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REUSABLE STERILIZATION CONTAINER SYSTEM. Validated container system for the DePuy Synthes Companies (Trauma, CMF, and Spine) instrument and implant sets.
USER'S MANUAL
TABLE OF CONTENTS
INTRODUCTION
Product Overview
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INSTRUCTIONS
Container Disassembly
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Container Filter Components and Assembly
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Container and Tray Assembly
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Container Cleaning
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Container Sterilization
15
Container Aseptic Presentation
18
Precautions
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Preventative Maintenance Checklist
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Warranty
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Return / Repair Policy
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Indications
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Product Part Numbers
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ADDITIONAL INFORMATION
Reusable Sterilization Container System
User's Manual
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PRODUCT OVERVIEW
The DePuy Synthes Reusable Sterilization Container System is an assortment of reusable containers that allows for the sterilization of the enclosed medical devices and maintain the sterility of the devices until used, for a maximum of 180 days. It is a container system validated to provide effective sterilization for DePuy Synthes Companies (Trauma, CMF, and Spine) instruments and implants. The container system is comprised of an anodized aluminum rivet-less case assembly (perforated lid with either perforated or solid base) with silicone gasket assembled using a stainless steel dual action latching mechanism. The perforated lids and bases have perforated retention plates that are intended to secure SMS Polypropylene filters in place over the sterilant access holes to allow air evacuation and steam sterilant penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport.
The DePuy Synthes Reusable Sterilization Container System also includes single-use filters, tamper-evident arrows with process indicators, and data cards. The system makes use of a stainless steel lifting platform to hold graphic cases containing orthopaedic instruments and implants within the container for sterile processing.
Retention Plate Filter Optional Protective Plate Testing of assembled, loaded containers up to a weight of 25 lb. (11 kg) has demonstrated that the contents can be effectively sterilized when the validated sterilization parameters are followed.* *Hospitals should refer to AAMI/AORN guidelines on weights and weight limit. Please refer to the Indications section for specific information regarding the types of devices and materials that are compatible with the sterilization container system.
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Reusable Sterilization Container System
User's Manual
Lid
CONTAINER DISASSEMBLY All container components should undergo a complete decontamination process after each use. In preparation for thorough cleaning, the container should be fully disassembled and decontaminated either mechanically or manually. See Container Cleaning section for complete cleaning instructions.
1. Open the lid Supporting the upper latch with thumb, place fingers under base latch on both ends of the container. Gently pull upward and outward on base latch plates. Simultaneously open both latches. This disengages the lid from the base. With the latch in the upright position, lift lid from the base.
2. Remove lifting platform from the container (if applicable) Ensure lifting platform handles are angled toward the center during removal to prevent binding of lifting platform handle with container base.
Reusable Sterilization Container System
User's Manual
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Container Disassembly
3. Remove Retention Plates from container lid and base (if applicable) Apply downward pressure on the retention plate near the lever and simultaneously rotate the cam lever away from the indentation protruding from the side of the lid. Discard the used filter - do not reuse. Remove the optional protective plate from the lid, if applicable.
4. Remove remaining single use accessories Inspect for tamper-evident arrow fragments that might be remaining under the handles in the arrow space on both sides of the container base. Discard fragments. Remove data card from container. Note: The data card may be retained as a record.
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Reusable Sterilization Container System
User's Manual
CONTAINER FILTER COMPONENTS AND ASSEMBLY
All DePuy Synthes Sterilization Containers use the same filter (62.010.002) and are validated for pre-vacuum steam sterilization only. The optional protective plate is shipped with the lid of every new container. The protective plate is for use with the pre-vacuum steam sterilization modality. Validated lethality and shelf life are achieved independent of optional protective plate use (i.e., use of this plate does not have an impact on shelf life or lethality). While the offset perforations of the lid and retention plate provide additional protection to the filter material, the use of the optional protective plate helps prevent puncture of the filter material from external objects.
1. If the optional protective plate is to be used, place the optional protective plate directly over the perforations (sterilant access holes). Note: The optional protective plates should be properly aligned with the rectangular shaped sterilant areas of the lid. Precaution: The optional protective plate has not been validated for use in the container base.
