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Revision C Date: 2021-11-15 © Biomet
01-50-1539 EN Rev. C
Instructions for the Care, Cleaning, Maintenance, Handling, and Sterilization of Biomet Surgical Instruments and Instrument Cases
BIOMET GSCC B.V. Hazeldonk 6530 4836 LD Breda The Netherlands
Biomet Orthopedics
Biomet Trauma
56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA
56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA
Biomet Sports Medicine
Biomet Biologics
56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA
56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA
1AMEN015015391 ENGLISH
EN
Instructions for the Care, Cleaning, Maintenance, Handling, and Sterilization of Biomet Surgical Instruments and Instrument Cases Before using a product placed on the market by Biomet, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available product-specific information (e.g. product literature, written surgical technique). Biomet is not liable for complications that may arise from use of the device in circumstances outside of Biomet’s control including, but not limited to, product selection and deviations from the device’s indicated uses or surgical technique. DESCRIPTION This instruction manual provides information on the care, cleaning, disinfection, maintenance and sterilization of manual surgical instruments. Biomet individual instruments and instrument cases are generally composed of aluminum, stainless steel, and/or polymeric materials. The 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 holders. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow for sterilization of the contents to occur in a steam sterilizer utilizing a cycle that has been validated by the user for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap or rigid container to maintain sterility. This instruction manual is not applicable to air driven or electrically powered equipment. However, it is applicable to functional attachments (e.g. reamers and drill bits) that are connected to powered equipment for use. Unless otherwise specified, rulers and calipers intended to provide a measuring function are accurate within +/- one-half the smallest division on the scale. INTENDED USE: Instruments and instrument cases are intended to: • facilitate implantation of orthopedic medical devices, or • facilitate preparation and application of bone cement to fix orthopedic medical devices to living bone, or • facilitate point of care processing or application of autologous blood and/or bone marrow component(s) or bone graft handling applications. symbol on the package label. Instruments and instrument cases are medical devices and may be identified with the INTENDED USERS: Surgical instruments are intended to be used by: • Surgeons trained to perform orthopedic surgical procedures • Facility central process staff trained to handle, clean, and resterilize surgical devices • Sales representatives who interact with Health Care Professionals and Surgery Center Staff in evaluating, identifying, and/or preparing instruments for surgical procedures INDICATIONS FOR USE AND CONTRAINDICATIONS: Instruments and delivery systems are general accessories used to facilitate: • implantation of orthopedic medical devices, or • preparation and application of bone cement to fix orthopedic medical devices to living bone, or • point of care processing or application of autologous blood and/or bone marrow component(s) or to facilitate bone graft handling. Consequently, indications and contraindications are not applicable for these types of devices. Where used uniquely for a particular implant system, consult that system’s labeling for the detailed indications, contraindications, performance characteristics, and expected clinical benefit for the devices. The clinical benefits of the instruments are primarily to facilitate appropriate alignment, sizing, implantation, and explantation of associated implants. WARNINGS AND PRECAUTIONS • Correct handling of instruments is extremely important. Do not modify instruments. Do not notch or bend instruments. Notches, scratches or other damage and/or wear in the instrument occurring during surgery may contribute to breakage. • Do not reshape or bend instruments in any way. Do not use an instrument that has become bent from its original shape as this will affect the performance of the instrument. Bent instruments should be disposed of. • Do not reuse instruments or devices labeled for single use only. Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents. • Metal instruments or fragments can be located by radiography or fluoroscopy. Nonmetal instruments or fragments may not be located by radiography or fluoroscopy, and should be accounted for at the end of the surgical procedure. • Any decision not to remove broken or fragmented instruments, or a broken drill or drill fragments, is at the surgeon’s discretion and must take into account the associated risks. • The surgeon is to be familiar with the equipment, instruments, surgical technique and surgical procedure prior to performing surgery. • Surgical instruments should only be used for their intended purpose. • Specialized instruments are designed for Biomet® implant systems to aid in the proper implantation of Biomet fixation or prosthetic components. The use of instruments or implant components from other systems can result in inaccurate fit, incorrect sizing, excessive wear and device failure. • Intraoperative fracture or breaking of instruments has been reported for general instruments. • Biomet recommends that all instruments be regularly inspected for wear and disfigurement prior to use. All trial, packaging, and instrument components must be removed prior to closing the surgical site. Do not implant.
