Spine Cleaning, sterilization, inspection and maintenance of reusable medical devices Instructions

Table of contents

1. Introduction ... 3 Warning and precautions ... 4 2. Reprocessing overview ... 5 3. Preparation for cleaning ... 6 4. Manual cleaning ... 7 Pre-cleaning ... 7 Cleaning... 8 5. Automated cleaning ... 9 6. Inspection ...10 7. Packaging ... 11 8. Sterilization ...12 9. Storage before use ...13 10. References...14

Appendix 1: Instructions for disassembly for cleaning ... 15 Appendix 2: Rigid container compatibility for device sets ... 20 Appendix 3: Rigid container steam sterilization instructions ... 45 Appendix 4: OUS Parameters for sterilization wrap compatibility for Xia 3 sets ... 47 Appendix 5: Extended dry time table ... 48

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1. Introduction

This document is intended to provide detailed instructions for processing non-sterile devices manufactured by the Spine division. All non-sterile devices must be cleaned and sterilized to prepare them for use. This document also gives instructions for inspection to determine when an instrument has reached the end of its serviceable life and must be replaced. This document provides assembly and disassembly instructions for multi-component instruments which must be disassembled prior to cleaning and/or sterilization. Stryker has validated the processes provided in these instructions to be capable of being effective. Equipment, operators, cleaning agents, and procedures all contribute to the efficacy of the processing. The healthcare facility should ensure that the selected processing steps are safe and effective. Alternative methods of processing outside the scope of this document may be suitable for reprocessing; however, these must be validated by the end user. In accordance with ISO 17664, two methods of cleaning the Spine division’s non-sterile devices are provided in these instructions, a fully-manual method (Section 4) and a method using an automated washer-disinfector (Section 5). Whenever possible the automated method should be used. The automated cleaning process is more reproducible and, therefore, more reliable. Additionally, staff are less exposed to the contaminated devices and the cleaning agents used. Whichever method is used, staff should use suitable protective clothing and equipment at all times. In particular, take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product.

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Warnings and precautions

Single use devices must not be reused, as they are not designed to perform as intended after the initial use, unless they are reprocessed by a reprocessor expressly authorized by Stryker. Only then can it be assured that the device is appropriate for reprocessing and that the correct methods of validation are used. Please refer to the device label to identify single or multiple use devices and components. Some device materials may develop changes in mechanical, physical, or chemical characteristics under conditions of repeated use, cleaning and re-sterilization that may compromise the integrity of the design and/or material leading to diminished safety, performance, and/or compliance with relevant specifications. The Spine division’s non-sterile devices are not normally used in surgical procedures where they contact TSE infective tissue (Transmissible Spongiform Encephalopathies) as defined by the World Health Organization (WHO). Therefore decontamination procedures with highly aggressive agents [i.e. sodium hydroxide (NaOH) or sodium hypochloride (NaClO)] are not necessary and, for normal processing, are not recommended because material degradation may occur. The sterilization parameters recommended in this document are not intended and not suitable for inactivation of prions.

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2. Reprocessing overview The sequence of steps required to prepare non-sterile instruments for use are summarized in the chart below. More detailed instructions for each step are given on the following pages. Note: Cleaning and sterilization is required for initial use of devices.

Note: The quality of the water used for diluting cleaning agents and/or disinfectants and for rinsing non-sterile instruments should be carefully considered. Application of freshly prepared purified water/highly purified water or sterile water for rinsing purposes with less than 100 CFU/ml and 0.5 EU/ml is highly recommended. Mineral residues from hard water, as well as higher contamination with microorganisms and endotoxins, can result in staining of the device or prevent effective cleaning and sterilization.

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3. Preparation for cleaning (Point-of-use for all instruments)

Point of use After use (within a maximum of 2 hours post-operatively) remove gross soil using absorbent paper wipes. Intensive rinsing of the reusable device with fluent water or transfer of the medical devices into a bath with an aldehyde-free disinfectant solution is highly recommended. Transport to processing area Avoid mechanical damage by ensuring that heavy devices do not get mixed with delicate ones. Pay particular attention to sharp edges, both to avoid personal injury and prevent damage to the reusable devices. Transport the reusable devices to the point where cleaning is to be performed as soon as practical. If transfer to the processing area is likely to be delayed, consider covering the instruments with a damp cloth to avoid drying of soil.

Caution: Stryker’s trays and cases are intended for transport and storage of re-usable instruments. They are not designed for cleaning and/or disinfection in the fully assembled state. The instruments must be removed from the tray for adequate cleaning results.