Reusable Sterilization Container System
User's Manual
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Container Filter Components and Assembly
2. Place a new filter on top of the optional protective plate and over the entire filter ridge surrounding each set of sterilant access holes (set of perforated holes) in the container lid or base. Alternate step if optional protective plate is not used: Place a new filter directly over the perforations (sterilant access holes) and over the entire filter ridge surrounding each sterilant access hole area in the container lid or base. Note: The filter should overlap the filter ridge on all four sides and will be secured between the filter retention plate and the lid or base when assembled. Precautions: •
Make sure filter does not overlap itself or become wrinkled or creased and is free of damage.
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Filters are for single-use only and must be discarded after each process.
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Do not use more than one filter per sterilant access hole area.
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Each set of sterilant access holes requires one filter.
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The filter must completely cover each plate area.
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Filters other than part number 62.010.002 have not been validated for use with the DePuy Synthes Reusable Sterilization Container System.
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Reusable Sterilization Container System
User's Manual
Container Filter Components and Assembly
3. Place the retention plate on top of the filter. Use the two alignment tabs on the filter retention plate to properly position it under the indentations. Make sure the retention plate is firmly seated under the indentation in the container lid or base.
Note: The filter retention plates are stamped “BOTTOM” or “TOP” as a guide for appropriate placement.
Reusable Sterilization Container System
User's Manual
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Container Filter Components and Assembly
4. Apply downward pressure to the plate near the lever and rotate the retention plate lever toward the indentation protruding from the side of the container. Note: Make sure the lever is rotated completely to the side of the container and the retention plate is locked firmly in place. Precaution: The filter must be placed between the optional protective plate (if used) and the retention plate.
Lid with assembled filter components.
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Reusable Sterilization Container System
User's Manual
CONTAINER AND TRAY ASSEMBLY
1. Confirm that the lid (and base, if perforated) has the appropriate filters and retention plates in place.
2. If needed, select the appropriately sized lifting platform and place instruments/implants set onto the lifting platform. Note: The use of lifting platform is required when using a perforated base container to hold the contents and avoid damaging the filter areas. It is not required for solid base containers.
3. Place instrument and/or implant set into the container. Notes •
Instrument trays from no more than one (1) loaded graphic case can be placed in the container.
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The container should never be overloaded with medical devices. Ensure devices are properly placed inside the container so nothing interferes with closure of the lid.
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If the lifting platform is used, ensure the lifting platform handles are angled toward the center during placement of set into the container.
4. Place an internal processing indicator, or integrator, in the set according to hospital protocols and policies. If the data card is to be used, place it in the data card block prior to putting the lid on the container.
5. Properly seat the lid on container base.
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User's Manual
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Container and Tray Assembly
LOCK THE CONTAINER 1. Interlock lid latch component with base latch component on both sides.
2. Press down with smooth continuous pressure until an audible snap is heard, confirming the latch is secured.
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Reusable Sterilization Container System
User's Manual
Container and Tray Assembly
INSERT THE TAMPER-EVIDENT ARROWS 1. Move the carrying handle to an upright position.
2. Orient the arrow so that the chemical indicator dot is facing outward.
3. Insert one arrow (62.010.004) into the open channel found under the right data block that holds the data card.
4. Advance the arrow until both sets of tabs have completely passed through the channel and are visible. When fully inserted, the tail portion of the arrow should be flush with the channel.
5. Grasp the arrow end with the indicator dot and gently pull back on the arrow to ensure that it is correctly placed and secure.
6. Repeat steps 1 through 5 for the other end of the container.
Not Fully Inserted
When completed, the container should have two fully inserted and secured tamper-evident arrows in place.
Fully Inserted
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User's Manual
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CONTAINER CLEANING
After each use, the containers and the lifting platforms should be washed with a properly diluted, enzymatic / neutral pH detergent solution recommended for use on anodized aluminum. A neutral pH is defined as 7. The post-dilution pH level should not be below 7 or exceed 9. Precautions: •
se only properly diluted, enzymatic/neutral pH detergent solution recommended for U safe use on anodized aluminum. Use of highly acidic or highly alkaline detergents could permanently damage the protective finish of the container.
