Instructions for Processing Medical Devices – Reusable Instruments, Instrument Trays and Cases

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0902-60-001 Rev. A

en

*Refer to label for CE mark and identification number of the notified body responsible for conformity assessment (if applicable).

Instructions for Processing Medical Devices – Reusable Instruments, Instrument Trays and Cases INSTRUCTIONS FOR USE IMPORTANT INFORMATIONPlease read before use For access to the e-IFU and any additional languages visit www.e-IFU.com Introduction DePuy Synthes reusable instruments are critical medical devices. These devices must be cleaned, inspected and sterilized prior to use. These instructions are provided to assist health care personnel in the development of effective procedures for the processing of reusable devices. It is the responsibility of the facility to ensure that processing is performed using the equipment, materials and competent personnel at a designated processing area. These instructions are provided for heat-resistant, critical medical devices, unless otherwise noted on the product specific instructions for use (IFU). Product specific IFU’s are given priority over these instructions. This can include heat-sensitive devices and certain power (air- or electric-driven) tool designs that are provided with specific cleaning and sterilization instructions. Consult the product specific IFU for processing in these cases. DePuy Synthes Instruments do not have an indefinite functional life. All reusable instruments 2020-02-26 14:55:55 12:35:55 2020-02-26

are subjected to repeated stresses related to surgical use, routine cleaning, and sterilization processes. Instruments should be carefully inspected before each use to ensure that they are functional. Scratches, dents or other damage can result in instrument breakage or tissue injury. Warnings and Cautions These instructions are provided for the processing of heat-resistant, immersible, critical medical devices, unless otherwise noted on specific product inserts. Information given in product specific IFU are given priority over these instructions. This can include heat-sensitive devices and certain power (air- or electric-driven) tool designs that are provided with specific cleaning and sterilization instructions. Consult the product specific instructions for processing in these cases. The instructions provided are given as guidance for medical device processing and have been validated by the manufacturer. It is the responsibility of the healthcare facility to ensure that processing is performed using the required equipment, materials and personnel at a defined processing area. This will include the handling of devices during transportation, processing and storage prior to use.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Those using these instructions should be qualified personnel with documented training and competency in accordance with local procedures, guidelines, and standards. Surgically used instruments can be considered a biohazard and facilities should ensure that transport and handling procedures comply with local regulations and guidelines. Reusable, non-sterile instruments are required to be cleaned, inspected and sterilized prior to use. Care should be taken in the handling and cleaning of sharp devices. All devices must be thoroughly cleaned and inspected prior to sterilization. Long, narrow lumens, blind holes, moving and intricate parts require particular attention during cleaning and inspection. During cleaning, only use detergents that are labelled for use on medical devices and in accordance with the manufacturer’s instructions (eg temperature, contact time, and rinse time). Cleaning agents with a used dilution pH of within 7 – 9.5 are recommended. Highly alkaline conditions (pH>10) can limit the lifetime of components / devices, such as aluminum materials. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products). Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes. Instruments should be carefully inspected before each use to ensure that they are functional. Scratches, dents or other damage can result in instrument breakage or tissue injury. Instruments must be cleaned separately from instrument trays and cases. Instrument trays and cases are designed as an organizational tool in preparation for sterilization, storage and surgical use. Automated equipment, including washerdisinfectors and steam sterilizers must be installed, maintained and operated in accordance with manufacturer’s instructions. Do not exceed 140oC (284oF) during processing steps.

