Stryker
Cleaning and Sterilization Guides
Cleaning, Sterilization, Inspection for Osteosynthesis Medical Devices L24002000
Instructions
32 Pages
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Page 1
Instructions for Cleaning, Sterilization, Inspection and Maintenance of Osteosynthesis Medical Devices
Contents 1. Introduction Warnings and Precautions 2. Processing Instructions 3. Cleaning Inspection Packaging 4. Sterilization 5. Storage before Use 6. References 7. Manufacturers of Stryker Osteosynthesis Medical Devices
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Page 3 3 4 5 8 8 9 11 11 11
Appendix 1 Cleaning agents and disinfectants used during validation of the processing instructions
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Appendix 2 Generic product groups defined for the cleaning validation
13 13
Appendix 3 Guidelines to check proper functionality of the medical devices
16 16
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1. Introduction
This document is intended to give general guidance on how medical devices supplied by one of the Stryker Osteosynthesis manufacturing locations (see manufacturer addresses in section 7) may be processed to prepare them for use. It also gives instructions for inspection to determine when an instrument has reached the end of its serviceable life and must be replaced. This document is provided in conjunction with the assembly and disassembly instructions for multi-component instruments which must be disassembled prior to cleaning and the instructions for use which come with the products. Stryker Osteosynthesis has demonstrated the processes described in these instructions to be capable of being effective.
Equipment, operators, cleaning agents and procedures all have a contribution to the efficacy of the processing and the healthcare facility should ensure that the combination actually in use results in a medical device which is safe for use. Alternative methods of processing may be equally suitable. In the event of conflicting national cleaning and sterilization requirements, these shall prevail over Stryker Osteosynthesis' recommendations. This applies particularly to the different procedures for inactivation of prions.
Warnings and Precautions •
•
•
Devices labeled “for single use must not be reprocessed only” for re-use. When single use devices are supplied non-sterile and require sterilization before use, the appropriate sections of these instructions may be applied unless other specific instructions are provided in the package insert. Single use devices must not be reused, as they are not designed to perform as intended after the first usage. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization release. Stryker Osteosynthesis medical devices are not normally used in surgical procedures where they contact low or high risk TSE
(Transmissible Spongiform Encephalophaties) infective tissue as defined by World Health Organization (WHO), Robert Koch Institute (RKI) etc.. Therefore decontamination procedures with highly aggressive agents [i.e. sodium hydroxide (NaOH), sodium hypochloride (NaOCl)] 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. Processing Instructions The sequence of steps required to prepare medical devices for re-use or to prepare new devices for initial use are summarized in the chart below. More detailed instructions for each step are given on the following pages.
Point of Use
Remove gross soil Rinse in running water Place in aldehyde-free disinfectant bath
Transport to Processing Area
Avoid mechanical damage Minimize time before cleaning
Preparation for Cleaning
Disassemble where possible
Remove gross soil Soak in cleaning solution Brush, operate moving parts Rinse in running water Inspect, place on absorbent paper
Pre-Cleaning
Manual
Manual Cleaning and Disinfection
Automatic (recommended)
Soak in ultrasonic bath Clean with brushes or cleaning wires Rinse with syringe/running water Soak in disinfectant solution Clean with brushes Rinse with syringe/running water Dry (compressed air/wipes/oven)
Automated Cleaning and Disinfection in Washer-Disinfector
Load into washer-disinfector Connect cannulations to rinsing ports, arrange products Operate washer-disinfector cycle Inspect, dry
Inspection
Visual inspection Functional check
Packaging
Store devices in dedicated trays or wire baskets Single or double packaging
Sterilization
Steam autoclave
Storage
Control environment Control shelf life
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3. Cleaning Two methods of cleaning Stryker Osteosynthesis medical devices are provided in these instructions, a manual method and a method using an automated washer disinfector. Whenever possible the automated method should be used. The automated cleaning process is more reproducible and therefore more reliable, and 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. The guidance concentrations and times for device immersion in the cleaning solutions and/or disinfectants given by the detergent manufacturers shall be observed. If these concentrations and times 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 or disinfecting medical devices only specifically formulated cleaning agents and/or disinfectants (detergents) should be used. As not all cleaning agents and disinfectants may be available around the globe, criteria for the selection of appropriate detergents are provided in Appendix 1. A list of cleaning agents and disinfectants which Stryker Osteosynthesis used in the validation of these processing instructions is also provided in Appendix 1. Stryker Osteosynthesis does not recommend any specific cleaning and/or disinfection agent. A general description of suitable agents is included in Appendix 1.
