Bone Instrument Sterilization Guide

Cleaning and Sterilization Guide for Implants, Instruments, and Accessories

Medical Device Cleaning Groups
For proper handling during cleaning, reusable Stryker Leibinger devices are classified into six groups. Some instruments may belong to more than one group. In this case, the cleaning method should be the most aggressive or combine the instructions outlined for each corresponding group. If an instrument is not included in the list below and you are in doubt about the cleaning group it belongs to, refer to the Instructions For Use supplied with the instrument. Contact Stryker Leibinger Customer Service for clarification purposes. See contact information below.*
Group Description Representative Product Samples
I Basic
one-piece devices(with no moving or detachable part),
devices that do not cut, scrape or pierce bone, non-cannulated, non-articulated devices
one-piece screwdrivers, spatulae, femoral clamps, screwdriver blades, one-piece cheek retractors, fixation plates, non-articulated forceps, one-piece hooks, probes, one-piece tongue depressors, mirrors, suture pushers, tissue picks, rulers, ligature guides, retractor blades, mallets, guide wires, forks, cotton applicators, ear loops, one-piece mouth gags, one-piece mouth openers, mouth props, scalpel handles, strippers, one-piece wiring instruments, arch bars, etc.
one-piece plates, etc.
II (Bone) Cutting
devices that cut, pierce or scrape
countersinks, drill bits, taps, osteotomes, bone elevators, curettes, spoons, dissectors, knives, scissors, raspatories, rasps, needles, awls, ear loops, perforators, chisels, scalpels, gouges, pluggers, saw blades, burrs, cutters, separators, cutting cylinders osseous microtome, trephines, trocars, plate deburrers,etc.
one-piece screws, one-piece fixation pins, etc.
III Cannulated
cannulated devices (with cannula or features whose diameter is less,
than or equal to 1/6 of the device‘s length)
drill/pin guides and sleeves, trocars, speculae, ear syringes, cannular gauges, cannulae, fixation sleeve, insertion tool, suction tubes, guiding tubes, catheters, tubes, suction dissectors, etc.
cannulated screws, cannulated fixation pins, etc.

IV Articulated and Multi-Component
articulated devices and those consisting of at least two pieces (with moving or detachable parts)
articulated bone forceps, articulated tissue forceps, roller benders, clamps, multi-component retractors, biopsy probes, screwdriver handle, haematom evacuators, needleholder, suture forceps, drill handle, multi-component hooks, probes, multi-component tongue depressors, multi-component mirrors, coagulation instruments, measuring instruments, depth measuring gauges, fascia applicators, razor blade holders, rongeurs, ear snare, bone punches, spreaders, osseous microtome, multi-component or articulated wiring instruments, hand traction system, lag screw target bow, etc.
bone distractors, multi-component screws, multi-component plates, etc.
V Flexible
devices with flexible shaft, cables
electrodes (TC string electrodes, TC straight, electrodes, TC needle electrodes, TC electrodes), and connecting cables, IM reamers, fiber optic cables, etc.
distraction rods, etc.
VI Storage/Sterilization Boxes, Trays
instrument containers
implant modules, sterilization trays, screw
holders, sterilization containers, instrument trays, etc.

Clean devices before first and every use and before returning them to service.
After cleaning, sterilize as directed prior to use.
• Only trained personnel should treat devices as instructed in this manual.
• Handle sharp-edged and pointed instruments with care
• Do not place contaminated devices in containers.
• Use protective garments as recommended in the
instructions supplied with the cleaning agent.
• Whenever possible, disassemble the device and/or loosen all connections prior to treatment. Open hinged/jointed devices as recommended. Refer to the Instructions For Use supplied with the device.
• Ensure the devices are completely immersed in the cleaning solution.
• To avoid higher risk of corrosion and contamination, treat devices immediately after use.
• To avoid contamination and to prevent debris from drying out, transport devices to the cleaning area, covered with a damp cloth or closed in a heat-sealed bag.
• For proper cleaning, use preferably a protease-based cleaning agent. Refer to Appendix 1.
• Depending on the conditions of use, replace the cleaning solution daily or more frequently. Dirt accumulation and increased concentration due to evaporation may compromise cleaning effectiveness and risk of corrosion.
• For proper loading of the washing machine, follow the instructions contained in this manual and the manufacturer’s recommendations. Avoid overloading to ensure that all surfaces are reached by the cleaning solution.
• Strictly follow the dosage, temperature, exposure time, material compatibility specifications and, after use, disposal restrictions of the cleaning agent as recommended by the manufacturer.
• If medical compressed air is used, a sterile filter must be available.

• To avoid product damage (pitting, rust, degradation), DO NOT use highly aggressive agents (NaOH, NaOCL), salt solutions and other unsuitable cleaning agents.
• To avoid surface discoloration or stains, dissolve powders completely if used as cleaning agents.
• Use suitable cleaning tools as instructed in this anual. Never use metal brushes or metal sponges for debris removal.
• Rinse thoroughly and carefully. If agents lacking a foam inhibitor are used, take care to remove foam during rinsing. Sterile demineralized water facilitates water spots removal from the surface.
3.2.3. Caution Notes for Instruments
with Electronics CAUTION
• DO NOT immerse instruments/cables. If water runs into the battery holder or enters the housing, the electronics can fail and the communication with the system will cease.
• To avoid malfunction of the instrument, DO NOT scratch or damage the Light Emitting Diodes (LEDs) or the transceiver cover. Check them for proper functioning after cleaning. See Instructions For Use supplied with the device.
• DO NOT use solvents, lubricants, or other chemicals unless otherwise specified.
• DO NOT use aggressive or scouring agents, or other chemicals.
• Use a neutral enzymatic cleaner

Cleaning Methods
Both manual and machine cleaning methods can be used. Whenever possible, the washing machine should be used to avoid prolonged contact with contaminated devices and the cleaning agents.
3.4. Cleaning Equipment
Manual Cleaning (and Pre-cleaning Stage Prior to Machine Cleaning)
Protective Garments:
• Single use shirt
• Single use gloves
• Safety glasses
• Anti-splash mask (see recommendations supplied with cleaner)
Material Equipment:
• Sterile purified water
• Running water
• Appropriate cleaning agent (Appendix 1)
• Soaking pans (preferably stainless steel):
Vol. 500 ml at 25 l capacity
• Ultrasound bath with adjustable temperature and stainless steel basket (Frequency: 25-50 kHz, min. Power: 238 W), large
enough for complete immersion of all devices intended to be cleaned
• Sterile syringe (approx. Vol. 50 ml)
• Single use drying paper
• Medical compressed air
• Thermometer
• Suitable cleaning tool as follows:

Group Cleaning Tool Note

I Supple (soft) polishing brush
Diameter and length depending on device
II Hard (nylon) bristle brush
Choose appropriate diameter. Carefully clean cutting
III Flexible bottle brush
Choose appropriate diameter. Scrub the inside of
the cannulae repeatedly.
IV Syringe for solution injection into hard-to- reach parts
Use only sterile tools and syringe.
Take care to clean articulated parts.
V Brush with fine stiff bristles
Choose appropriate size. Scrub flexible parts.
VI. Supple polishing brush
Choose appropriate size. Pay attention to
and bottle brush holes and slots.




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