Zimmer Biomet
1.0/1.5MM SYSTEM
Recommendations for the Care and Handling Biomet Microfixation Non-sterile, Non-powered Reusable Instruments and Instrument Cases
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Revision: B DATE: 2021/05
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01-50-1680 EN Rev. B Recommendations for the Care and Handling Biomet Microfixation Non-sterile, Non-powered Reusable Instruments and Instrument Cases
Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA Tel (904)-741-4400 FAX (904)-741-4500
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INSPECTION AND FUNCTIONAL TESTING • Carefully inspect each device to ensure that all visible blood and debris has been removed. • Check the action of moving parts (when applicable) to ensure smooth operation through the intended range of motion. • Check instruments with long, slender features (particularly rotating instruments) for distortion. • Where instruments form part of an assembly, check that the devices assemble readily with mating components. • For more information on detecting wear and damage to reusable instruments, see the Reusable Instrument Lifespan Manual 01-50-1690.
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holes, mated surfaces, and other features. Do not clean soiled instruments while in polymer or metal trays. Surgical instruments are subject to wear with normal usage. Always ensure the system instruments are in proper working order prior to surgical use. It is recommended that all instruments be regularly inspected for wear, disfigurement, and breakage prior to each use. Failure to regularly inspect instruments prior to use may result in injury to the patient or user, or damage to the implants. Do not use instruments that are worn or broken. Do not use cutting/sharp instruments with dull or deformed edges or instruments that are deformed, corroded, damaged or worn. They may not perform as intended. Do not subject instruments to high loads and/or impact as breakage can occur.
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Recommendations for the Care and Handling Biomet Microfixation Non-sterile, Non-powered Reusable Instruments and Instrument Cases DESCRIPTION Biomet Microfixation manufactures and/or distributes a variety of surgical instruments and instrument cases intended to aid licensed practitioners in performing surgical or dental procedures. These instruments are designed to perform specific functions such as, but not limited to, cutting, grasping, clamping, dissecting, probing, retracting, elevating, or suturing. Surgical instruments may also be used to facilitate the insertion of surgical implants. The clinical benefits of the instruments are primarily to facilitate surgical access, alignment, sizing, positioning, and explantation of the associated implants. These devices are intended to be used in professional healthcare facilities. Before using an instrument placed on the market by Biomet Microfixation, the operating surgeon, healthcare professionals and sterile processing staff should study carefully the following recommendations, warnings, and instructions, as well as the available instrument specific information such as product literature, surgical technique (when available), and the Reusable Instrument Lifespan Manual (01-50-1690). Instrument cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays and/or holders. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing a cleaning, sterilization and drying cycle that has been validated by the user for the equipment and procedures employed at the user facility. INSTRUCTIONS FOR INSTRUMENTS MADE WITH THE FOLLOWING MATERIALS Aluminum, Stainless Steel, Titanium, Polymeric Materials WARNINGS AND PRECAUTIONS • When handling sharp instruments, use extreme caution to avoid injury. • Avoid undue stress or strain when handling or cleaning instruments. • Wear protective gloves and goggles during cleaning and consult with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact. • Unless otherwise indicated, instruments are NOT STERILE and must be thoroughly cleaned and sterilized prior to use. Instruments that are not clean may not be effectively sterilized. • Non-sterile provided instruments are to be stored in the appropriate packaging that protects the instruments from damage or in an appropriate instrument tray. Instruments must be examined for possible damage before use • Automated cleaning using a washer/disinfector alone may not be effective for complex instruments with lumens, cannulations, blind
If damage or wear that may compromise the function of the instrument is noted, do not use the device and contact your representative or the manufacturer. CLEANING AND STERILIZATION Single-use implants and single-use instruments are for single use only and are not reusable. Single-use implants and single-use instruments that have contacted blood, bone, tissue, or other bodily fluids – even if the device was not used – must not be reprocessed and must be discarded. Single-use implants and single-use instruments must be cleaned separately from soiled instruments. The health care facility is responsible to ensure that conditions essential to safe handling and cleaning/disinfection can be achieved. Cleaning should be performed by trained medical personnel. Cleaning agents with low foaming surfactants should be used during manual cleaning procedures to ensure that instruments are visible in the cleaning solution. Manual scrubbing with brushes should always be performed with the instrument below the surface of the cleaning solution to prevent generation of aerosols and splashing which may spread contaminants. Cleaning agents must be completely rinsed from device surfaces to prevent accumulation of detergent residue. Surgical instruments and instrument cases are susceptible to damage for a variety of reasons including the following: prolonged use; misuse; and rough or improper handling. Care must be taken to avoid compromising the performance of the surgical instruments and instrument cases. To minimize damage and risk of injury, the following should be done: • Inspect the instrument case and instruments for damage upon receipt and after each use and cleaning. Do not use damaged instruments or instrument cases. • Only use an instrument for its intended purpose. • When handling sharp instruments, use extreme caution to avoid injury. • Alkaline detergents with a pH ≤ 12 may be used to clean stainless steel and polymer instruments; however, it is critical that alkaline cleaning agents are thoroughly neutralized and rinsed from instruments prior to sterilization. The use of alkaline cleaning agents might be corrosive to the surface of aluminum and titanium instruments and produce cosmetic defects in the instruments. Drill bits, reamers, rasps and other cutting instruments should be carefully inspected after processing with alkaline detergents to ensure that cutting edges are fit for use. • Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of the instruments. Soft-bristled, nylon brushes and pipe cleaners should be used.