Preparation for cleaning
Directly after application (within a maximum of 2 hours postoperatively) remove gross soil using absorbent paper wipes. Additionally, intensive rinsing of the medical devices with fluent water or transfer of the medical devices into a bath with an aldehydefree disinfectant solution meeting the criteria given in Appendix 1 is highly recommended.
Disassemble the device where possible. See instructions provided in the operative technique or separate information available from your Stryker representative.
Avoid mechanical damage, e.g. do not mix heavy devices with delicate ones. Pay particular attention to cutting edges, both to avoid injury and damage to the medical device. Get the medical 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 medical devices with a damp cloth or store the medical devices in closed boxes to avoid drying of soil.
Caution: Stryker Osteosynthesis trays are intended for sterilization, transport and storage of medical devices. They are not designed for cleaning and disinfection in the fully equipped state. The devices must be removed from the tray for adequate cleaning results.
The quality of the water used for diluting cleaning agents and/or
Point of use
Transport to processing area
disinfectants and for rinsing medical devices should be carefully considered. Application of freshly prepared purified water/highly purified water or sterile water for rinsing purposes (according to the pharmacopeias) with less than 10 cfu/ml and 0.25 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 decontamination.
•
Pre-Cleaning
• Remark: The pre-cleaning step can be ommitted in case of direct subsequent manual cleaning and disinfection. In case of highly contaminated medical devices to be subjected to an automatic cleaning process, pre-cleaning in an ultrasonic bath is recommended. Equipment required: • Cleaning bath or vessel large enough to allow complete immersion of the instruments. • Freshly prepared cleaning solution using a cleaning agent intended for manual cleaning which meets the 5
• •
criteria given in Appendix 1, with concentration, temperature, and soaking time not less than specified in the detergent manufacturer´s instructions (but temperature not exceeding 50 °C) Brushes – soft and firm, bottle brushes or cleaning wires for cannulations etc. Personal protective equipment as recommended by the cleaning agent supplier (minimum overalls, gloves, face/eye shield) Absorbent paper Syringes (volumes 1 to 50 ml depending on the size of the cannulations to be rinsed)
Caution: Never use metal brushes or steel wool for (pre-) cleaning.
3. Cleaning
Procedure • Remove gross soil using paper wipes and solution of cleaning agent. • Immerse medical device in solution of cleaning agent. • Ensure that all surfaces are thoroughly wetted, using a syringe to ensure that solution reaches all parts of cannulations etc. Ensure that air is not trapped within features of the device when immersing in the solution. • Soak at minimum for the time recommended by the detergent manufacturer´s instructions.
•
•
•
Using suitable brushes (only soft brushes, never metal brushes or steel wool) or cleaning wires clean the medical device thoroughly paying particular attention to rough surfaces and features where soil may be shielded from the brushing. Use a firm bristle brush for cleaning bone-cutting features such as drill tips, reamer flutes and the teeth of broaches. Use a bottle brush of appropriate diameter for cannulations. Ensure that the brush passes the whole length of each cannulation at least three times.
• •
•
•
•
Operate articulating devices and those with moving parts. Rinse in running water for at least 1 min 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. At least three times complete rinsing by application of a syringe (volume 1-50 ml) is required. 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.
Manual cleaning and disinfection
Caution: Combined cleaning and disinfection procedures are only recommended in case of medical devices which are contaminated to an extremely little extent.
•
•
Cleaning
or cleaning wires (for small channels) to reach all parts of the device. Syringes (volumes 1 to 50 ml depending on the size of the channels to be rinsed) Freshly prepared purified water/ highly purified water or sterile water for rinsing purposes. •
Equipment required: • Ultrasonic bath large enough to allow complete immersion of the medical device. Frequency 25 – 50 kHz, temperature according to detergent manufacturer`s instructions. • Cleaning agent intended for manual cleaning and suitable for ultrasonic treatment which meets the criteria given in Appendix 1; concentration as specified in detergent manufacturer’s instructions. • Suitable brushes (only soft brushes, never metal brushes or steel wool)
Procedure: • Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature specified in the detergent manufacturer´s instructions. • Immerse the device completely and activate the bath for at least the time specified in the detergent manufacturer´s instructions. • Using suitable brushes (only soft brushes, never metal brushes or steel wool) or cleaning wires (for small channels) clean the device
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•
paying particular attention to rough surfaces and features that may be shielded from the brushing action. Additionally, pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts. Rinse cannulations at least three times with a syringe. Rinse for at least 1 min in running water of the specified quality 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. Rinse cannulations at least three times with a syringe (volume 1-50ml). If, after completion of the cleaning step in the ultrasonic bath, encrusted soil remained on the device which had to be removed with the brush, the cleaning step must be repeated as described above.