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Surgical instruments are subject to wear with normal usage. Instruments with cutting functions or points may become dull with normal use and no longer perform as intended. Inspect prior to use to verify the cutting ability and sharpness of edges. Instruments that have experienced extensive use or excessive force are susceptible to fracture. The patient is to be warned by his/her physician of all surgical risks. Unless otherwise indicated, instruments are NOT STERILE and must be thoroughly cleaned and sterilized prior to use. Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized. Automated cleaning using a washer/disinfector alone may not be effective for complex instruments with lumens, cannulations, blind holes, mated surfaces and other features. Do not clean soiled instruments while in polymer or metal trays. Soaking in disinfectants may be a necessary step to control certain viruses. However, these agents may discolor or corrode instruments (household bleach contains or forms chlorine and chloride in solution and has a corrosive effect similar to saline). Disinfectants containing glutaraldehyde, or other aldehydes may denature protein based contaminants, causing them to harden and making them difficult to remove. Where possible, soaking in disinfectants should be avoided. on the package label) Instruments are for single use only and are not reusable. These devices Single Use (indicated by are single-use but can be reprocessed if not used unless labeling indicates the instrument is not to be reprocessed. Note: not used refers to those single-use components that have not been in contact with blood, bone, tissue, or other body fluids. Any unused, single-use device that has been exposed to blood, bone, tissue, or body fluids must not be reprocessed and must be discarded. Single-use devices must be cleaned separately from soiled instruments. Only devices manufactured and/or distributed by Biomet should be included in Biomet instrument trays and cases. These validated reprocessing instructions are not applicable to Biomet trays and cases that include devices that are not manufactured and/or distributed by Biomet. Ethylene Oxide (EO), Gas Plasma, and Dry Heat sterilization methods are not recommended for sterilization of Biomet devices. The presence of substances greater than a concentration of 0.1% weight/weight which are carcinogenic, mutagenic, symbol. or toxic to reproduction (CMR), or endocrine disruptors (ED), are identified on the product label with the
RESPONSIBILITIES OF THE USER A. Cleaning/Disinfection The health care facility is responsible to ensure that conditions essential to safe handling and cleaning/disinfection can be achieved. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides guidelines for design and personnel considerations, immediate handling of contaminated items and transportation, decontamination processes, servicing, repair, and process performance. Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Care should be taken to avoid penetrating or cutting injuries. 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. 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. See Assembly and Disassembly Manual 1258 for detailed guidelines related to instrument assembling and disassembling, which can be found at: https://www.zimmerbiomet.com/medical-professionals.html. B. Sterilization The health care facility is responsible for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular health care facility. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides guidelines for preparation and assembly, sterilizer loading and unloading, matching the container system to the appropriate sterilization cycle, quality assurance, sterile storage, transport, and aseptic use. C. Complaint and Adverse Event Reporting Any product complaints shall be reported to Zimmer Biomet using the Product Experience Report (Form number CF04001) to [email protected]. Serious adverse events shall also be reported to the Competent Authority of the respective European Union Member State which the event occurred. CARE AND HANDLING OF INSTRUMENTS Surgical instruments and instrument cases are susceptible to damage for a variety of reasons, which includes 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 reviewed: • See Reusable Instrument Lifespan Manual 1219 for guidance on determining reusable instrument suitability for use, which can be found at https://www.zimmerbiomet.com/medical-professionals.html. • Inspect the instruments for damage and completeness upon receipt and after each use and cleaning. Instruments in need of repair should be set aside for repair service or returned to Biomet. Instruments returned to Biomet or its distributors should be cleaned and sterilized prior to shipment. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides guidelines for return, or contact Biomet or your distributor for further instruction. • Only use an instrument for its intended purpose. • When handling sharp instruments, use extreme caution to avoid injury. Consult with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact.