Preparation for cleaning Appendix 1 provides specific instructions for instruments that requires disassembly prior to cleaning.

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4. Manual cleaning

Pre-cleaning Remove gross soil using wipes and solution of cleaning agent. Immerse non-sterile device in solution of cleaning agent. Ensure that all surfaces are thoroughly wetted. Use a syringe or pipette to ensure that the cleaning solution reaches all parts of cannulations. Ensure that air is not trapped within features of the device when immersing in the solution. Soak for minimum of 15 minutes. Using suitable soft and/or firm bristle brushes, clean the non-sterile device thoroughly, paying particular attention to rough surfaces, threaded areas, and features where soil may be impacted or shielded from the cleaning process. Use a bottle brush of appropriate diameter and length for cannulations. Ensure that the brush passes the whole length of each cannulation. Operate articulating devices and those with moving parts. Rinse in running water until all traces of cleaning solution are removed. Pay particular attention to cannulations and blind holes, as well as hinges and joints, between mating parts. Visually inspect for any remaining soil and repeat the steps above if necessary. Allow to drain on absorbent paper or transfer immediately to cleaning step.

Caution: Never use metal brushes or steel wool for cleaning.

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4. Manual cleaning

Cleaning Equipment required: • Ultrasonic bath large enough to allow complete immersion of the device. A frequency of 25 – 50 kHz is recommended. Do not exceed the temperature range stated by the detergent manufacturer. • Cleaning agent intended for manual cleaning and suitable for ultrasonic treatment. Do not exceed the concentration specified by the detergent manufacturer. • Suitable brushes or cleaning wires to reach all parts of the device. Caution: Never use metal brushes or steel wool for cleaning. • Syringes (volumes 1 to 50 mL, depending on the size of the channels to be rinsed) • Fresh purified water, highly purified water, or sterile water for rinsing purposes.

Instructions: Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature specified by the detergent manufacturer. Immerse the device completely and activate the bath for minimum of 15 minutes. Using suitable brushes or cleaning wires, clean the device paying particular attention to rough surfaces, threaded areas, and features that may be shielded from the brushing action. Rinse for at least 1 minute in running water until all traces of cleaning solution are removed. Pay particular attention to cannulations, blind holes, hinges, and joints between mating parts. If, after completion of the cleaning step in the ultrasonic bath, encrusted soil remains on the device, the cleaning step must be repeated as described above. Note: The guidance provided by the cleaning agent manufacturer concerning concentrations and temperatures should be followed. If these concentrations and temperatures are exceeded significantly, discoloration or corrosion could occur with some materials. This could also happen if rinsing after cleaning and/or disinfecting is insufficient. For cleaning non-sterile devices, only specifically formulated cleaning agents should be used. As not all cleaning agents may be available around the globe, Stryker does not recommend any specific cleaning agent. The end user should verify the selected cleaning agent is appropriate for use on surgical devices designed for reprocessing.

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5. Automated cleaning and disinfection Equipment required: • Washer-disinfector with demonstrated efficiency (e.g. CE mark or FDA clearance and validated in accordance to ISO 15883), properly installed, qualified, and regularly subjected to maintenance and testing. • Approved thermal rinse/disinfection program (application of at least 5 minutes at 90°C). • Cleaning agent intended for use in washer-disinfector. Do not exceed the concentration and temperature recommended by the detergent manufacturer.

Instructions: Load the devices into the washer-disinfector per required loading configuration. Connect cannulations to the rinsing ports of the washer-disinfector. If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket. Avoid contact between devices as movement during washing could cause damage, and washing action could be obstructed. Arrange devices so that cannulations are not horizontal, and blind holes incline downwards to assist with cleaning and drainage. Articulating devices should be in the open position. Operate the washer-disinfector cycle. Upon completion, unload the washer-disinfector. Visually inspect each device for remaining soil and dryness. If soil remains, repeat the cleaning process. Remaining wetness may be removed with filtered, compressed air or clean, lint-free wipes. If additional drying is required, arrange instruments in a clean area or heat in an oven below 110°C.

Caution: Chemical disinfection programs are not recommended due to the potential for chemical residues to remain on the instruments. These residues could interfere with sterilization efficacy. Caution: The parameters identified in this document are the minimum for effective cleaning and sterilization of our instruments. Use of high pH cleaning solutions will reduce the life of instruments. Stryker recommends using a pH neutralizer to limit damage to instruments, as exposure to high pH is known to strip protective coatings from metals, especially aluminum.