3. Cleaning Disinfection
Equipment required: • Bath large enough to allow complete immersion of the medical device, temperature according to detergent manufacturer`s instructions. • Disinfectant intended for manual disinfection and compatible with the applied cleaning detergent which meets the criteria given in Appendix 1; concentration according to the detergent manufacturer’s instructions. • Syringes (volumes 1 to 50 ml depending on the size of the channels to be rinsed). • Freshly prepared purified water/ highly purified water or sterile water for rinsing purposes. • Filtered medical compressed air (if available) or clean and lint-free single use wipes.
Procedure: • Prepare a bath with a disinfectant solution at the concentration and temperature specified in the detergent manufacturer´s instructions. • Immerse the device completely for at least the time specified in the detergent manufacturer´s instructions. • Rinse cannulations at least three times with a syringe. • Rinse for at least 1 min in running water of the specified quality until all traces of disinfectant solution are removed. Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts. Rinse at least five times with a syringe (volume 1-50ml).
•
•
Dry the medical device using medical compressed air and clean and lint-free single use wipes (if required supplemented by postdrying at a clean place for up to 2 hours) or by heating in an oven below 110°C. Visually inspect and repeat complete manual cleaning and disinfection if necessary.
Automated cleaning and disinfection using washer-disinfector (recommended)
Equipment required: • Washer-disinfector with fundamentally approved efficiency (e.g. CE mark or FDA approval according to ISO 15883), properly installed, qualified and regularly subjected to maintenance and testing • Approved thermal disinfection program (A0 value > 3000 or – in case of older devices – application of at least 5 min at 90 °C; chemical disinfection program not recommended due to danger of remnants of the disinfectant on the instruments) with sufficient rinsing steps and filtered air for an active drying program (application of rinsing aids not recommended, danger of remnants) • Final rinsing/disinfection only with freshly prepared purified water/ highly purified water • Cleaning agent intended for
automated cleaning which meets the criteria given in Appendix 1, concentration as specified in the detergent manufacturer’s instructions. Procedure: • Load the medical devices into the washer-disinfector. • 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 (movement during washing could cause damage, and washing action could be obstructed). • Arrange medical devices so that cannulations are not horizontal and blind holes incline downwards (to assist drainage).
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• • •
Articulating devices should be in the open position. Operate the washer-disinfector cycle. On completion unload the washerdisinfector. Visually inspect each device for remaining soil and dryness. If soil remains repeat the cleaning process including the precleaning stage. Remaining wetness may be removed with medical grade compressed air, clean and lintfree single use wipes (if required supplemented by post-drying at a clean place for up to 2 hours) or by heating in an oven below 110°C.
3. Cleaning Inspection Before preparing for sterilization, all medical 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, shafts of flexible reamers. • Recessed features (holes, cannulations). • Features where soil may be pressed into contact with the device, e.g. drill flutes adjacent to the cutting tip, sides of teeth on broaches and rasps. • Cutting edges should be checked for sharpness and damage. • For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves. *
Functional checks should be performed where possible: • Mating devices should be checked for proper assembly. • Medical devices with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam sterilization can be applied as required). • Rotating instruments (e.g. multiple use drill bits, reamers) should be checked for straightness (this can be achieved by simply rolling the instrument on a flat surface). • “Flexible” instruments, e.g. IM reamers, should be checked for damage to the spiral element.*
Note: Stryker Osteosynthesis usually does not define the maximum number of uses appropriate for re-usable medical devices. The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device. However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date. See Appendix 3 for further details.