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Alkaline detergents with 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 devices. The use of alkaline cleaning agents might be corrosive to the surface of aluminum and titanium instruments. 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. 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 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 saline or 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. Repeated processing according to these instructions has minimal effect on Biomet 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. Polymers used in Biomet 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 if polymer devices show excessive distortion or are visibly warped, they should be replaced. Notify your Biomet representative if polymer devices need to 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-steam jets as cleaning features. Severe surface damage to polymer devices 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. Purified water should be used for final rinsing to eliminate mineral deposits on instruments.
POSSIBLE ADVERSE EFFECTS Review the package insert of the associated implant system for a list of possible adverse effects that could come from its use CLEANING AND DISINFECTION • Powered devices included in a manual device case must be cleaned per specific manufacturer’s instructions (e.g. Brasseler powered hand pieces). • See Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions 97-5000-170-00 for guidance, which can be found at https://www.zimmerbiomet.com/medical-professionals.html. A. Initial Treatment at Point of Use 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 these 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 The majority of surgical instruments and trial prostheses instruments are constructed in such a way that they will not require disassembly. However, some of the more complex instruments are made of several components and these should be disassembled into their individual parts prior to cleaning. In most cases, the method of disassembly is self-evident. Loosen and/or disassemble instruments with removable parts. Screws or bolts on some instruments can be loosened for cleaning but are self-retaining to prevent loss. Care should be exercised to avoid losing small screws and components. If a part is lost, notify your Biomet representative when the instrument set is returned. Instruments with removable polymer sleeves must be disassembled for sterilization (e.g. acetabular reamer shaft with sleeve, side cutters, etc.). 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 (FDA approved, VAH listed, or CE mark) should be used. As a large variety of cleaning agents and disinfectants exists globally, Biomet does not recommend any specific brand. Agents used during the validation of these processing instructions are as follows: 1. Enzymatic and Neutral Detergents: Steris®, Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner and Prolystica® 2X Concentrate Neutral Detergent 2. Alkaline Detergent and Neutralilzer: neodisher® FA Alkaline Detergent and neodisher® Z Acid Neutralizer. 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. Dry powdered cleaning agents should be completely dissolved prior to use to avoid staining or corrosion of instruments and to ensure correct concentration. Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/or turbid). Note: It is important to select enzymatic solutions intended for breakdown of blood, body fluids and tissues. Some enzymatic solutions are specifically for breakdown of fecal matter or other organic contaminants and may not be suitable for use with instruments. C. Cleaning Methods The combination manual and automated cleaning instructions in Sections D or E shown and shown in Table 1 must be used to clean the instruments and the tray, case, and lid components. Instruments must be removed from the tray or case during the cleaning. Table 1 - Validated Cleaning Methods Method Combination of Manual and Automated Cleaning Using Enzymatic and Neutral Detergents
Combination of Manual and Automated Cleaning Using Alkaline Detergent and Neutralizer
Description Section Enzymatic soak and scrub, followed by enzymatic D sonication, followed by automated washer/ disinfector cycle with enzymatic and neutral detergents. Alkaline soak with sonication followed by E automated washer/disinfector cycle with alkaline detergent and neutralizer.
D. Combination Manual/Automated Cleaning Instructions Using Enzymatic and Neutral Detergents 1. Rinse soiled instruments, trays, cases, and lids under running cold tap water for a minimum of 1 minute. Remove gross soil and debris using a soft bristled, nylon brush.