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Alcohol is not recommended for manual cleaning or wiping down. All cleaning agents should be thoroughly rinsed off prior to any sterilization process to remove all residual chemicals that could damage the protective anodized finish.
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Do not use abrasive cleaners, abrasive cleaning pads, or metal brushes on container surfaces. Use of these abrasive materials will permanently damage the protective anodized finish of the container.
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o not clean the anodized container or container components (base, lid, retention D plate, optional protective plate) in an ultrasonic washer.
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ePuy Synthes lifting platforms are used to hold medical devices being sterilized D inside the container and should be routinely inspected for proper cleanliness. Lifting platforms should be scrubbed with a soft brush to reach hard-to-clean areas (e.g., handles of lifting platforms).
PRE-CLEANING INSTRUCTIONS It is recommended that containers be reprocessed as soon as is reasonably practical following use. Containers should be transported via the institution’s established transport procedure. Initiate cleaning of device within 2 hours of use. Excess gross soil should be removed as soon as possible after use by rinsing or wiping the device. All containers must be processed in the completely open and disassembled (i.e., taken-apart) configuration. Disassembly should not require any mechanical tooling (i.e., screwdriver, pliers, etc.) unless otherwise indicated.
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Reusable Sterilization Container System
User's Manual
Container Cleaning
CLEANING – MANUAL METHOD 1. Disassemble the container. 2. Rinse soiled container components under running cold tap water for a minimum of two minutes. Use a soft-bristled brush to assist in the removal of gross soil and debris. 3. Soak container components in neutral pH enzymatic cleaner or detergent solution for a minimum of ten minutes. Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct exposure time, temperature, water quality, and concentration. 4. Rinse container components with cold water for a minimum of two minutes. Use a syringe, pipette, or water jets to flush lumens, channels, and other hard to reach areas. Actuate joints, handles, and other moveable device features, if applicable, in order to rinse thoroughly under running water. 5. Manually clean container components for a minimum of five minutes in a freshly prepared neutral pH enzymatic cleaner or detergent solution. Use a soft-bristled brush to remove soil and debris. Actuate joints, handles and other movable device features to expose all areas to the detergent solution, if applicable. Clean device under water to prevent aerosolization of contaminates. Note: Freshly-made solution is a newly-made, clean solution. 6. Rinse container components thoroughly with deionized (DI) or purified (PURW) water for a minimum of two minutes. Use a syringe, pipette or water jet to flush lumens and channels. Actuate joints, handles and other moveable device features in order to rinse thoroughly under running water, if applicable. 7. Visually inspect container components. Repeat the manual cleaning procedure (steps 2-6) until no visible soil remains. 8. Perform a final rinse on device using DI or PURW water. 9. Dry container components using a clean, soft, lint-free cloth or clean compressed air.
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User's Manual
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Container Cleaning
CLEANING – MECHANICAL METHOD: MECHANICAL WASHER 1. Disassemble the container prior to cleaning. 2. Rinse soiled container components under running cold tap water for a minimum of one minute. Remove gross soil using a bristled brush or soft lint-free cloth. 3. Manually clean container components for a minimum of two minutes in a freshly prepared neutral pH enzymatic or detergent solution. Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct dilution, temperature, water quality, and exposure time. Use a soft-bristled brush to remove soil and debris. Actuate joints, handles, and other moveable device features to expose all areas to detergent solution. Clean container components under water to prevent aerosolization of contaminants. Note: Freshly-made solution is a newly-made, clean solution. 4. Rinse container components using cold to lukewarm running tap water for a minimum of one minute. Use a syringe, pipette or water jet to flush lumens and channels. Actuate joints, handles, and other moveable device features in order to rinse thoroughly under running water. 5. Visually inspect device. 6. Mechanical Washer process (Pre-cleaning steps 2-5 should occur prior to this step.): Cycle
Minimum Time (minutes)
Minimum Temperature/Water
Type Detergent
Pre-Wash
2
Cold tap water
N/A
Wash I
2
Cold to Warm tap water
Neutral enzymatic pH between 7 and 9
Wash II
5
Warm tap water (>40°C)
Detergent with pH between 7 and 9
Rinse
2
Warm DI or PURW (>40°C)