Packaging Where appropriate the cleaned, disinfected, and checked medical devices should be assembled into the dedicated trays provided. Stryker Osteosynthesis cases/trays should be double wrapped according to AAMI/CSR technique. The packaging for terminally sterilized medical devices should fulfill the following requirements: • EN ISO 11607 • Suitable for steam sterilization (temperature resistance up to at least 141 °C, sufficient steam permeability) • Sufficient protection of the instruments as well as of the sterilization packagings to mechanical damage
* See Appendix 3 for further inspection instructions.
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4. Sterilization
Caution: Medical Devices containing thermolabile materials must not be exposed to additional loads in the autoclave!
USA*
Method Cycle Temperature
Steam sterilization (moist heat) is recommended. An autoclave cycle has been validated by Stryker as being capable of achieving sterile medical devices; however autoclave design and performance can affect the efficacy of the process. Healthcare facilities should validate the process that they use, employing the actual equipment and operators that routinely process the devices.
Moist heat sterilization Pre-Vacuum (Pre-Vac) 270°F (132°C)
Exposure Time1 4 minutes Pressure
2-15 PSIA
Drying Time²
30 minutes (minimum, in chamber)
Cool Time
60 minutes (minimum, at room temperature)
Outside USA* Sterilization process
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, maintenanced and checked in accordance with EN 285/EN 13060, EN ISO 17665, and ANSI AAMI ST79. Stryker has validated an autoclave cycle for sterilization of complete medical device cases/trays. Instruments shall be sterilized in the mounting condition as stored on the tray, i.e. if the brackets or recessions in the tray are designed to accomodate multi-component instruments in their assembled state, there is no need to disassemble these instruments for sterilization. The process parameters shown on the right are validated and recommended by Stryker Osteosynthesis for sterilization:
Method Cycle
Moist heat sterilization according to EN ISO 17665 Saturated steam with fractional forced air removal
Exposure Time1
4 minutes Exposure time can be extended to 18 minutes to comply with the recommendation from World Health Organization (WHO), Robert Koch Institute (RKI) etc. Stryker Osteosynthesis medical devices are able to sustain such sterilization cycles.
Temperature
132-137°C (270-277°F)
Drying Time²
recommended: 30 minutes (minimum, in chamber)
1 E xposure time:
Period for which the load and entire chamber is maintained at the sterilization temperature ² D rying 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. It is the hospital´s responsibility to validate the appropriate drying time with the sterilization equipment used.
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4. Sterilization
Please note that according EN ISO 17665 the final responsibility for validation of sterilization techniques and equipment lies directly with the hospital. To ensure optimal processing all cycles and methods should be validated for different sterilization chambers, wrapping methods and/or various load configurations.
* Caution: These parameters are not applicable to the entire Stryker Osteosynthesis portfolio. There are exceptions for which other validated sterilization cycles are applicable. These are described in the instructions for use and have binding character. If a product is supplied without a package insert and if you are in doubt about the applicable sterilization parameters for a particular product, please contact the manufacturer. Manufacturer addresses are provided in section 7.
Alternative (e.g. UK, NL)*
Method
Moist heat sterilization according to EN ISO 17665
Cycle
Saturated steam with fractional forced air removal
Exposure Time1 3 minutes Exposure time can be extended to 18 minutes to comply with the recommendation from World Health Organization (WHO), Robert Koch Institute (RKI) etc. Stryker Osteosynthesis medical devices are able to sustain such sterilization cycles Temperature
134°C-138°C (273°F-280°F)
Drying Time²
recommended: 30 minutes (minimum, in chamber)
1 E xposure time:
Period for which the load and entire chamber is maintained at the sterilization temperature ² D rying 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. It is the hospital´s responsibility to validate the appropriate drying time with the sterilization equipment used.
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5. Storage before Use
After sterilization, please store the medical devices in the sterilization packagings in a dry and dust-free place. The shelf live is depending on the sterile barrier employed, storage manner, environmental and handling conditions. A maximum shelf life for sterilized medical devices before use should be defined by each health care facility.
6. References (partly relevant for some countries only) 1.
2.
EN ISO 11607 (ANSI AAMI ISO 11607): Packaging for technically sterilized medical devices (replaced EN 868-1 and ISO 11607)
5.
EN ISO 17665 (ANSI AAMI ISO 17665): Sterilization of health care products, moist heat (replaced EN 554 and ISO 11134)
World Health Organization (WHO) and Robert Koch Institute (RKI) recommendations regarding exposure time: WHO/CDS/CSR/APH/2000.3, Annex III, section 2, 6. RKI Communication in "Bundesgesundheitsblatt", April 2002, 45:376-394, table 11
8.