2. Completely submerge the instruments, trays, cases, and lids in an enzyme solution and allow to soak for 10 minutes. Instruments must be removed from the trays or cases during the cleaning. Use a soft nylon bristled brush to gently scrub the device for a minimum of one minute and 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). Note: Use of a syringe or water jet will improve flushing of difficult to reach areas and closely mated surfaces. 3. Remove instruments, trays, cases, and lids from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 4. Completely submerge the instruments, trays, cases, and lids in an enzyme solution and sonicate for 10 minutes at 40±5 kHz. Instruments must be removed from the trays or cases during the cleaning. 5. Remove instruments, trays, cases, and lids from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 6. Place instruments, trays, cases, and lids in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle. Instruments must be removed from the trays or cases during the cleaning. The minimum parameters in Table 2 are essential for thorough cleaning and disinfection. Note: The washer/disinfector manufacturer’s instructions should be strictly adhered to. Use only cleaning agents recommended for the specific type of automated washer/disinfector. A washer/ disinfector with approved efficacy (e.g. CE mark, FDA clearance, and validation according to ISO 15883) should be used. Table 2 - 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 (X2) 5 2 minutes 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/176-200 °F) 8 10 second purified water rinse with optional lubricant (64-66 °C/146-150 °F) 9 7 to 30 minute hot air dry (116 °C/240 °F) 7. Proceed to Inspection, Maintenance, Testing, and Lubrication. E. Combination Manual/Automated Cleaning Instructions Using Alkaline Detergent and Neutralizer 1. Rinse soiled instruments, trays, cases, and lids under running cold tap water for a minimum of 1 minute. Remove gross soil and debris using a soft bristled, nylon brush. 2. Completely submerge the instruments, trays, cases, and lids in an alkaline (pH ≤12) solution and allow to sonicate for 10 minutes at 40±5 kHz. Instruments must be removed from the trays or cases during the cleaning. 3. Remove instruments, trays, cases, and lids from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 4. Place instruments, trays, cases, and lids in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle. Instruments must be removed from the trays or cases during the cleaning. The minimum parameters in Table 3 are essential for thorough cleaning and disinfection. Note: The washer/disinfector manufacturer’s instructions should be strictly adhered to. Use only cleaning agents recommended for the specific type of automated washer/disinfector. A washer/disinfector with approved efficacy (e.g. CE mark, FDA clearance, and validation according to ISO 15883) should be used. Table 3 - Typical European Automated Washer/Disinfector Cycle for Surgical Instruments Step Description 1 5 min pre-rinse with cold tap water 2 10 min alkaline cleaning agent wash at 55 °C 3 2 min rinse with neutralizer 4 1 min rinse with cold tap water 5 Disinfection at 93 °C with hot purified water until A0 3000 is reached (approx. 10 min) 6 40 min hot air drying at 110 °C 5. Proceed to Inspection, Maintenance, Testing, and Lubrication. INSPECTION AND MAINTENANCE 1. Carefully inspect each device to ensure that all visible contamination has been removed. If contamination is noted, repeat the cleaning/disinfection process. 2. Visually inspect for completeness, damage and/or excessive wear, including markings and other labeling. Note: If damage or wear is noted that may compromise the function of the instrument, contact your Biomet Representative for a replacement. 3. Check the action of moving parts (e.g. hinges, box-locks, connectors, sliding parts, etc.) to ensure smooth operation throughout the intended range of motion. 4. If necessary, hinged, rotating, or articulating instruments can be lubricated with an instrument product (e.g. Instrument Milk or equivalent lubricant) specifically designed for compatibility with steam sterilization. Spray a good amount of lubricant on the instrument, especially in hard to reach spaces, properly rub in the lubricant for a few seconds, and afterwards wipe off any remaining lubricant. Note: These lubrication instructions are not applicable to air-powered or electrical instruments. These devices have different requirements and should be lubricated according to the manufacturer’s instructions. Note: Lubricants not specifically designed for compatibility with steam sterilization should not be used because they may coat microorganisms, prevent direct contact of the surface with steam, or be difficult to remove. 5. Check instruments with long slender features (particularly rotating instruments) for distortion. 6. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components. PACKAGING A. Packaging Individual Instruments • 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 4. 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 and compliant with ISO 11607-1. • Standard medical grade, steam sterilization wrap may be used to package individual instruments. The package should be prepared using the AAMI double wrap or equivalent method. Note: If sterilization wraps are used, they must be free of detergent residues. Reusable wraps are not recommended.