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For patients with, or suspected with, CreutzfeldtJakob disease (CJD), variant CJD or other transmissible spongiform encephalopathy (TSE) and related infections, it is recommended to treat the patient using single-use instruments. Safely dispose of all devices used in accordance with local procedures and guidelines. Limitations on Processing Repeated processing cycles in compliance with these instructions for use have minimum effects on device life and function. Instruments do not have an indefinite functional life. End of life of devices is determined by wear and damage due to surgical use and handling. Evidence of damage and wear on a device may include but is not limited to corrosion (i.e. rust, pitting), discoloration, excessive scratches, flaking, wear and cracks. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used. Step 1: Point of Use Care All single use devices and materials should be removed and discarded in accordance with local procedures and guidelines. The drying of gross soil (blood, tissue and/or debris) on devices following surgical use should be avoided. It is preferred that gross soil is removed from devices following use and in preparation for transportation to a processing area. Gross soil can be removed using sponges, cloths, or soft brushes. Water and/or cleaning detergents (labelled for use on medical devices) may be used. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products. Flush all lumens, blind holes, small clearances, and moving and intricate parts with water (or detergent solution) to prevent the drying of soil and/or debris. If gross-soil cannot be removed at the point of use, the devices should be transported to prevent drying (e.g., covered with a towel dampened with purified water) and cleaned as soon as possible at a designated processing area.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Surgical cement should be removed from devices during surgical use and prior to setting. When cement hardens, it will typically require physical methods to remove. Chemical solvents should not be used. Hardened cement may be removed with an approved stylus or removing tool, but these may damage devices. Step 2: Containment and Transportation Surgically used devices may be considered bio-hazardous and should be safely transported to a designated processing area in accordance with local policies. Step 3: Cleaning Preparation before Cleaning It is recommended that devices should be reprocessed as soon as is reasonably practical following surgical use. Instruments must be cleaned separately from instrument trays and cases. Care should be taken in the handling and cleaning of sharp devices. These are recommended to be cleaned separately to reduce risks of injury. Multi-part or complex instruments may require disassembly for cleaning. Refer to any technique guides, disassembly instructions, assembly instructions or other supplemental information for specific device disassembly and/or reassembly instructions. Any devices with moving parts (e.g. ratchets, box locks, hinges or actuated parts) need to be actuated during manual cleaning and rinsing to ensure access of the cleaning process. All devices with lumens need to be manually flushed to remove debris and brushed thoroughly using appropriately sized soft-bristled brushes and twisting action. Brush size should be approximately the same diameter of the lumen to be cleaned. Using a brush that is too big or too small for the diameter of the lumen/cannulation may not effectively clean the lumen. Refer to any technique guides or other supplemental information for specific device lumen diameters. After brushing, rinse with water by flushing and blowing clean compressed air through all lumens.

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NOTE: Two cleaning methods are provided, a Manual and an Automated Method, and at least one shall be performed. Cleaning: Manual 1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9.5) in accordance to the detergent manufacturer’s instructions. The temperature of the solution should be ≤ 40°C (104°F) for manual cleaning. NOTE: The cleaning solution may contain enzymes. Aluminum-safe alkaline cleaners can be used but can vary in material compatibility overtime based on their formulation. Material compatibility should be confirmed with the detergent manufacturer. 2. Immerse devices and parts in the detergent solution, and soak for a minimum of 5 minutes. 3. While immersed, use a soft non-metallic bristle brush (plastic bristles, like nylon) to thoroughly clean all traces of blood and debris from all device surfaces for a minimum of one minute. 4. Ensure all lumens are thoroughly brushed. Push the brush through the entire length of the lumen using a twisting motion to remove debris from both ends for a minimum of one minute. 5. During cleaning, actuate joints, handles and other movable device features to expose all areas to the detergent solution, if applicable. Ensure all lumens, blind holes, small clearances, and moving and intricate parts are flushed for a minimum of one minute. 6. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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7. Completely submerge the devices in an ultrasonic bath prepared with a neutral or mild alkaline pH detergent (pH 7-9.5), prepared in accordance with the manufacturer’s instructions. Use a large syringe (50ml or greater) flush all lumens, blind holes, small clearances, and moving and intricate parts with the detergent solution to minimize the formation of air pockets or bubbles. NOTE: Ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of ultrasonic cleaning. 8. Ultrasonically clean the device components for a minimum of 10 minutes in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included 40kHz at 25°C for 10 mins). 9. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 10. Remove the devices and repeat the rinsing using in ambient, < 40°C (104°F) critical water (high purity water generated by processes such as reverse osmosis, deionization or distillation) for at least 15 seconds. 11. Remove and dry device using a clean, soft, lint-free cloth or clean compressed air. Ensure that all lumens and articulated areas are dried using compressed air Cleaning: Automated 1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9.5) in accordance to the detergent manufacturer’s instructions. The temperature of the solution should be ≤40°C (104°F) for manual cleaning.