N/A
Dry
40
90°C
N/A
7. Visually inspect device. Repeat steps 2 - 6 until no visible soil remains.
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Reusable Sterilization Container System
User's Manual
CONTAINER STERILIZATION
RECOMMENDED STERILIZATION CYCLE PARAMETERS The following recommendations may include sterilization temperature/exposure parameters and maximum loads different from those which your institution commonly uses. Since individual sterilizers may perform differently, it is important to conduct individual sterilizer testing of containerized instrument sets using biological and chemical indicators to verify exposure times and to determine adequate sterilizing parameters in your particular facility. These recommendations represent specific validated settings, but are not inclusive of all possible combinations of settings and variables that could produce acceptable results. The recommendations below were generated to cover a worst case DePuy Synthes Sterilization Container with typical load contents. The end user is ultimately responsible for establishing and following protocols to ensure properly sterilized and dried sets. Sterilizers vary in design and performance characteristics. It is strongly recommended that the user verify the cycle parameters for the specific sterilizer prior to use. It is important to verify the parameters in conjunction with the sterilizer, load contents and any other processing accessories that may be used. Adjusted cycle times or dry times may be required to properly sterilize and dry desired loads.
SPECIFIC RECOMMENDATIONS FOR ACCESSORIES AND CONTAINERS Pre-vacuum Steam Sterilization Cycle for all Perforated and Solid Base Containers •
Exposure Temperature: 270°F (132°C)
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Preconditioning Pulses: 3
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Exposure Time: 4 minutes
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Minimum Dry Time Cycle with total weight of 25 lbs. (11 kg): 30 minutes*
*When applying dry times to DePuy Synthes Instrument & Implant Sets and their accessories, dry times outside the standard healthcare pre-vacuum parameters may be required. The dry time is frequently influenced by the presence of polymer based (plastic) materials; therefore, changes such as reduced weight and/or elimination of silicone mats can reduce necessary dry time. Dry times may be highly variable due to differences in environmental conditions, steam quality, device materials, total mass, sterilizer performance and varying cool down time. The user should employ verifiable methods (e.g. visual inspections) to confirm adequate drying.
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User's Manual
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Container Sterilization
PRECAUTIONS •
Do not obstruct the sterilant access holes. These holes allow the exchange of air and penetration of sterilant into and out of the container. Blockage of these holes can impede the exchange process. Under pre-vacuum steam, this blockage can cause the container to collapse.
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Stacking the containers during sterile processing is not permitted.
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Instrument trays from no more than one (1) loaded graphic case can be placed in the DePuy Synthes Sterilization Container.
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Stand-alone modules/racks or single devices must be placed, without stacking, on a lifting platform to ensure optimal ventilation.
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Do not use adhesive tape on the container. Removal of adhesive residue may result in cosmetic damage to the container.
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The use of basket liners may cause condensate to pool.
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The 62.010.002 filter to be used with DePuy Synthes Reusable Rigid Sterilization Containers is for single use only. One filter sheet, or thickness, should be used underneath each retention plate per process. Using more than one thickness of the recommended filter has not been validated for efficacy. Each sterilant access (perforated) area requires one filter.
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Filter materials other than the 62.010.002 filters have not been validated for use with the DePuy Synthes Sterilization Containers.
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When using a perforated base DePuy Synthes Sterilization Container, a lifting platform must be used to hold the contents and avoid damaging the filter areas.
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Sterilize container and contents using hospital protocol. Since sterilizers vary in design and performance characteristics, it is strongly recommended that the user verify the cycle parameters for the specific sterilizer and types of instruments being sterilized prior to use.
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DePuy Synthes Reusable Sterilization Container System is only approved for pre-vacuum steam sterilization.
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Only the recommended filters, tamper-evident arrows, data cards, lifting platforms and repair parts are validated for use with the DePuy Synthes Reusable Sterilization Container System. Do not use unauthorized single-use accessories or container components.