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Table 4 - Recommended Steam Sterilization Parameters
ENGLISH 01-50-1539 EN Rev. C
Instructions for the Care, Cleaning, Maintenance, Handling, and Sterilization of Biomet Surgical Instruments and Instrument Cases
Cycle Type
Temperature2
Prevacuum/Pulsating Vacuum3 UK Prevacuum/Pulsating Vacuum3 Prevacuum/Pulsating Vacuum4, 11,12
132 °C / 270 °F 134 °C / 273 °F 134 °C / 273 °F
Exposure Time1,5 Wrapped6,7 and Unwrapped8 4 minutes 3 minutes 18 minutes
Minimum Dry Time9
Minimum Cool Time10
30 minutes
30 minutes
1
Validated exposure time required to achieve a 10-6 sterility assurance level (SAL). Validated exposure required to achieve a 10-6 sterility assurance level (SAL). 3 Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in this table. 4 Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination. 5 AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable. 6 Medical grade steam sterilization compatible wrap that is FDA cleared and compliant to ISO 11607-1. 7 Approved rigid sterilization container per these instructions may be used. 8 Flash (immediate-use) steam sterilization by exposure at 132-134°C / 270-273°F for the exposure times listed should only be used as an emergency procedure. Instruments must be cleaned and disassembled. 9 Drying times vary according to load size and should be increased for larger loads 10 Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79. 11 This cycle is not for use in the United States. 12 This cycle is not to be used for the inactivation of prions. 2
1AMEN015015392 B. Packaging Instrument Sets in Rigid Trays and Cases with Lids • Safety Precaution: The total weight of a wrapped instrument tray or case should not exceed 11.4kg/25lbs. Instrument cases may be placed in an approved sterilization container (e.g. Aesculap) with gasketed lids at the user’s discretion. The total weight of the instrument set, case, and sterilization container, must not exceed 11.4kg/25lbs (other local limits below 25 lbs. may apply). • Trays and cases with lids may be wrapped in standard medical grade, steam sterilization wrap using the AAMI double wrap method or equivalent. • The sterilization wrap used should be FDA cleared. • Trays and cases with lids may also be placed in an approved sterilization container with gasketed lid for sterilization. • The following list contains the approved rigid sterilization containers for use using these steam sterilization instructions: 0 Aesculap® SterilContainer™ 0 Case Medical SteriTite® • Follow the sterilization container manufacturer’s instructions for inserting and replacing sterilization filters in sterilization containers. C. Instrument Trays and Cases with Defined, Preconfigured Layouts • Areas designated for specific devices shall contain only devices specifically intended for these areas. • Optional Biomet instruments should not be added to a preconfigured instrument tray or case unless a dedicated universal space or compartment has been included in the design and the guidelines described below for trays and cases without defined layouts or universal spaces can be applied. D. Instrument Trays with Reconfigurable Layouts • Brackets designated for specific devices shall contain only devices specifically intended for them. • Brackets designed to force disassembly of a complex device must not be altered to allow the assembled device to be inserted into the tray or case. • To ensure devices are fully seated in their corresponding brackets, and to prevent damage to tray contents, individual brackets should not overlap one another when inserted into the tray floor. • Note: Some individual brackets may be designated for assembly onto other “host” brackets. In these instances, the mating relationship between the brackets will be graphically depicted on the face of the “host” bracket. • Bracket fasteners should be fully engaged with the tray floor to prevent unintended migration, damage, and/or loss of tray contents. • Wave springs positioned over the shaft of the bracket fasteners are intended to stabilize brackets by minimizing freeplay between them and the tray floor. To ensure intended function, periodically inspect brackets for damaged and/or missing springs which can be replaced by contacting your Biomet representative. • Identification tags and associated labels on trays should correspond to tray contents to ensure correct trays are available for use in surgery. • Any manual tools provided by Biomet to aid in the removal of individual brackets must not remain in the instrument trays during reprocessing and are not intended for use in surgery. Universal instrument trays and cases without defined, preconfigured layouts or containing undefined universal spaces or compartments should only be used under the following conditions: • 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. Silicone mats may be used to keep devices in place. STERILIZATION • Moist heat/steam sterilization is the preferred and recommended method for Biomet reusable devices. • 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. • Flash (immediate-use) steam sterilization by exposure at 132-134°C/ 270-273°F should only be used as an emergency procedure. Instruments must be cleaned and disassembled. • 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. Instrument cases should not be stacked during steam sterilization. • 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. • 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. See Table 4 for recommended minimum steam sterilization parameters 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. Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly.