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NOTE: The cleaning solution may contain enzymes. Aluminum-safe alkaline cleaners can be used but can vary in material compatibility overtime based on their formulation. Material compatibility should be confirmed with the detergent manufacturer. 2. Immerse devices and parts in the detergent solution, and soak for a minimum of 5 minutes. 3. While immersed, use a soft non-metallic bristle brush (plastic bristles, like nylon) to thoroughly scrub all traces of blood and debris from all device surfaces for at least one minute. 4. Ensure all lumens are thoroughly brushed. Push the brush through the entire length of the lumen using a twisting motion to remove debris from both ends for at least one minute 5. During cleaning, actuate joints, handles and other movable device features to expose all areas to the detergent solution, if applicable. Ensure all lumens are flushed for at least one minute. 6. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 7. Completely submerge the devices in an ultrasonic bath prepared with a neutral or mild alkaline pH detergent (pH 7-9.5), prepared in accordance with the manufacturer’s instructions. Use a large syringe (50ml or greater) flush all lumens, blind holes, small clearances, and moving and intricate parts with the detergent solution to minimize the formation of air pockets or bubbles. NOTE: Ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of ultrasonic cleaning.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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8. Ultrasonically clean the device components for a minimum of 10 minutes in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included 40kHz at 25°C for 10 mins). 9. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 10. Load the device components in the washerdisinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens have maximum exposure to detergents and rinse water and can drain freely. 11. Automated washing shall be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and-2, or to an equivalent standard. Automated washing can be included as part of a validated washing, disinfection, and/ or drying cycle in accordance to manufacturer’s instructions. An example of a validated cycle used for cleaning validation included: Phase

Recirculation Time (mins) Pre-Wash 2

Enzyme wash

1

Wash

5

Rinse

2

Rinse

0.25

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Water Temp Cold Tap Water < 40°C (104°F) 66°C (151°F) > 40°C (104°F) Ambient

Detergent/ Water Type N/A

Neutral, Enzymatic Cleaner Neutral pH Detergent Tap water Critical water (RO, deionized or distilled water)

Step 4: Thermal Disinfection Thermal disinfection is recommended to render devices safe for handling prior to steam sterilization. Thermal disinfection should be conducted in a washer-disinfector compliant to ISO 15883-1 and-2, or to an equivalent standard. Thermal disinfection in the washer-disinfector shall be validated to provide an A0 of at least 600 (e.g., 90°C (194°F) for 1 min). Higher levels of A0 can be achieved by increasing the exposure time and temperature (e.g., A0 of 3000 at > 90°C (194°F) for 5 min, in accordance with local requirements). Load the device components in the washer-disinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens can drain freely. Lumened devices should be placed in a vertical position. If this is not possible due to space limitations within the washer-disinfector, use an irrigating rack /load carrier with connections designed to ensure an adequate flow of process fluids to the lumen or cannulation of the device if provided. The following automated cycles are examples of validated cycles: Phase

Recirculation Water Water Time (mins) Temp Type Thermal 1 > 90°C Critical Disinfection (194°F) water (RO, deionized or distilled water) Thermal 5 > 90°C Critical Disinfection (194°F) water (RO, deionized or distilled water) Step 5: Drying It is recommended that drying is conducted in a washer-disinfector compliant to ISO 15883-1 and-2, or to an equivalent standard. Drying efficiency in washer-disinfectors can range considerably based on the automated system design and load configuration. The following automated cycle is an example of a validated cycle:

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Phase Dry

Recirculation Time (mins) 7

Air Temp

Air Type

115°C (239°F)

Medical grade

Following automated drying, inspect the device for residual moisture. Any residual moisture identified should be dried manually (as described below). For manual drying: • Ensure each device is dried and inspected thoroughly. • For external surfaces, use a clean, soft, lint-free cloth to avoid damage to the surface. • Open and close, or actuate any applicable devices with moving parts during drying. Pay special attention to any device threads, ratchets and hinges or areas where fluid can accumulate. Clean, compressed air (e.g., medical grade) may be used to facilitate surface drying. • Dry all lumen/cannulated parts using clean compressed air (e.g., medical grade). Step 6: Maintenance and Inspection Instruments should be visually inspected under ambient lighting, to verify that the devices do not have visible soil, damage or moisture. Inspect devices for: 6 (a) Lack of moisture. Carefully inspect device lumens and moving parts. If moisture is detected, manually drying should be performed. 6 (b) Cleanliness. If any residual soil is discovered during inspection, repeat the cleaning steps on those devices until all visible soil is removed from the device. 6 (c) Damage, including but not limited to, corrosion (rust, pitting), discoloration, excessive scratches, flaking, cracks and wear 6 (d) Proper function, including but not limited to, sharpness of cutting tools, bending or distortion of devices, movement of hinges/joints/box locks and moveable features such as handles, ratcheting and couplings and missing or removed part numbers