9.
Stryker steam sterilization validation study; Summary report, H. Davis, September 2001 Stryker Trauma GmbH validation report VAL P0011, VAL P0014
10. Stryker Orthopaedics Technical Report T-878 11. Stryker Osteosynthesis Ti2078-09
3.
4.
ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities EN ISO 17664 (ANSI AAMI ST81): Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices
6.
7.
Verbund für angewandte Hygiene e.V. (VAH) DesinfektionsmittelListe, (VAH List of Disinfectants, replaced the DGHM List of Disinfectants) Internal validation reports, not for public use
12. Stryker Osteosynthesis Ti2381-09
Stryker cleaning / decontamination validation study; Summary report, H. Davis, November 2001
7. M anufacturers of Stryker Osteosynthesis Medical Devices Stryker Trauma GmbH Prof.-Küntscher-Str. 1 - 5 D-24232 Schönkirchen Germany phone: +49-4348-702 0 fax: +49-4348-702 172
Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland phone: +41-32-641 6666 fax: +41-32-641 6660
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Stryker Leibinger GmbH & Co KG Boetzinger Str. 41 D-79111 Freiburg Germany phone: +49-761-4512 0 fax: +49-761-4512 120
Appendix 1 Cleaning agents and disinfectants used during validation of the processing instructions For cleaning and/or disinfection of medical devices manufactured from aluminium alloys a pH neutral agent should be used*. Contact with strong alkaline detergents or solutions containing iodine or chlorine should be avoided, since the aluminium can be chemically attacked and the instrument may be damaged. For automatic (washer-disinfector) cleaning mild alkaline agents (up to pH 10.9) should be preferred, however use only agents recommended for use in these machines.
In all cases • follow the indications, instructions and warnings provided by the supplier of the cleaning agent and/ or disinfectant, • select only detergents intended for cleaning and/or disinfection of medical devices made of metals and plastics, and • select only disinfectants with approved efficiency (VAH/DGHM or FDA approval or CE mark).
Ensure that the substances listed below are not ingredients of the cleaning or disinfection detergent chosen: • organic, mineral, and oxidizing acids (minimum admitted pH-value 5.5) • strong lyes (maximum admitted pH-value 10.9*) • organic solvents (for example: acetone, ether, alcohol, benzine) • oxidizing agents (for example: peroxides, hypochloride) • halogens (chlorine, jodine, bromine) • aromated, halogenated hydrocarbons.
Notes: • The cleaning agents listed below were used by Stryker Osteosynthesis when validating the instructions for processing provided in this document. • Stryker Osteosynthesis does not recommend these products in preference to others that are available. Other products may perform equally or better in conjunction with the equipment being used. • The instructions provided by the supplier of the detergents should be followed.
• Personal protection for operators should be provided in accordance with the suppliers instructions and safety data sheets Suitability of alternative agents should be checked by reference to the supplier’s information and/or physical testing.
•
Agents for pre-cleaning and manual cleaning (used for validation)
Supplier
Designation
Comment
Johnson and Johnson Cidezyme/Enzol
Suitable for aluminium instruments
Agents for manual disinfection (used for validation)
Supplier
Designation
Comment
Johnson and Johnson
Cidex OPA
Suitable for aluminium instruments
Agents for automatic cleaning/disinfection in a washer disinfector (used for validation)
Supplier
Designation
Comment
Dr. Weigert
Neodisher Mediclean forte
Not recommended for aluminium medical devices*
* In case of aluminium instruments neutral/enzymatic detergents are recommended (for example Neodisher Medizym)
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Appendix 2 Generic product groups defined for the cleaning validation For cleaning and sterilization validations, Stryker Osteosynthesis usually applies a "worst case" approach, i.e. the most challenging products are selected as representative test samples. For the cleaning validation we defined the following generic product groups: Group I
One piece instruments
Group I – One piece instrument
Article number Description
Report
1806-2035
PHN Target Device
TI2078/09
62-51217
Drill Guide
TI2078/09
1806-0170w
Hammer
TI2078/09
12-30180
Bi-polar Forceps, Bayonet
TI2078/09
-
PPSU Templates
TI1737/07
-
VariAx Trials
Ti2347/09 and Ti2346/09
Group II
Instruments for bone cutting, piercing or scraping Group III
Cannulated instruments
Group II – Instruments for bone cutting, piercing or scraping
Article number Description
Report
Group IV
702807
Tap dia 6.5 × 180mm
TI2078/09
Multi-component instruments
08-01020
Nasal Rasp, fine / very fine
TI2078/09
1806-3026
Stepdrill
TI2078/09
Flexible instruments
0226-4200
Bixcut IM Reamer Head with Dovetail, dia 20
TI2078/09
Group VI
45-20001
Cannulated Screwdriver 2.0mm, AO coupling
TI1448/07
45-20006
Cannulated Tap 2.0mm, AO coupling
TI1448/07
Group V
Storage trays Group VII
Implants With these product groups Stryker Osteosynthesis is covering the division's entire portfolio and the processing instructions can be presented in a generic form. Specific instructions for each product would not give the health care professional or sterilization facility any additional benefit. The representative products listed below were used in the validation.