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Do not stack instruments or place heavy instruments on top of delicate 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. Descaling agents that include morpholine should not be used in steam sterilizers. These agents leave residue which can damage polymer instruments over time. Steam Sterilizers should be descaled in accordance with the manufacturer’s instructions. Polymers used in instrument sets can be sterilized using steam/moist heat. Polymer materials have a limited useful life. If polymer surfaces turn “chalky,” show excessive surface damage (e.g. crazing or delamination), or shows excessive distortion or is visibly warped, the instrument should be replaced. Most currently available polymers will not withstand conditions in washers/sterilizers that operate at temperatures equal to or greater than 141°C / 285°F, and use live-stream jets as cleaning features. Severe surface damage to polymer instruments may occur under these conditions. Stainless steel instruments may be treated with rust removal agents approved for surgical instruments if needed. Titanium and titanium alloy devices are especially susceptible to discoloration from steam impurities and detergent residues which form multi-colored surface layers of oxide deposits. Upon repeated sterilization, these oxide layers, while not harmful to the patient, may become dark and obscure graduation marks, item and lot numbers, and other stamped or etched information. Acidic, anti-corrosion agents may be used to remove this discoloration as needed. Use of hard water should be avoided. Softened tap water may be used for initial rinsing. Deionized (DI) water should be used for final rinsing to eliminate mineral deposits on instruments.
Cleaning and Disinfection A. Point-of-Use Preparation for Reprocessing Remove excess body fluids and tissue from instruments with a disposable, non-shedding wipe. Place instruments in a basin of distilled water or in a tray covered with damp towels. DO NOT allow saline, blood, body fluids, tissue, bone fragments, or other organic debris to dry on instruments prior to cleaning. Note: Soaking in proteolytic enzyme solutions or other pre-cleaning solutions facilitates cleaning, especially in instruments with complex features and hard-to-reach areas (e.g. cannulated and tubular designs, etc). These enzymatic solutions as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based materials from drying on instruments. Manufacturer’s instructions for preparation and use of the solutions should be explicitly followed. For optimal results, instruments should be cleaned within 30 minutes of use or after removal from solution to minimize the potential for drying prior to cleaning. Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk. Do not place soiled instruments back into the instrument case. B. Preparation Before Cleaning Where applicable, multi-component instruments should be disassembled for appropriate cleaning. Care should be exercised to avoid losing small screws and components. C. Preparation of Cleaning Agents Neutral pH, enzymatic, and alkaline cleaning agents with low foaming surfactants are recommended. Alkaline agents with pH ≤ 12 may be used in countries where required by law or local ordinance. Alkaline agents should be followed with a neutralizer and/or thorough rinsing. Only agents with proven efficacy (VAH listed, or CE marked, where applicable) should be used. As a large variety of cleaning agents and disinfectants exists around the globe, no specific brand is recommended. It is important to select enzymatic solutions intended for breakdown of blood, body fluids, and tissues. D. Combination Cleaning and Disinfection Instructions 1. Completely submerge the instruments in an enzyme or alkaline (pH ≤ 12) solution and allow to soak and sonicate for 10 minutes at 40-50 kHz. If using enzymatic cleaning agents,
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use a soft nylon bristled brush to gently scrub the instrument until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors, and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). Use of a syringe or water jet will improve flushing of difficult to reach areas and closely mated surfaces. Remove instruments from the cleaning solution and rinse in deionized (DI) water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes, and other difficult-to-reach areas. Place instruments in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle. Do not clean instruments inside of provided instrument case (where applicable), this may result in stacked instruments not properly cleaned and disinfected. The minimum parameters in Tables 1 and 2 are essential for thorough cleaning and disinfection. Table 1 – Typical U.S. Automated Washer/Disinfector Cycle for Surgical Instruments Step Description 1 2 minute prewash with cold tap water 2 20 second enzyme spray with hot tap water 3 1 minute enzyme soak 4 15 second cold tap water rinse (twice) 5 2 minute detergent wash with hot tap water (64-66°C / 146-150°F) 6 15 second hot tap water rinse 7 2 minute thermal rinse (80-93°C / 176200°F) 8 10 second deionized (DI) water rinse with optional lubricant (64-66°C / 146-150°F) 9 7 to 30 minute hot air dry (110°C / 240°F) Table 2 – Typical European Automated Washer/Disinfector Cycle for Surgical Instruments Step Description 1 5 minute pre-rinse with cold tap water 2 10 minute alkaline cleaning agent wash at 55°C 3 2 minute rinse with neutralizer 4 1 minute rinse with cold tap water 5 Disinfection at 93°C with hot deionized (DI) water until A0 3000 is reached (approximately 10 minutes) 6 40 minute hot air drying at 110°C
