PS3003-01 Instrument Care, Cleaning and Sterilisation Instructions

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USER GUIDE

INSTRUMENT CARE, CLEANING & STERILISATION INSTRUCTIONS Key to the symbols on the labelling: Parts Supplied Non-Sterile Manufacturer Product complies with requirements of directive 93/42/EEC for European Union Class I medical devices Product complies with requirements of directive 93/42/EEC for European Union Class Im & IIa medical devices Authorised European Representative INSTRUMENTATION OVERVIEW  Global Manufacturing Technology (GMT) instrumentation consists of medical devices used in orthopaedic surgical procedures. The range includes surgical instruments from Class I to Class IIa (as per 93/42/EEC Directive). The instruments are detailed in the Surgical Technique booklet.  GMT instruments must only be used by qualified personnel trained in the use of the surgical instruments and the relevant surgical procedures.  Limits of accuracy of all GMT instrumentation is ±0.5mm unless otherwise stated. INSTRUMENTATION USE  The Surgical Technique booklet must be thoroughly read and understood by the surgeon. This booklet details the use of each individual instrument in relation to the surgical procedure.  Before clinical use, the surgeon must thoroughly understand all aspects of the surgical procedure and the limitations of the instrumentation. Be aware of patients that may have sensitivities or allergies to stainless steel metals and polymer materials.  The Global Instruments are surgically invasive orthopaedic medical devices intended for transient use in the surgical environment.  Instruments are to only be used by trained and qualified surgical and theatre staff.  Non-metallic components such as polymer or rubber materials may not be observable in-vivo using external imaging devices.

PS3003-01 REV 11

PRODUCT HANDLING  This guide covers all GMT reusable instruments and should be studied carefully.  All GMT reusable instruments may be safely and efficiently reprocessed using the instructions outlined in this guide.  The user/processor should comply with local laws and ordinances in countries where reprocessing requirements are more stringent than those detailed in this guide.  New and used instruments must be thoroughly processed according to these instructions prior to use. WARNINGS & PRECAUTIONS  Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges.  Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers.  Do not place heavy instruments on top of delicate devices.  Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of instruments. Soft-bristled, nylon brushes and pipe cleaners should be used.  Do not allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and sterilisation steps are facilitated by not allowing blood, body fluid, bone and tissue debris, saline, or disinfectants to dry on used devices.  Saline and cleaning/disinfection agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and should not be used. Instruments must not be placed or soaked in Ringers Solution.  Mineral oil or silicone lubricants should not be used because they coat microorganisms, prevent direct contact of the surface with steam and are difficult to remove. LIMITATIONS & RESTRICTIONS  Automated cleaning using a washer/disinfector alone may not be effective for orthopaedic instruments. A thorough, manual cleaning process has been validated and is recommended.  Neutral pH enzymatic and cleaning agents are recommended and preferred for cleaning GMT reusable devices.  Instruments must be removed from metal or polymer trays for manual cleaning. Instrument trays, cases and lids must be cleaned separately. Non-sterile, single-use plate and screw implants are an exception to this rule. Plates and screws may remain in the tray or caddy for reprocessing. Where indicated on instrument tray checklists, devices must be sterilised in the individually wrapped configuration.  Repeated processing, according to the instructions in this manual has minimal affect on GMT reusable manual instruments unless otherwise noted. End of life for stainless steel or other metal surgical instruments is normally determined by wear and damage due to the intended surgical use and not to reprocessing.  Use of hard water should be avoided. Softened tap water may be used for initial rinsing. Purified water should be used for final rinsing to eliminate User Guide - Instrument Care, Cleaning & Sterilisation Instructions

mineral deposits on instruments. One or more of the following processes may be used to purify water: ultra-filter (UF), reverse osmosis (RO), deionised (DI), distilled water, or equivalent.  Ethylene oxide (EO), gas plasma and dry heat sterilisation methods are not recommended for sterilisation of GMT reusable instruments. Steam (moist heat) is the recommended sterilisation method for GMT instruments.

INSTRUCTIONS POINT OF USE  Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk.  Instruments should be cleaned within 30 minutes of use to minimise the potential for drying prior to cleaning.  Flush the instrument in running water, within the temperature range 15°C to 30°C, to remove gross visible blood and body substances. PREPARATION FOR DECONTAMINATION  Symbols or specific instructions etched on instruments or instrument trays and cases should be strictly followed.  Where applicable, multi-component instruments should be disassembled for appropriate cleaning. Disassembly, where necessary is generally selfevident. Care should be exercised to avoid losing small screws and components.  All cleaning agents should be prepared at the use-dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents. Note: Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/or turbid). MANUAL CLEANING & DISINFECTION Description: Enzymatic soak and scrub followed by sonication. Step 1 Completely submerge instruments in enzyme solution and allow to soak for 20 minutes. Scrub using a soft-bristled, nylon brush (crevices, lumens, mated surfaces and other hard to clean areas should be attended) until all visible soil has been removed. Hold the items low in the sink to limit the generation of aerosols during scrubbing. Note: Clean cannulations and holes using an appropriate brush ensuring that the full depth of the feature is reached. Manoeuvre any movable parts repeatedly under running water for a minimum of 1 minute to loosen any trapped debris. Step 2 Remove the device from solution and rinse in purified water (from one or any combination of the following: ultra-filter, reverse osmosis, deionised or distilled) for a minimum of 3 minutes. Thoroughly flush holes and other difficult to reach areas. Ensure that running water passes through the cannulations, and that blind holes are repeatedly filled and emptied. Note: Manoeuvre any movable parts repeatedly under running water for a minimum of 1 minute to loosen any trapped debris.

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