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6. Inspection

Before preparing for sterilization, all devices should be inspected. Generally un-magnified visual inspection under good light conditions is sufficient. All parts of the devices should be checked for visible soil and/or corrosion. Particular attention should be paid to: • Soil “traps” such as mating surfaces, hinges, threaded areas, and flexible shafts. • Recessed features (holes, cannulations, and textured surfaces). • Features where soil may be impacted into the device, such as taps, drills, rongeurs. • Cutting edges should be checked for sharpness and damage. Mating devices should be checked for proper assembly. Instruments with moving parts should be operated to check correct operation; application of medical grade lubricants that are biocompatible per ISO 10993 may be necessary. “Flexible” instruments should be checked for damage to the spiral element.

Note: The life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning, and storage. Great care must be taken of the instruments to ensure that they remain in good working order. Instruments should be examined for wear or damage by physicians and staff in operating centers prior to surgery. The examination shall include a visual and functional inspection of the working surfaces, articulation points, rotating features, hinges, springs, connection mechanisms, mating parts, cutting features, threads, and working tip of all instruments.

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7. Packaging Preparation for sterilization

Commercially available sterilization wrap: Stryker’s tray configurations should be double wrapped according to AAMI/CSR technique. The packaging for terminally sterilized devices should be suitable for steam sterilization and the appropriate grade for the weight of the devices. Additionally, the wrap should be compliant to the following requirements: • AAMI ST79 • ISO 11607 • CE mark • FDA 510(k) clearance for specified sterilization parameters

Rigid container: Stryker has validated steam sterilization of complete device trays with Aesculap SterilContainer System. For a complete list of rigid container compatibility details, reference Appendix 2. For all sterilization packaging configurations, Stryker recommends the use of biological indicators as described in ISO 11138-3 (Geobacillus stearothermophilus) and/or chemical indicators as described in ISO 11140 for proper monitoring of all sterilization cycles. Caution: Stryker has only validated the specific lid/case combinations listed to the parameters listed in Section 8. While other combinations and parameters may be appropriate, the responsibility for validation and evaluation would be on the end-user. Warning: The use of lid/ case/tray combinations in a rigid container system that has not been properly validated in accordance with ISO 17665 may result in the inability to meet the required sterility assurance level (SAL) of 10-6. Note: Instruments may be individually wrapped and sterilized. Specialty devices must be individually wrapped and sterilized.

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8. Sterilization USA The sterilization parameters shown at the right are validated at minimum time and temperature in accordance with ANSI/AAMI ST79 and EN ISO 17665. Steam autoclave (moist heat) sterilization using a pre-vacuum (forced air removal) cycle is recommended. Autoclaves should comply with the requirements of, and be validated and maintained in accordance with, EN 285, EN 13060, EN ISO 17665, and ANSI/ AAMI ST79. Stryker has validated the recommended sterilization cycle for complete non-sterile device cases/ trays. Compatibility with rigid container systems is provided in Appendix 2. Rigid Container Steam Sterilization Instructions for outside USA are provided in Appendix 3.

Caution: These parameters may differ in the instructions for use for some of our systems. However, both parameters have been validated. • Exceptions: Stryker’s AVS ARIA System and AVS AL PEEK Spacer System must not be sterilized using reusable, rigid sterilization containers. These systems shall be sterilized according to the Steam Sterilization with FDA-Cleared/Commercially Available Sterilization Wrap Instructions

Method

Moist heat sterilization according to ANSI/AAMI ST79 and EN ISO 17665

Cycle

Pre-vacuum (dynamic air removal)

Temperature

132oC (270oF)

Exposure time1

4 minutes

Drying time2

45 minutes (minimum, in chamber)

Outside USA Method

Moist heat sterilization according to EN ISO 17665

Cycle

Pre-vacuum (dynamic air removal)

Temperature

134oC (273oF)

Exposure time1

3 minutes (minimum)

Drying time2

45 minutes (minimum, in chamber)

Caution: Stryker does not recommend the use of ‘flash’ sterilization for non-sterile devices. Caution: Longer cycles, such as those recommended for control or elimination of Transmissible Spongiform Encephalopathies, may be utilized; however, instruments should be expected to have reduced functional life.

Warning: Implants and instruments which are supplied sterile must not be re-sterilized as this process has not been validated. 1 Exposure time: Period for which the load and entire chamber is maintained at the sterilization temperature. 2 Drying time: Period during which steam is removed from the chamber and the chamber pressure is reduced to permit the evaporation of condensate from the load either by prolonged evacuation or by the injection and extraction of hot air or other gases. The drying time varies due to load configuration, wrapping method, and material. Therefore, dry time may be repeated if moisture is present on the wrap and/or instruments.