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6 (e) Improperly functioning devices, devices with unrecognizable markings, missing or removed part numbers, damaged and worn devices should be discarded. Disassembled devices should be reassembled prior to sterilization when specified. Lubricate any moving parts with a water-soluble surgical instrument lubricant. The lubricant should be approved for use on medical devices and provided with data to ensure biocompatibility and compatibility with steam sterilization. Step 7: Packaging Place cleaned, dry devices into the specified locations within the cases provided, if applicable. Only legally marketed, and locally approved sterilization barriers (e.g. wraps, pouches or containers) should be used for packaging terminally sterilized devices, in compliance to the manufacturer’s instructions. Step 8. Sterilization Steam (moist heat) sterilization shall be performed in a locally approved, pre-vacuum (forced air removal) cycle. The steam sterilizer should be validated to the requirements of any local standards and guidance such as EN 285 or AAMI/ANSI ST8. The steam sterilizer should be installed and maintained in compliance to manufacturer’s instructions and local requirements. Ensure that the steam sterilizer cycle is chosen that is designed to remove air from porous or lumened device loads in accordance to manufacturer’s instructions and does not exceed the criteria for sterilizer load. The following steam sterilization cycles are examples of validated cycles: Conditioning Minimum Minimum Phase Sterilization Sterilization Exposure Exposure Time Temperature (minutes) Prevacuum 4 132°C (270°F) Prevacuum

3

Dry Time

30 minutes 134°C (274°F) 30 minutes

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Extended steam exposure cycle can be used to meet local requirements such as 134°C (274°F) for 18 minutes. The efficiency of steam sterilizer drying can range considerable depending on the sterilizer design, loading, packaging and steam supply during the sterilization process. The user should employ verifiable methods (e.g. visual inspections) to confirm adequate drying. Extended drying within the sterilizer or in an external drying cabinet in accordance with manufacturer’s instructions may be necessary. Do not exceed 140°C (284°F) during drying. Immediate-Use steam sterilization is only intended for individual instruments and should only be performed when approved by local policies. DePuy Synthes does not support immediate-use steam sterilization of instrument sets or cases using this method. The following steam sterilization cycle is an xample of a validated cycle for individual instruments only: • Unwrapped instrument • A minimum 3 (three) pulse prevacuum cycle • 132°C (270°F) for 4 minutes Step 9: Storage Sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity.

The chemical quality of the water used during processing can impact device safety. Facilities should use the recommended water quality requirements for device processing in accordance with local guidance (such as AAMI TIR 34, Water for the reprocessing of medical devices) and these instructions for use. These instructions for use have been validated in accordance with ISO 17664. It remains the responsibility of the facility to ensure that the processing is performed using equipment, materials and personnel at a designated area, and achieves the desired requirements. This includes validation and routine monitoring of the process. Likewise, any deviation by the processor from these recommendations should be evaluated for effectiveness and any potential adverse consequences. All personnel using these instructions should be qualified with documented expertise, competency and training. Users should be trained on healthcare facility policies and procedures along with current applicable guidelines and standards. Where further information is desired, please contact your local DePuy sales representative. For instruments produced by another legal manufacturer, reference the manufacturer’s instructions for use

Refer to sterilization wrap or rigid container manufacturers IFU for limits on sterile product storage time and storage requirements for temperature and humidity. Additional Information Cleaning agent information: Examples of detergents that have been used during cleaning validations include ProlysticaTM 2X Concentrate Enzymatic Cleaner, ProlysticaTM 2X Neutral Detergent, EnzolTM, EndozimeTM, Neodisher MedizymTM, Terg-A-ZymeTM, and NpH-KlenzTM. Further information regarding the use of specific cleaning agents, ultrasonic washers, washerdisinfector, packaging materials or sterilizers during validation studies are available on request. 2020-02-26 14:55:55 12:35:55 2020-02-26

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Ireland Tel: +353 214914278 Fax: +353 214914199 Issued 2019-12 © DePuy Synthes 2019. All rights reserved. 2020-02-26 14:55:55 12:35:55 2020-02-26

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.