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The optional protective plate has not been validated for use in the DePuy Synthes Container Base.
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Reusable Sterilization Container System
User's Manual
Container Sterilization
WARNINGS Do not use filter materials in the presence of flammable anesthesia. A safety hazard may occur.
LOADING AND COOLING When fully assembled, the container is ready for sterile processing. DePuy Synthes Reusable Sterilization Container System is only indicated for pre-vacuum steam sterilization. •
Minimum Cool Time: 60 minutes (may vary according to the load contents).
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The containers should be positioned flat on the cart and not placed on their sides or upside down.
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Do not place containers above wrapped items.
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Always practice safe lifting and handling of heavy objects.
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Make sure sterilant access holes (perforations) on the containers are not obstructed.
Precautions: •
Do not remove containers from the carrier until cool to touch or place warm containers on cold tabletops. Proper cool down is necessary to prevent wet sets or condensation from forming.
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Eliminate drastic temperature differences by keeping the container away from cool ventilation ducts and cool drafts. Rapid cooling can cause condensation to form, resulting in wet sets.
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Do not place processed containers into the sterile storage area until they reach room temperature.
CART LOADING GUIDELINES Always place containers flat on shelves.
180-DAY EVENT-RELATED SHELF-LIFE STUDY DePuy Synthes Test Containers were sterilized using pre-vacuum steam sterilization. The fully loaded containers were transferred to wire storage shelves and held for 180 days. The containers were periodically rotated to simulate normal handling and to provide an equal challenge to all units. After 180 days, the units were assessed for sterility. The contents of all containers were sterile, indicating that sterility was maintained for the indicated eventrelated shelf life duration. Note: Do not stack more than four (4) containers high during storage. Reusable Sterilization Container System
User's Manual
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CONTAINER ASEPTIC PRESENTATION
The DePuy Synthes Reusable Sterilization Container System provides the operating room personnel with an exterior tamper-evident arrow to help visually communicate that the container has been subjected to a sterilization process and has not been tampered with (opened) prior to its intentional opening at the point of use. Chemical and/or biological indicators may be incorporated into the assembly process and provide critical information to the end user to establish whether the internal contents are safe to use. The indicator to be used is the decision of the hospital based on individual hospital protocol and current guidelines. Inspection should also be conducted at the point of use to ensure that the filter has been inserted properly, that the retention plates are secure, that there is no visible damage to the gasket found in the lid, and that contents are dry. If the filter is missing, the retention plate is not secure, the gasket is visibly damaged, the arrow is missing or broken, or the dot has not changed color the container should be considered contaminated and not used. Inspecting these external and internal devices is important prior to placing any contents into the sterile field. The container itself is not to be placed into a sterile field because the container exterior is not sterile. In general, the contents are removed by carefully lifting them up and away from the container base edge (lip) and placed into the sterile field.
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Reusable Sterilization Container System
User's Manual
Container Aseptic Presentation
STERILITY MAINTENANCE GUIDELINES The contents of a container should not be considered sterile if any of the following conditions are present: •
A filter is missing from any of the perforated areas.
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A retention plate is dislodged or not fully engaged.
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A filter does not cover the raised edges (filter ridge) surrounding the perforated areas on the lid or base.
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A filter is wet.
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A filter is damaged, torn, ripped, punctured, or creased (folded over onto itself).
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More than one filter per filter retention area is used for processing or the filter material has been folded forming more than one layer over the perforations.
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A filter has been reused.
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A tamper-evident arrow is missing or broken in either of the two data blocks.
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The indicator dot is missing from the tamper-evident arrow at the time of opening.
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The indicator dot does not indicate a noticeable color change.
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There is no internal chemical indicator found in the container when opened (if hospital protocol dictates that one should be present).
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The internal chemical indicator (if present, per hospital protocol) does not indicate the item has been processed when used according to the manufacturer’s recommendations for use.
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The gasket is either damaged or separated from its retaining groove.
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The base lip is damaged or dented causing a gap or break in the compression indentation in the gasket.
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There is residual water or condensation within the container at the point of use.
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User's Manual
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