Non-Sterile Synthes Implants Reprocessing Instructions

Equipment: Ultrasonic cleaner, various sized soft-bristled brushes, lint-free cloths, syringes, pipettes and/or water jet, neutral enzymatic cleaner or neutral detergent with pH between 7 and 9.

ProcessingMechanical MethodUltrasonic

Pre-clean method (Pre-clean method must be performed prior to ultrasonic mechanical method listed below.) 1. Rinse device under running cold tap water for a minimum of two minutes. Use a soft-bristled brush to clean the device. 2. Soak device in a 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. 3. Rinse device with cold water for a minimum of two minutes. Use a syringe, pipette, or water jet to flush lumens, channels, and other hard to reach areas. 4. Manually clean device for a minimum of five minutes in a freshly prepared neutral pH enzymatic cleaner or detergent solution using a soft-bristled brush. Clean device under water to prevent aerosolization of contaminants. Note: freshly prepared solution is a newly made, clean solution. 5. Rinse device thoroughly using cold or warm tap water for a minimum of two minutes. Use a syringe, pipette, or water jet to flush lumens and channels. 6. Visually inspect device. Ultrasonic process: (Pre-cleaning steps 1-7 should occur prior to this step.) 7.

Prepare a fresh detergent solution using a neutral pH enzymatic cleaner or detergent. Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct exposure time, temperature, water quality, and concentration. Note: freshly prepared solution is a newly made, clean solution. 8. Clean Synthes device ultrasonically for a minimum of 15 minutes. 9. Rinse device 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. 10. Visually inspect device. 11. Perform a final rinse on device using DI or PURW water for a minimum of 15 seconds. 12. Dry device using a clean soft, lint-free cloth or clean compressed air. Equipment: Ultrasonic cleaner, washer/disinfector, various sized soft-bristled brushes, lint-free cloths, syringes, pipettes, and/or water jet, neutral enzymatic cleaner or neutral detergent with a pH between 7 and 9.

ProcessingMechanical MethodMechanical Washer

Pre-clean method (Pre-clean method must be performed prior to mechanical washer method listed below.) 1. Rinse device under running cold tap water for a minimum of one minute. 2. Manually clean device for a minimum of two minutes in a freshly prepared neutral pH enzymatic or detergent solution using a soft-bristled brush. Follow the enzymatic cleaner or detergent manufacturer’s instructions for the correct dilution, temperature, water quality, and exposure time. Clean device under water to prevent aerosolization of contaminants. Note: freshly prepared solution is a newly made, clean solution. 3. Rinse device 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. 4. Prepare a fresh detergent solution using a neutral pH enzymatic cleaner or detergent. Follow the enzymatic cleaner or detergent manufacturer’s instructions for the correct dilution, temperature, water quality, and exposure time. Note: freshly prepared solution is a newly made, clean solution. 5. Clean Synthes devices ultrasonically for a minimum of 15 minutes. 6. Rinse device using DI or PURW water for a minimum of two minutes. Use a syringe, pipette, or water jet to flush lumens and channels. DI or PURW water must be used for final rinse. 7. Visually inspect device. Mechanical Washer process: (Pre-cleaning steps 1-8 should occur prior to this step.) 8.

Process device using the following cycle parameters:

Pre-wash

Minimum Time (minutes) 2

Minimum Temperature/Water Cold tap water

Wash I

2

Cold to warm tap water

Wash II Rinse Dry

5 2 40

Warm tap water (>40°C) Warm DI or PURW (>40°C) 90°C

Cycle

Form (Non-PPE) | 103509581 | Rev. 2 | Ref: W-D-S072

Type of Detergent N/A Neutral enzymatic pH between 7 and 9 Detergent with pH between 7 and 9 N/A N/A

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Thermal disinfection Inspection

Packaging

For automated cleaning, thermal disinfect at 93°C for minimum of 2 minutes and 30 seconds. • • •

Synthes implants should be inspected after processing, prior to sterilization. Any implant with corrosion, discoloration, scratches, flaws, residue or debris should be discarded. Only legally marketed, FDA-cleared sterilization barriers (e.g. wraps, pouches, or containers) should be used by the end-user for packaging terminally sterilized devices.

