Cleaning Swann-Morton Skin Graft Handles

Care, Handling and Reprocessing of Swann-Morton Skin Graft Knife Handles

Surgical instruments are designed to perform many specific functions. The use of any instrument for tasks other than those for which they are intended may result in damage or breakage. The proper cleaning, handling and sterilisation procedures will ensure that your surgical instrument will perform as intended and extend its useful life.

How Supplied

The instrument is supplied non sterile and must be cleaned and sterilised prior to use according to the procedures outlined in this document, unless stated otherwise with the packaging of the product.

Inspection & Function Testing

Visually inspect and check the instrument for damage and wear; 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. Remove for repair or replacement any worn out, fractured or damaged instruments.

Precautions

Delicate surgical instruments require special handling to prevent damaging. Use caution during cleaning and sterilisation. A non fibrous sponge should be used to wipe off all blood and surgical debris. Do not apply excessive stress or strain to the joints, misuse will result in damage. Do not apply excessive stress during use. Instruments manufactured of different metals should be processed separately to avoid electrolytic action between the different metals.

Care & Handling

The procedures outlined below are recommended to ensure safe handling of biologically contaminated surgical instruments. All instruments must be sterilised before use. NOTE: When reprocessing medical devices always follow local Health & Safety procedures.

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 140 degrees C. Some sensitive materials can be damaged by higher alkaline solutions, (pH >10). Devices with long hinges and blind holes require particular attention during cleaning. Note: Single use devices must not be reprocessed and reused.

Limitations on Reprocessing

Repeated processing has minimal effect on stainless steel surgical instruments. End of life is normally determined by wear and damage in use.

1. Pre - Cleaning

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 as soon as it is reasonably practical following use. If they cannot be reprocessed immediately, use an enzymatic cleaner to help prevent soil from drying.

2. Cleaning (Cleaning Precautions)

Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus, blood or other bodily fluids. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents.

Assembling

In order for the hand-operated dermatome/skin graft knife to function properly, pressure must be evenly distributed over the entire length of the blade. This can be achieved only if the procedure described below is applied.

* In order to avoid damaging the blade, set the guide rod so that it is as far away as possible from the blade.

* Insert the blade precisely in the mounting that is provided for it.

* Fix the blade in place with the tensioning plate.

Disassembling

WARNING Risk of injury from sharp blade!

* Remove blade carefully.

* Avoid damaging the edges of either the base plate or tensioning plate.

* Do not use hard or metallic objects to remove the blade.

* Discard Blade in used sharps container.

Care and Handling

After each use

* Clean contaminated instrument as soon as possible.

* For mechanical cleaning, place the instrument in a suitable wire basket, and avoid watermarks.

* Preferably put away the instrument when it is dry.

* If put away while wet, use an active cleaning disinfectant. Prior to mechanical cleaning and disinfecting, rinse the instrument thoroughly in clear running water.

* If ultrasound is needed, carry out the procedure according to the instructions provided by the manufacturer of the apparatus:

- as an effective mechanical supplement to manual cleaning.

- for initial cleaning of instruments with dried debris on them prior to mechanical cleaning.

- Perform manual or mechanical cleaning. Follow the manufacturer's instructions.

Manual Cleaning, Disinfecting

* Place the instruments in a suitable active cleaning disinfectant solution in such a way that all surfaces, interior surfaces, lumina, and openings are immersed. Follow the disinfectant manufacturer's instructions.

* After disinfecting chemically, always rinse the items thoroughly in plenty of clear running water. Follow the disinfectant manufacturer's instructions.

* Remove encrusted material with a soft nylon brush. Do not use harsh cleaning agents or metal brushes.

* Dry lumina and channels with a soft round nylon brush of the appropriate diameter.

* Carry out the final rinse in distilled or fully demineralized water.

* Dry the instrument with a soft, absorbent, lint-free cloth.

* Dry lumina and channels with compressed air.

Mechanical Cleaning, Disinfecting

* When choosing a program, take into consideration the type of material (e.g. stainless instrument-grade steel, aluminum) the instruments being cleaned are made of. Follow the instructions provided by the manufacturer of the cleaning device.

* Carry out the final rinse in fully demineralized water.

* Be sure the drying phase is sufficiently long.

* Remove the instrument from the apparatus as soon as the program is completed.

Control

* Allow the instrument to cool down to room temperature.

* Spray moving parts such as hinges and latches with a sterilizable and moisture-permeable lightweight machine oil.

* Inspect the instrument after each cleaning and disinfecting cycle to be sure it is clean, functioning properly, not damaged and does not have e.g. any loose, bent, broken, cracked, worn, or fractured components.

* Set aside and replace the instrument if it is damaged or defective.

Sterilization Method and Parameters

* Sterilize using steam sterilization, taking note of the following:

The sterilization has to be done according to a validated steam sterilization procedure (e.g. in a sterilizer according to EN 285). In case of application of the fractionated vacuum procedure the sterilization has to be carried out for a minimum of 5 minutes at 134°C and at 2 bar pressure.

Sterilization for the U.S market

* Sterilization of the device may be accomplished by steam or ethylene oxide (EtO) gas.

* SWANN-MORTON does not recommend the device be sterilized by Flash or chemical sterilization.

* Surgical instruments may also be placed with-in a rigid sterilization container (sterile - container) for processing under generally accepted hospital in-house conditions.

The recommended sterilization parameters are as follows:

Sterilization Method	Temp.	Minimum exposure time
Sterilization Method	Temp.	Wrapped	In a sterile container system
Pre-vacuum	270 - 275 °F	4 min	4 min
Gravity	250 - 254 °F	15 min	40 min
Gravity	270 - 275 °F	10 min	30 min
Ethylene Oxide (EtO)	125 - 130 °F	105 min with 12 % EO, 88% FREON; 45-75% chamber humidity, reaction of 6 hours

3. Lubrication / Assembly / Inspection

Special attention should be given to the lubrication of joints and moveable parts. Do not use mineral oil, petroleum or silicone based products. To lubricate joints use a non silicone water soluble lubricant prior to sterilisation.Mechanically test the working parts to verify that each instrument performs correctly.

Visually inspect and check: all instruments for damage and wear; 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. Remove for repair or replacement any worn out, flaking, fractured or damaged instruments.

Note: If a product is returned, the instrument must be decontaminated and sterilised and be accompanied with the relevant documented evidence.

Note: Instruments must be in the unstressed condition before sterilisation to avoid temperature induced stress cracks in the joints.

Note: All instruments to be packed following local protocol in accordance with any relevant Standards.

4. 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 prior to sterilisation.

5. Storage

Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.

6. Additional Information

Cleaning and sterilising guidelines are available in HTM 2030, HTM 2010, BS EN ISO 17665-1 (from all good stationery offices) and ABHI, Report on the Validation of a Reprocessing Instruction Template for Generic Class I Medical Devices (Ref: SI SIS 0038). An invitation to subscribe can be viewed and printed by clicking here.

NOTE: IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT, MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO 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.

WE DO NOT RECOMMEND THAT SKIN GRAFT KNIFE HANDLES ARE DISASSEMBLED DUE TO THE NATURE OF THEIR MANUFACTURE.

Returning handles to the Manufacturer

Products returned to Swann-Morton must have a decontamination certificate, which testifies that each instrument has been thoroughly cleaned and disinfected. Failure to supply evidence of cleaning and disinfection will result in the delay of your enquiry being processed.