Group III – Cannulated Instruments
Article number Description
Report
12-04239
Suction Tube, extra long
TI2078/09
01-19510
Mandibular Channel Retractor, Bremerich
TI2078/09
1806-3065
5mm, Spreading Screwdriver
TI2078/09
1320-0190
Gamma3 Stepdrill
TI2078/09
45-20001
Cannulated Screwdriver 2.0mm, AO coupling
TI1448/07
45-20006
Cannulated Tap 2.0mm, AO coupling
TI1448/07
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Appendix 2
Group IV – Multi-component instruments
Article number Description
Report
4920-1-010
Hoffmann II Rod to Rod Coupling
TI2078/09
4960-3-000
Hoffmann II Micro Lengthener Assembly
TI2078/09
702428
Elastosil Handle, small
TI2078/09, BML 08037
703566
AxSOS Tibia Targeting Arm
TI2078/09
4936-9-010
Tenxor Wire Tensioner
TI2078/09, BML 08037
0730400
Reposition Clamp
TI2078/09
62-20125
Plate Cutting Pliers
TI2078/09
5057-6-300
Pin Cutter
TI2078/09
62-20295
Screwdriver Handle, revolving, rigid
TI2078/09
702628
Elastosil T-Handle
TI2078/09
6514-7-102
Luhr-Fritzemeier
TI1728/07
0193-3600
Large Locking Forceps
BSL Bioservice 084292 + 084293
704050
Omega3 TSP Aiming Block
BML08-041
702778
AxSOS Handle
BML08-216
13-19410
Scissors straight
TI2451/10
62-00082/ 62-00081
Activation Rod (MID II)
TI2262
62-50101
Quick Drive Mini
TI2076/09
1320-5340/ -50, -60
Gamma3 DTS Adjusting Device
240608CB9
69-1022074
T2 Guide Wire Pusher
SMP Report no 00810011401
SK1-913-07
One-Piece Target Sleeve
SMP Report no 04808011403
SK1-08-776
T2 Guide Wire Ruler
SMP Report no 16308012611
SK1-08-989
Gamma3 U-Blade Extractor
SMP Report no 18108012612
Group V – Flexible Instruments
Article number Description
Report
1150-0300
TI2078/09
Reamer Shaft
0227-8510
Flexible Reamer Shaft, 8mm
TI2078/09
1806-0073
Teflon Tube
TI2078/09
1320-0233
Gamma3 Flexible Screwdriver
MDS Test Report 081727-10-A and B, Test Report 230408CG1
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Appendix 2 Group VI – Storage trays
Article number Description
Report
29-32400
Asnis Micro Tray
TI2078/09
29-13009
VariAx Hand level 4 container
TI2078/09
901585, 901587, Asnis III, 6.5 & 8.0 trays 901584, 901588
TI2078/09
902913
AxSOS Targeting 5.0mm instrument tray
TI2078/09
-
Inlays VariAx Hand
SMP report no. 09606011411
-
Screw Racks
TI1504/07
-
Inlays VariAx Foot
TI1504/07
29-30015
Silicone Mat
TI2042/09
902855
MMT VariAx Elbow EPS
150408CG1
902845
MMT AxSOS Targeting Proximal Lateral Tibia
210307CG3
902846
MMT AxSOS Targeting 4.0mm Instruments
210307CG3
1768F955
Asnis Micro Screw Rack
TI1424/07
1320-9550/ -60
Gamma3 DTS Tray R1.5/ R2.0
240608CB7
Group VII – Implants
Article number Description
Report
1732-1248 (S)
S2 Femoral Nail A/R, dia 12 × 480mm
TI2381/09
1832-3830 (S)
T2 Proximal Humerus Nail, long, dia 8 × 300mm
TI2381/09
1859-5120 (S)
Condyle Screw, dia 5 × 120mm
TI2381/09
436008
AxSOS Distal Radius Plate 3.0
TI2381/09
SHBIP9TS
Numelock II 4.5 Distal Medial Humerus Plate
TI2381/09
326780
Asnis III 8.0 / 180mm, St
TI2381/09
40-20230
Asnis Micro 2.0mm Cannulated Screw, length 30mm
TI2381/09
5425393
VariAx Distal Radius Universal Volar DR Plate, wide, extra long
TI2381/09
92-15904
Screw 1.5 × 4mm, self drilling (Neuro)
TI2381/09
50-20362
MMF Screw, self drilling 2.0 × 12mm
TI2381/09
55-10580
Locking Osteotomy Plate
TI2381/09
55-28934
Full Secondary Recon Plate
TI2381/09
55-28100
Condyle Prosthesis
TI2381/09
92-00647
Pre-bent Mesh for 1.7 / 1.9mm Screws
