ZIMMER

Instrument Care, Cleaning and Sterilization Quick Reference Guide

Quick Reference Guide

2 Pages

• The total weight of a wrapped instrument tray or case should not exceed 11.4kg/25lbs. When placed in a sterilization container with gasketed lid the total sterilization package should not exceed 16kg/35lbs. • Any device capable of disassembly must be disassembled prior to placement in the case. • All devices must be arranged to ensure steam penetration to all instrument surfaces. Instruments should not be stacked or placed in close contact. • The user must ensure that the instrument case is not tipped or the contents shifted once the devices are arranged in the case. Silicon mats may be used to keep devices in place. • Only devices manufactured and/or distributed by Zimmer should be included in Zimmer instrument trays. Zimmer validated reprocessing instructions are not applicable to Zimmer trays that include devices that are not manufactured and/or distributed by Zimmer.  Sterilization • Disinfection is only acceptable as a precursor to full sterilization for reusable surgical instruments. See Table 6 for recommended minimum sterilization parameters that have been validated by Zimmer to provide a 10-6 sterility assurance level (SAL). • The hospital is responsible for in-house procedures for the reassembly, inspection, and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Provisions for protection of any sharp or potentially dangerous areas of the instruments should also be recommended by the hospital. • Moist heat/steam sterilization is the preferred and recommended method for Zimmer orthopaedic instrument sets. • Sterilizer manufacturer recommendations should always be followed. When sterilizing multiple instrument sets in one sterilization cycle, ensure that the manufacturer’s maximum load is not exceeded. • Instrument sets should be properly prepared and packaged in trays and/or cases that will allow steam to penetrate and make direct contract with all surfaces. • Ethylene oxide or gas plasma sterilization methods should not be used unless package inserts for the applicable product specifically provide instructions for sterilization using these methods. • Gravity displacement sterilization cycles are not recommended because cycle times are too long to be practical.  Storage • Sterile, packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature/ humidity extremes.  Hospital Responsibilities for Zimmer Loaner Instruments • Orthopaedic surgical instruments generally have a long service life; however, mishandling or inadequate protection can quickly diminish their life expectancy. Instruments which no longer perform properly because of long use, mishandling, or improper care should be returned to Zimmer to be discarded. Notify your Zimmer representative of any instrument problems. • Loaner sets should undergo all steps of decontamination, cleaning, disinfection, inspection, and terminal sterilization before being returned to Zimmer. Documentation of decontamination should be provided with instruments being returned to Zimmer.  Instrument Care, Cleaning and Sterilization  Table 6. Recommended Steam Sterilization Parameters Cycle Type  2 3  4  Pressure  6  Exposure Time  7  Dry Time  UK Prevacuum  134°C 273°F  3bar 28.5psi  3 minutes  30 minutes  1,3  Prevacuum  132°C 270°F  1.86bar 27psi  4 minutes  30 minutes  3,4  Prevacuum  134°C 273°F  3bar 28.5psi  18 minutes  30 minutes  8  Prevacuum  132°C 270°F  1.86bar 27psi  8 minutes  30 minutes  9  Gravity  1,3  1  Temperature  5  In accordance with ISO 17664  • Additional information is available in Zimmer document 97-5000-170-00 R3 which should be used in conjunction with this Quick Reference Guide. • This guide pertains to all Zimmer reusable instruments and should be studied carefully. This manual supercedes Zimmer and Centerpulse instrument manuals published prior to January 2006. • This guide includes processing instructions for all Zimmer reusable devices including legacy Centerpulse instruments marked with processing category codes [a, a+, b, b+, c]. All Zimmer devices may be safely and efficiently reprocessed using the manual or combination manual/ automated cleaning instructions outlined in this manual. • The user/processor should comply with local laws and ordinances in countries where reprocessing requirements are more stringent than those detailed in this manual. • New and used instruments must be thoroughly processed according to these instructions prior to use.  Not recommended due to excessively long sterilization cycles which are not practical.  Minimum validated steam sterilization time required to achieve a 10-6 sterility assurance level (SAL). Minimum validated steam sterilization temperature required to achieve a 10-6 sterility assurance level (SAL). Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in this table. Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination.  5 6 7 8 9  Quick Reference Guide  Considerations  Sea level AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable. Drying times vary according to load size and should be increased for larger loads. For Universal Instrument Cases without defined load configurations. Gravity cycle parameters are available on request from Customer Service.  Warnings & Precautions  Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly.  Important Notice • The instructions provided in this Quick Reference Guide have been validated by Zimmer as being capable of preparing orthopaedic devices for use. It is the responsibility of the Hospital to ensure that reprocessing is performed using the appropriate equipment and materials, and that personnel in the reprocessing facility have been adequately trained in order to achieve the desired result. Equipment and processes should be validated and routinely monitored. Any deviation by the processor from these instructions should be properly evaluated for effectiveness to avoid potential adverse consequences.  Customer Service Information Address  Telephone  Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580, USA  Inside USA: 1-800-348-2759 Outside USA: Local International Access Code +1-574-367-6131  Zimmer GmbH Sulzer-Allee 8 CH-8404 Winterthur, Switzerland  +41 (0)52 262 60 70  This Zimmer reprocessing manual and the associated Quick Reference Guide can be found at www.zimmer.com under the “Medical Professional” heading.  Page 1 of 2  Contact your Zimmer representative or visit us at www.zimmer.com  97-5000-701-00 5ML Printed in USA ©2006 Zimmer, Inc.  • Trays and cases with lids may be wrapped in standard medical grade, steam sterilization wrap using the AAMI double wrap method or equivalent. • Trays and cases with lids may also be placed in an approved sterilization container with gasketed lid for sterilization. Follow the sterilization container manufacturer’s instructions for inserting and replacing sterilization filters in sterilization containers. Note: Areas designated for specific devices shall contain only devices specifically intended for these areas. Note: These validated reprocessing instructions are not applicable to Zimmer trays that include devices that are not manufactured and/or distributed by Zimmer. Instrument trays and cases without defined, preconfigured layouts or containing undefined universal spaces or compartments should only be used under the following conditions:  • 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 sterilization 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: 1) coat microorganisms; 2) prevent direct contact of the surface with steam; and 3) are difficult to remove. Limitations & Restrictions • Automated cleaning using a washer/disinfector alone may not be effective for orthopaedic instruments. A thorough, manual or combination manual/automated cleaning process is recommended. • Neutral pH enzymatic and cleaning agents are recommended and preferred for cleaning Zimmer reusable devices. Alkaline agents with pH < 12 may be used to clean stainless steel and some polymer instruments in countries where required by law or local ordinance; or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) and Creutzfeldt-Jakob Disease (CJD) are a concern. It is critical that alkaline cleaning agents be completely and thoroughly neutralized and rinsed from devices. Note: Drill bits, reamers, rasps and other cutting devices should be carefully inspected after processing with alkaline detergents to ensure that cutting edges are fit for use. • Instruments must be removed from metal or polymer trays for manual and/or automated cleaning procedures. 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.
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