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Rigid Sterilization Container Use Instructions and Considerations In order to ensure proper sterilization of Synthes’ devices when using a rigid sterilization container, the following must be taken into consideration: o Only FDA-cleared rigid sterilization containers may be used with Synthes’ devices and loaded graphic cases (a graphic case with all or part of its assigned contents). o The rigid sterilization container manufacturer’s instructions for use are to be followed. If questions arise regarding the use of the rigid sterilization container, Synthes recommends contacting the manufacturer of that specific container for guidance. o The options in using rigid sterilization containers with Synthes’ devices and loaded graphic cases are as follows:  No more than one (1) fully loaded graphic case can be placed into a rigid sterilization container.  Instrument trays from no more than one (1) loaded graphic case can be placed in the rigid sterilization container.  Stand-alone modules/racks or single devices must be placed, without stacking, in a container basket to ensure optimal ventilation. o Rigid sterilization container must have a maximum volume to vent ratio of no greater than 127 in3/in2. For any questions related to the volume to vent ratio, please contact the container manufacturer. o Only rigid sterilization containers approved for pre-vacuum steam sterilization can be used with Synthes’ devices and loaded graphic cases following the sterilization parameters provided by Synthes. o End-users should follow ANSI/AAMI ST79 for additional information concerning the use of rigid sterilization containers.

The following are the recommendations for the sterilization of Synthes’ implants:

Sterilization

Cycle Type

Sterilization Exposure Time (minutes)

Sterilization Exposure Temperature

Minimum Dry Time*

Prevacuum

4

132°C (270°F)

20 minutes

*When applying dry times to Synthes cases and their accessories, dry times outside the standard healthcare prevacuum parameters may be required. This is especially important for polymer-based (plastic) cases/trays used in conjunction with heavy duty nonwoven sterilization wraps. The current recommended dry times for Synthes cases can range from a standard 20 minutes to an extended time of 60 minutes. The dry time is most often influenced by the presence of polymer based (plastic) materials; therefore, changes such as elimination of silicone mats and/or change in sterile barrier system (e.g. heavy grade to light grade wrap or the use of rigid sterilization containers) can reduce the necessary dry time. Dry times may be highly variable due to differences in packaging materials (e.g. nonwoven wraps), environmental conditions, steam quality, implant materials, total mass, sterilizer performance, and varying cool down time. The user should employ verifiable methods (e.g. visual inspections) to confirm adequate drying. • The autoclave manufacturer’s operating instructions and recommended guidelines for maximum sterilization load should be followed. The autoclave must be properly installed, maintained, and calibrated. Only legally marketed, FDA-cleared sterilization barriers (e.g. wraps, pouches, or containers) should be used by the end-user for packaging terminally sterilized devices. • For product sold sterile, refer to device specific insert for limitations regarding resterilization.

Form (Non-PPE) | 103509581 | Rev. 2 | Ref: W-D-S072

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Additional Information

Manufacturer Contact

Sterile product that has exceeded the labeled expiration date and has intact and undamaged original packaging may be sterilized using the above sterilization parameters unless product is coated, i.e HA, plasma, etc. or resterilization is not permitted. Refer to device specific insert for limitations regarding resterilization. • Cleaning Agent Information: Synthes used the following cleaning agents during validation of these reprocessing recommendations. These cleaning agents are not listed in preference to other available cleaning agents which may perform satisfactorily- neutral pH enzymatic detergents (e.g. Prolystica 2X Concentrate Enzymatic Cleaner, Enzol, Endozime, and Neodisher Medizym) and neutral pH detergents (e.g. Prolystica 2X Neutral Detergent). • The cleaning and sterilization information is provided in accordance with ISO 17664, AAMI TIR 12, ANSI/AAMI/ISO 17665-1, ANSI/AAMI ST79, and AAMI ST77. • The recommendations provided above have been validated by the medical device manufacturer as being capable of preparing a non-sterile Synthes medical implant. It remains the responsibility of the processor to ensure that the processing is actually performed, using equipment, materials, and personnel in the reprocessing facility, and achieves the desired result. This requires verification and routine monitoring of the process. Likewise, any deviation by the processor from the recommendations provided should be properly evaluated for effectiveness and potential adverse consequences. • All users should be qualified personnel with documented expertise, competency, and training. Users should be trained on hospital policies and procedures along with current applicable guidelines and standards. • Users should don appropriate personal protective equipment (PPE) when processing implants in accordance with the Department of Environment and Occupational Health and Safety’s (OSHA) bloodborne pathogen guidelines. For further information, contact DePuy Synthes Customer Service Department at 1.800.523.0322.

Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA 19380

Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132

To order (USA): 800-523-0322 To order (Canada): 800-946-8999

Form (Non-PPE) | 103509581 | Rev. 2 | Ref: W-D-S072

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