TI2381/09
629164, 629088
VariAx Elbow Plates
BML09-424
62-00435, 62-00420
MID Distractor
TI2262
340638
Cortex Screw S.T: 4.5 × 38mm
BML08-144
This list will be updated periodically. 15
Appendix 3 Guidelines to check proper functionality of the medical devices The following guidelines should be applied to all Stryker Osteosynthesis instruments which are labeled for multiple use. All functional checks and inspections described below also cover the interfaces with other instruments or components. The failure modes below may be caused by end of life of the product, improper use or improper maintenance.
Functional check for multiple use Drill Bits
Stryker Osteosynthesis does not usually define the maximum number of uses for re-usable medical devices. The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device. However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date.
Coupling end eroded
Description and Function: Multiple use drill bits, cannulated drill bits, burrs, taps, core drills Typical Failure Modes: • Defective coupling end (eroded) • Blunt and dull cutting flutes • Tips, helix coil, bent Preventive Maintenance: Such instruments are recommended as single patient use. Regular functional check and visual inspection. In case of failure, the instrument must be replaced and not be used.
Blunt / dull tip Please check at tip of drill (see mark)
Dents on cutting flutes
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Appendix 3 Drill Bit: Overview
Drill bit: twisted
Drill bit: blunt / dull cutting flutes
Drill bit: helix coil - the cutting flutes change direction
Drill bit: blunt / dull cutting flutes and helix
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Appendix 3 Functional Check for Reamers
Description and Function: Intramedullery reamer, reamer heads, reamer shaft
Reamer shaft: deformed
Typical Failure Modes: • Defective coupling end • Blunt and dull cutting flutes • Tips, helix coil of reamer shaft deformed Preventive Maintenance: Regular functional check and visual inspection. In case of failure, the instrument must be replaced and not be used.
Reamer bit: blunt / dull cutting flutes
Chunking in cutting flutes
Blunt / dull cutting flutes and tip
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Appendix 3 Functional Check for Screwdriver Blades
Description and Function: Screwdrivers with drive connections of various designs with or without selfretaining function.
Hexagon drive connection: fractured
Typical Failure Modes: • Deformation of the blade (twisted) • Deformation of the blade (rounded) • Breakage of the blade´s self-retaining mechanism without function • Corresponding drive connection of screw head is rounded or worn.
Hexagon drive connection: deformed
Preventive Maintenance: Use an appropriate instrument spray for the mechanism of the self-retaining screwdrivers. Regular functional check and visual inspection. Replace and do not use in case of failure. Regular functional check of corresponding items (screwdrivers - screws).
Hexagon drive connection: rounded
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Appendix 3
Hexagon drive connection: deformed
Hexagon drive connection: deformed
Hexagon drive Gamma Lag Screwdriver for U-Blade: deformed and broken off pegs connection
Gamma Lag Screwdriver: deformed/ broken off pegs
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