection

·        After cleaning visually inspect to all surface of canola’s, 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.

Inspection and Functional Testing

·        Check all instruments for damage and wear; cutting edges are free from 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 and 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 sterilized and be accompanied with the relevant documented evidence. 

Sterilization (USA)

·        Autoclave should comply with the requirements of, and be validated and maintained in accordance with ANSI/AAMI ST79.

·        Pre-Vacuum moist heat sterilization operating at temperature 132 °C bar for a minimum holding time of 4 minutes – always following the instructions of the machine manufacturer.

·        When sterilizing multiple instruments in one autoclave cycle, ensure that the sterilizer manufacturers stated maximum load is not exceeded.

·        Ensure instruments are dry before sterilization.

Sterilization (In other Countries)

·        Autoclave should comply with the requirements of, and be validated and maintained in accordance with EN 285, EN 13060, EN ISO 17665.

·        Either CE marked or validated vacuum autoclave operating at 134-137 °C bar for a minimum holding time of 3 minutes – always following the instructions of the machine manufacturer.

·        When sterilizing multiple instruments in one autoclave cycle, ensure that the sterilizer manufacturers stated maximum load is not exceeded.

CLEANING:

All blood dried body fluids should be completely removed from the instruments prior to sterilization. Several methods are available.

  1. Soak: An enzymatic cleaner bath (soak) or a solution of water and neutral pH (7) detergent are effective in removing organic material from instruments. Use distilled water if possible. Instruments should be fully submerged for at least 10 minutes. Do not use running water to remove solution from let “sharp” (scissors, knives, osteotomes, etc.). Change solutions frequently.
  2. Ultrasonic Cleaning: Most instruments manufacturers recommend ultrasonic cleaning as the most effective way to clean surgical instruments, particularly those with hinges, box locks and other moving parts. All instruments must be fully submerged in open position. Make sure that “sharp” blades not touch other instruments to prevent possible surface scratching and also be sure dissimilar metal instruments are separated. Process instruments for full recommended ultrasonic cleaning cycle. Change solution frequently. Rinse instruments with water to remove the cleaning solution, can be safe use with all ultrasonic unites.

CAUTION:

Ø  Use stiff nylon cleaning brushes. Do not use steel wool or wire brushes except specially recommended stainless steel wire brushes for instruments serrated areas, bone or on stained areas of knurled handles.

Ø  Use only neutral (pH 7) detergents. If not rinsed off properly, low pH (acidic – less than pH 6) detergents break down the stainless protective surface resulting in pitting and/or back staining. High pH detergents (alkaline – more than pH 8) which can also interfere with the smooth operation of instruments. Most of the brown stains are not rust and are easily removed with stain remover.

Ø  Brush delicate instruments carefully and if possible separate them from general instruments.

Ø  Make sure instruments surfaces are visibly clean and free from stain and tissue. Stain Remover can help remove residue stains. This is also a good time to inspect each instrument for proper function and condition.

Ø  Check scissors’ blades to ensure proper function. Blades should glide open and closed smoothly. Test cutting performance at ¾ length of the blade with the following recommended materials. Scissors should cut all the tips. Recommended cutting test materials:

Ø  Suction tube should be clean inside.

Ø  Retractors should function properly.

Ø  Cutting edge instruments and knives should be sharp and free of damage.

Ø  After scrubbing, rinse instruments thoroughly under running water. While rinsing, open and close scissors, hemostats, needle holder and other hinged instruments to make sure the hinge areas are rinsed out and no debris remain.

AFTER CLEANING:

Separate dissimilar metals prior to sterilizing/autoclaving. If instruments are stored, let them in clean and dry environment at room temperature.

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