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9. Storage before use

After sterilization, devices should be stored in the sterilization wrap or rigid container in a dry and dust-free place. The shelf life is dependent on the sterile barrier employed, storage manner, environmental conditions, and handling. A maximum shelf life for sterilized devices should be defined by each health care facility based on the recommendations of the wrap or container manufacturer.

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10. References

1. AAMI TIR 12: Design, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: a guide for medical device manufacturers 2. AAMI TIR 30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices 3. ANSI/AAMI ST 77: Containment devices for reusable medical device sterilization 4. ANSI/AAMI ST 79: Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities 5. EN 285: Sterilization - Steam sterilizers - large sterilizers 6. EN 13060: Small steam sterilizers 7. ISO 11607-1: Packaging for terminally sterilized medical; devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems 8. ISO 15883-1: Washer-disinfectors - Part 1: General requirements, terms and definitions, and tests 9. ISO 17664: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices 10. ISO 17665-1: Sterilization of healthcare products, moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices 11. ISO 17665-2: Sterilization of health care products, moist heat - Part 2: Guidance on the application of ISO 17665-1

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Appendix 1: Instructions for disassembly for cleaning

Part number

Instrument name

Surgical system

Steps

Instructions

48805090

Quick Turn Screwdriver

Anterior Cervical Plate System (ACP)

1

Unthread inner shaft and remove

Part number

Instrument name

Surgical system

Steps

Instructions

48921011 48921013 48921015 48921017 48921019 48921100

Guide Assembly (11mm, 13mm, 15mm, 17mm, 19mm) Inserter Guide Inner Shaft Aero-AL

1

Pull inner shaft from the main body of the device

48921005 48921050

Revision Guide Revision Guide Inner Shaft

Part number

Instrument name

Surgical system

Steps

Instructions

49177240

Rescue Screwdriver

LITe Plate System

1

Unthread draw rod from outer shaft and remove

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Appendix 1: Instructions for disassembly for cleaning

Part number

48280178 48280179 48280180 48280181 48280182 48280183

Instrument name

Ratchet Knob Adjustable Arm Distraction Shaft 2 Level Rack 4 Level Rack Fixed Arm

Surgical system

Steps

Instructions

1

Put the latch on the compression/ distraction mechanism in the unlock position

2

Slide the Adjustable Arm off of the rack

3

Remove the Ratchet Knob from the compression/distraction mechanism by firmly pulling on the knob straight back and away from the instrument

ES2

4

Press the lever on the Fixed Arm into the “unlock” position and slide the Fixed arm off of the rack. Note: The outer sleeve of the arms should be in the locked, neutral position for cleaning.

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Part number

48280310

Instrument name

Polyaxial Screwdriver

Part number

Instrument name

48562018

Polyaxial Screwdriver with optional outer sleeve

Surgical system

ES2

Surgical system

Pull out Distraction Knob

Steps

Instructions

1

Release the quick connect handle from the Screwdriver shaft Adapter

2

Remove the Screwdriver Adapter by pressing the “unlock” button on the Locking Nut

3

Remove the inner sleeve by sliding it through the bottom of the outer shaft

Steps

Instructions

1

Press button on optional outer sleeve (tissue sleeve)

2

Slide outer sleeve off of shaft

Oasys

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Appendix 1: Instructions for disassembly for cleaning

Part number

482397004

Instrument name

Low Profile Screwdriver

Part number

Instrument name

48261330 48261330S

Polyaxial Screwdriver, Polyaxial Screwdriver, Short

Surgical system

Xia Elegance

Surgical system

Xia 3 - Serrato

Steps

Instructions

1

Release the quick connect handle from the Screwdriver shaft Adapter

2

Remove the Screwdriver Adapter by pressing the “unlock” button on the Locking Nut

3

Remove the inner sleeve by sliding it through the bottom of the outer shaft

Steps

Instructions

1

Slide the Screwdriver Connect Adaptor off of the main shaft

2

Press button to slide off the locking nut

3

Press outer sleeve button to slide outer sleeve off of shaft

Part number

Instrument name

Surgical system

Steps

Instructions

48235001

Lateral Persuader

Xia 3

1

Unthread the threaded shaft and completely pull out the center tube from the lateral persuader

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Appendix 1: Instructions for disassembly for cleaning

Part number

Instrument name

48231330 482391330S 482391330L 48231320 482391320S 482391320L

Polyaxial Screwdriver Polyaxial Short Screwdriver Polyaxial Long Screwdriver Monoaxial Standard Screwdriver Monoaxial Short Screwdriver Monoaxial Long Screwdriver