STERILE INSTRUMENTS indicates Sterile devices are identified as such with the sterile symbol on the package label. The symbol indicates ethylene oxide sterilization, indicates steam or dry heat, and gamma sterilization, indicates sterilization using aseptic processing techniques. or on the package label. Devices which are provided non-sterile may be identified with the symbol Reusable medical devices sold sterile may be reprocessed using these instructions. Single use devices sold sterile may be reprocessed if not used unless labeling indicates the instrument is not to be reprocessed as indicated by the Do Not Resterilize symbol on the package label . Devices which are provided sterile and cannot be resterilized if the packaging or sterile barrier is damaged are indicated as symbol on the package label. such with the Similarly, in countries where local regulatory requirements permit the re-sterilization of “opened-but-unused” products only, the recommended steam sterilization parameters in Table 4 have been validated as providing a sterility assurance level (SAL) 10-6. Such devices may be reprocessed unless labeling indicates the instrument is not to be reprocessed as indicated by the Do Not Resterilize symbol . “Opened-but-unused” is the term used to refer to a sterile, single use or reusable medical device whose packaging has been opened or damaged but the device was not used and did not come in contact with blood, tissue or bodily fluids. Resterilization should be considered only where surgery is in progress and another suitable device is not available. The product must be cleaned and steam sterilized prior to use according to these instructions. In Canada, DO NOT RE-STERILIZE and DO NOT USE if the package is damaged or broken and sterility may be compromised. Always consult the device labeling and instructions for use for specific recommendations or restrictions on processing within a health care setting. DISPOSAL INFORMATION After use the instrument is a potential biohazard, since it may be contaminated with blood or other body fluids, bone, or tissue. Handle and dispose of product in accordance with accepted medical practice and with applicable local, state, and national laws and regulations. STORAGE AND SHELF LIFE • 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. • Care must be exercised in handling of wrapped cases or individual instruments to prevent damage to the sterile barrier. • The health care facility should establish a shelf life for sterilized instrumentation based upon the type of sterile wrap or rigid container used and the recommendations of the sterile wrap or rigid container manufacturer. • Sterile instrument packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. Note: Maintenance of sterile package integrity is generally event related. If a sterile wrap is torn, perforated, shows any evidence of tampering or has been exposed to moisture, the instrument set must be cleaned, repackaged and sterilized. Note: If there is any evidence that the lid seal or filters on a sterilization container have been opened or compromised, the sterile filters must be replaced and the instrument set resterilized. TRANSPORTATION • The instruments are supplied in their designated instrument trays. • The trays ensure that every instrument is kept in a way that they do not receive any damage and that their functionality is preserved during transportation. DISCLOSURE OF RESIDUAL RISKS Review the IFU of the associated implants for a list of residual risks associated with the use of that system. CAUTION: Federal Law restricts this device to sale by or on the order of a physician. Comments regarding Biomet devices or instruments can be directed to Attn: Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN 46581 USA, FAX: 574-372-3968. All trademarks herein are the property of Zimmer Biomet or its affiliates unless otherwise indicated. Steris® and Prolystica® are registered trademarks of Steris Corporation. Neodisher® is a registered trademark of Chemische Fabrik Dr. Weigert GmbH. Aesculap® and SterilContainer™ are trademarks of Aesculap AG. SteriTite® is a trademark of Case Medical, Inc. OR CE Mark on the package insert (IFU) is not valid unless there is a CE Mark on the product (description) label. European Community Authorized Representative:
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