HS JOHN WEISS
Reusable Microsurgical Instruments Care, Maintenance and Reprocessing Guidelines
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Care, Maintenance & Reprocessing Guidelines for Reusable Microsurgical Instruments Symbols Caution consult document for important safety related information Consult instructions for use Manufacturer This product complies with medical device directive (93/42/EEC) Batch code
New Instruments New reusable surgical instruments are delivered non-sterile. It is necessary to clean and sterilise them in accordance with the instructions provided before use. • • • • •
The care of delicate surgical instruments starts on delivery. John Weiss makes every effort to supply you with perfect instruments. Carefully remove them from their boxes and examine them under magnification to be assured they are in perfect condition. If a problem is found, notify John Weiss immediately (see additional information for contact details). Once the instrument has been examined and accepted it should be cleaned before placing it in the sterilising tray.
Warnings • •
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Protective caps provided with instruments are not suitable for high temperatures and must be removed before sterilisation. Vitreoretinal instruments, diamond knives & other specialist instruments such as the Weiss IOL Cutters require special attention. Please refer to the separate guidelines for these. Please note that silver products such as some cannula and lacrimal probes are subject to tarnishing and discolouration. This will in no way affect the performance of the instrument
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Devices with long or narrow lumen, hinges, blind holes and lumen require particular attention during cleaning. Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used. Wherever possible avoid acids and harsh, abrasive agents. Instruments must be used for their specified purpose. Incorrect use could damage the instrument. Our instruments are designed for use by surgeons, who have a full understanding of their features and how they should be used. Any other use can compromise the safety of the user and the patient. It is the responsibility of the surgeon to choose the suitable instrument for the surgical technique being performed, based on their experience and expertise. Note: When reprocessing medical devices, always handle with care, wearing protective clothing, gloves and eyewear in accordance with Health & Safety Procedures.
Limitations on Reprocessing • •
Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage in use.
Cleaning (Theatre) • •
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Immediately after each procedure, all instruments should be cleaned to prevent the drying of impurities on the instruments. Demineralised / sterile water should be used. Cannula, suction tubes and other instruments with a lumen (e.g. Vitreoretinal instruments) should be flushed through immediately after use (see separate guidelines for Vitreoretinal instruments & Weiss IOL Cutters). De-mineralised / sterile water used for flushing should be cool to avoid coagulation of proteinaceous material. Diamond knives require particular care. Please refer to the separate guidelines for these instruments.
Cleaning (SSD/HSDU/CSSD/TSSU) •
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Immediately after each procedure, all instruments in the surgical tray should be wiped clean. A John Weiss sterile instrument wipe moistened in demineralised/sterile water is recommended. Ultrasonic cleaning for 5–10 minutes with a neutral pH ultrasonic cleaning solution is recommended. All cannulated instruments (e.g. Vitreoretinal instruments) must be ultrasonically cleaned or brushed through with an appropriate cleaning brush. Instruments must be completely free of moisture before sterilisation.
Washer Disinfectors (Decontamination) •
Mechanical machine washing (with the exception of the open style tunnel washer) is suitable for almost all ophthalmic instruments.
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Use only CE marked or validated washer disinfector machines and low foaming, non ionising cleaning agents and neutral detergents (pH less than 10.5). Follow the manufacturer’s instructions for use, warnings, concentrations and recommended cycles. A neutral detergent is preferred with a value of <pH10.5. The washer disinfector should comply with HTM 01 01 Part D or the equivalent guidance document in your unit / hospital. Final rinse should be with RO (reverse osmosis) quality water. Instruments should be secured in recommended John Weiss ophthalmic trays with silicone matting or holders to prevent movement. When drying is achieved as part of a washer disinfector cycle, do not exceed 120°C. Where appropriate, use suitable attachments to flush inside cannula and devices with a lumen.
Cleaning Inspection • After cleaning, visually inspect all surfaces, cannulations, ratchets, joints, holes and lumen for complete removal of soil and fluids. If any soil or fluids is still visible, return the instruments for repeat decontamination.
Maintenance and Care •
Apply a small amount of surgical grade lubricant to hinges, joints and moving parts to prevent staining, corrosion and wear.
Inspection • • •
All instruments in the tray should be checked for damage or malfunction after each procedure, whether or not they were used. Use of an appropriate microscope is recommended due to the delicate and precise nature of the instruments. Any damaged or worn instruments must be removed from the tray at this stage. These instruments may be returned to John Weiss for repair.
Packaging •
Instruments should be secured in recommended John Weiss ophthalmic trays with silicone matting or holders to prevent movement. Ensure that cutting edges are protected. Care should be taken that instruments do not touch one another when secured. Wrap trays using appropriate method.
Sterilisation • • • •
Only sterilise a clean instrument. The preferred method of sterilisation is moist heat in an autoclave at a temperature of 134-137°C for a minimum holding time of 3 minutes and dried for a further 20 minutes. Follow the guidelines in HTM 01 01 Part C or the equivalent guidance document in your unit/hospital. For effective steam penetration, use perforated ophthalmic trays and open all ratchets and locks on the instruments.
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Instruments should not be taken from the Sterile Services Department until properly cooled down, as rapid lowering of temperature will cause condensation and may cause corrosion. Instruments must be completely free of moisture before storage.
Alternative Processing Methods John Weiss understands that with the introduction of new and alternative processing methods, new cleaning and decontamination materials become available in which clinical institutions may consider changing to for commercial or regulatory reasons. It is the responsibility of the clinical institution to ensure that the alternative materials and methods are assessed for suitability before implementation.
Storage •
Ensure instruments are dry before storage, and stored in a dry, clean condition.
Additional Information •
These guidelines should be read in conjunction with:
HTM 01 01 on sterilisation* HTM 01 01 Part D on washer disinfectors*
*Consult the equivalent guidance documentation for your unit / hospital.
General • • •
Please contact John Weiss on +44 (0)1908 340000 for further advice concerning the care of your microsurgical instruments and our expert repair service. To protect your valuable investment, ask us about our full range of instrument trays. Please note that all John Weiss products are latex free.
The instructions provided above have been validated in accordance with ISO 17664 as being capable of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing is performed using the equipment, materials and personnel in the processing facility to achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. John Weiss & Son Ltd 23 Shenley Pavilions, Chalkdell Drive Shenley Wood, Milton Keynes MK5 6LB, UK Tel: +44 (0)1908 340000 Fax: +44 (0)1908 340014 Email: [email protected]
JW2015/598
Issue 3
27 Apr 2018