Sterile Packaging • 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. A. Packaging of Individual Devices • Single devices should be packaged in a medical-grade sterilization pouch or wrap which conforms to the recommended specifications for steam sterilization provided in Table 3. Ensure that the pouch or wrap is large enough to contain the device without stressing the seals or tearing the pouch or wrap. • The sterilization wrap used should be FDA cleared, where geographically applicable. B. Packaging Instrument Sets in Trays and Cases with Lids • If an instrument case is provided with the system, implants and instruments may be loaded into their designated locations for sterilization (as applicable). The lid should be secured tightly. If the lid does not close properly, ensure the devices are placed in their
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appropriate locations and that the instrument case is not over-loaded. Trays and cases with lids must be wrapped in standard medical grade, steam sterilization wrap using the double-wrap method or equivalent. The sterilization wrap should be FDA cleared, where geographically applicable. Do not sterilize in rigid sterilization containers (such as Aesculap® Trays) as devices may not be properly sterilized.
Sterilization • Flash (immediate-use) steam sterilization is not recommended. • Steam sterilizer manufacturer recommendations should always be followed. When steam sterilizing multiple instrument sets in one sterilization cycle, ensure that the manufacturer’s maximum load is not exceeded. • See Table 3 for recommended minimum steam sterilization parameters in the United States that have been validated to provide 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 the table. Table 3 – Recommended Steam Sterilization Parameters for the United States Cycle Type
Temperature
Exposure Time
Minimum Dry Time1
Minimum Cool Time2
U.S. 132°C / 4 30 30 Prevacuum 270°F Minutes Minutes Minutes 1Drying times vary according to load size and should be increased for larger loads. 2 Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. •
of tampering, or has been exposed to moisture, the instrument set must be cleaned, repackaged, and sterilized. Note to US Customers: FDA cleared sterilizers and wraps are to be used in the sterilization process. DISPOSAL INFORMATION When disposing of an instrument, it is a potential biohazard, since it may be contaminated with blood or other body fluids, bone or other tissue. Handle and dispose this product in accordance with accepted medical practice and with applicable local, state and national laws and regulations. REPORTING PROBLEMS The user and/or patient should report any suspected serious incident related to the device by informing the manufacturer and the competent authority of the member state (where applicable) in which the serious incident has occurred.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician, dentist, or properly licensed practitioner. Operating Surgeons and all personnel involved with handling these products are responsible for attaining appropriate education and training within the scope of the activities which they are involved in the handling and use of this product. All trademarks herein are the property of Zimmer Biomet or one of its subsidiaries unless otherwise indicated. The CE Mark is valid only if it is also printed on the product label.
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See Table 4 for recommended minimum steam sterilization parameters outside the United States that have been validated to provide 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 the table. Table 4 – Recommended Steam Sterilization Parameters for Outside the United States Cycle Type
Temperature
Exposure Time
Minimum Dry Time1
Minimum Cool Time2
U.K. Prevacuum Prevacuum
134°C / 3 30 30 273°F Minutes Minutes Minutes 134°C / 18 30 30 3,4 273°F Minutes Minutes Minutes 1Drying times vary according to load size and should be increased for larger loads. 2Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. 3Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination. 4 This cycle is not to be used for the inactivation of prions.
Storage and Shelf Life • Sterile, packaged devices 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. • Care must be exercised to prevent damage to the sterile barrier. • The health care facility should establish a shelf life for sterilized devices based on the type of sterile wrap used and the recommendations of the sterile wrap manufacturer. • Sterile device packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. If a sterile wrap is torn, perforated, shows an evidence Page 3 of 3
Manufacturer Date of Manufacture Caution Catalogue Number Batch Code Federal Law (USA) restricts this device to sale by or on the order of a physician, dentist or properly licensed practitioner. Authorized Representative in the European Community Importer Medical Device Consult Instructions for Use http://labeling.zimmerbiomet.com Non-sterile