Xia (3 and Elegance)

Part number

Instrument name

Surgical system

482331330

Part number

48856006 48138012 48138013

Uniplanar Screwdriver Reduction

Instrument name

Cannulated Screwdriver Shaft Screwdriver Outer Sleeve Screwdriver Locking Nut

Surgical system

Xia 3

Surgical system

Xia 4.5 Xia CT

Steps

Instructions

1

Release the quick connect handle from the quick connect mechanism

2

Slide the Screwdriver Connect Adaptor off of the main shaft

3

Slide outer sleeve off of shaft

Steps

Instructions

1

Release the quick connect handle from the quick connect mechanism

2

Slide the Screwdriver Connect Adaptor off of the main shaft

3

Slide outer sleeve off of shaft

Steps

Instructions

1

Release the quick connect handle from the quick connect mechanism

2

Slide the locking nut off of the main shaft

3

Slide outer sleeve off of shaft

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Appendix 1: Instructions for disassembly for cleaning

Part number

Instrument name

Surgical system

Steps

Instructions

1

Turn the TL Steerable Inserter rotating tip into the straight position and press the release button. The TL Steerable Inserter Inner Shaft will slide out.

If there is difficulty removing the inner shaft proceed with steps 2 and 3.

48930000 48930005 48930013

Part number

Tritanium TL Steerable Inserter Tritanium TL Steerable Inserter Inner Shaft TL Steerable Inserter Driver

Instrument name

2

Use the inserter driver to push the side button and release the inner shaft. Turn the inserter upside down and the inner shaft will slide out.

3

If the inner shaft does not immediately slide out when the side button is pressed, spin the back (proximal) locking knob at the same time as pressing the side button.

4

If difficulty is still encountered, use both drivers in the set. Thread one of the drivers into the back (proximal) end of the inner shaft to pull the shaft out and simultaneously use the second inserter driver to press the side button.

Steps

Instructions

Tritanium TL

Surgical system

1

Remove draw rod knob (if necessary)

2

Unlock black rotation wings (if necessary). Rotate distal tip of device to straight and remove draw rod.

3

Pinch pawls of inserter and pull out syringe plunger (rotate the plunger counter clockwise if necessary)

4

Remove o-ring from syringe plunger (discard if damaged)

5

Use pressure gauge knob to rotate pressure gauge counter clockwise until it loosens and can be pulled out

6

Remove o-ring from pressure gauge and discard

7

Remove tube set from inserter and discard

Tritanium X TL Inserter 580220100 580220101 680220102 680220100 680220104 680220109 680220108

(fully assembled with the following accessories)

TL Inserter Draw rod Syringe Plunger Tube Set Pressure gauge Draw rod knob Pressure gauge knob (not assembled but needed for disassembly)

Tritanium X

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Appendix 2: Rigid container compatibility for device sets Stryker has validated steam sterilization of complete, fully loaded non-sterile device trays with Aesculap’s SterilContainer System. Other rigid container systems may be suitable for use, but must be evaluated by the end-user. Refer to Aesculap Instructions for Use for Care & Handling of Aesculap SterilContainer Systems. • Exceptions: Stryker’s AVS ARIA System and AVS AL PEEK Spacer System must not be sterilized using reusable, rigid sterilization containers. These systems shall be sterilized according to the Steam Sterilization with FDA-Cleared/Commercially Available Sterilization Wrap Instructions Aero-AL

Instrument Tray 1: 4892200 Instrument Tray 2: 4822001

Aero-C

Instrument Container: 48890000

Aero-LL

Instrument Container: 48940000

ES2 Augmentable

Brand name

IBD PEEK C

LITe

Alignment Guide: 48491301 Hex Handle: 48491302 Monoaxial ScrewDriver Inner Shaft: 48491304 Monoaxial Screwdriver: 48491303 Instrument Container: 48808200A LLIF Implant Container: 49179000 ALIF Implant Container: 49179100 Buttress Plate Container: 49179102 Plating Instrument Container: 49179200

Tritanium C

Instrument Container: 48980001

UniVise

Instrument Container: 48590000

Anterior Cervical Plate System (ACP)

Instrument Container: 48805200

Tritanium TL Navigation Enabled Instruments Tritanium X

Instrument Container: 48930001 Posterior Trials Instrument Container: 48930002 Navigation Enabled XIA and ES2 Instruments: 48706501 Navigation Enabled Serrato Instruments: 48706502 Posterior TLIF Disc Prep 1 Instruments: 680220002 Posterior TLIF Disc Prep 2 Instruments: 680220003

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