Transcription
Reprocessing Instructions forReusable Surgical InstrumentsEnglish
Table of contentsDESCRIPTION .1MATERIALS .1INTENDED PURPOSE .2INDICATIONS, CONTRAINDICATIONS AND PATIENT POPULATION .2CAUTIONS .3LIMITATIONS ON REPROCESSING .4CLEANING, INSPECTION, PACKAGING .5A. Pre-treatment at the Point of Use . 5B. Loading and Transportation . 5C. Disassembly . 5D. Preparation of Cleaning (For All cleaning methods) . 5E. Cleaning- Manual Method with Ultrasonic . 6F. Cleaning -Automated /Mechanical Method . 7G. Inspection, Functional Check . 7H. Packaging . 9STERILIZATION .10In the United States . 10Outside United States. 10STORAGE AND SHELF LIFE .11VALIDATION INFORMATION .11For Manual Cleaning/Automated Cleaning Validation . 11For Moist Heat Sterilization Validation . 11DISPOSAL INFORMATION .12ADVERSE INCIDENT REPORTING .12INFORMATION .13REFERENCES 14SYMBOLS GLOSSARY .15
DESCRIPTIONReprocessing instructions is intended for health care professionals. This material is intendedto assist hospital personnel in safe handling, and effective reprocessing reusable surgicalinstruments, instrument trays and cases supplied Non-Sterile by United OrthopedicCorporation (United). All hip, knee, trauma, and extremity of United reusable medicalinstruments must be cleaning, inspection, packing and sterilization prior to use.United has validated the processes provided in reprocessing instructions to be capable ofbeing effective. Equipment, operators, cleaning agents and procedures all contribute to theefficacy of the processing. The healthcare facility should ensure that the selectedreprocessing steps are safe and effective. Alternative methods of reprocessing outside thescope of these instructions may be suitable for reprocessing; however, those must bevalidated by the end user. In the event of conflicting national cleaning and sterilizationrequirements, these shall prevail over United recommendations.MATERIALSAluminum alloyCobalt/Chromium alloysStainless steelsTitaniumTitanium alloysTitanium Nitride coatingsPolymersSilicone rubber1
INTENDED PURPOSEUnited surgical instruments are designed for United implant systems and intended to beused by orthopedic surgeons to facilitate the implantation or explanation of specificimplants described in the product-specific surgical technique.The use of the identified instrumentation in accordance with its applicable surgicaltechnique is essential to achieve the intended placement of the implant as described in therelevant surgical technique. The use of incompatible instruments (e.g. from another system)may lead to unpredictable short- and long- term clinical consequences. The incorrect use ofthe subject instrumentation may also lead to short- and long term clinical consequences.Instrument trays and cases are intended to facilitate the organization, identification,storage, transportation, cleaning, and sterilization reprocessing of instruments.General surgical instruments are available to facilitate surgical procedures to implantsystem.INDICATIONS, CONTRAINDICATIONS AND PATIENT POPULATIONFor information relating to indications, contraindications, patient population and clinicalbenefits can be found in the specific implant instructions for use.2
CAUTIONS1. Federal law restricts this device to sale by or on the order of a licensed healthcarepractitioner.Following symbol:2. Reprocessing instructions apply to: Reusable surgical instruments supplied Non-Sterile by United3.4.5.6. Instruments intended for reprocessing in a health care facility settingDo not apply to single-use devices.Personal Protective Equipment (PPE) should be worn when handling or working withcontaminated or potentially contaminated devices. PPE includes: gown, mask, gogglesor face shield and shoe covers.Do not place heavy instruments on top of delicate devices.Do not use metal brush, scouring pads, abrasive cleaner during manual cleaningprocedures. These materials will damage the surface and finish of instruments. Softbristled, nylon brushes and pipe cleaner brushes should be used.7. Cleaning agents with a pH 7 9, low foaming surfactants, nonabrasive, free-rinsing,biodegradable and environmentally friendly, provides for rapid soil dispersion orsuspension should be used during cleaning to ensure that instruments are visible in thecleaning solution. Cleaning agents must be easily and completely rinsed from devicesurfaces to prevent accumulation of detergent residue.8. Manual scrubbing with brushes should always be performed with the instrument belowthe surface of the cleaning solution to prevent formation of aerosols and splashingwhich may spread contaminants.9. Do not use saline and cleaning/disinfection agents containing aldehyde, mercury, activechlorine, bromine, or iodide. These are corrosive and should not be used.10. Do not place or soak instruments in Ringers Solution.11. Do not use oil-lubricants. Because these may: 1) coat microorganisms; 2) prevent directcontact of the surface with steam; and 3) be difficult to remove.12. Do not apply that the devices are not manufactured and/or distributed by United. Onlydevices manufactured and/or distributed by United should be placed in Unitedinstrument trays and cases. These validated reprocessing instructions are not applicable3
that the devices are not manufactured and/or distributed by United.13. Do not use descaling agents that include morpholine in steam sterilizers. These agentsleave residue which may damage polymer instruments over time.14. Do not stack cases or trays during sterilization. Because it may limit steam penetrationand prevent effective sterilization of the instruments.15. Under certain classifications of risk, the World Health Organization (WHO), or localregulatory authorities recommend special Creutzfeldt-Jakob disease (CJD/TSE)inactivation processing procedures. Consult WHO and local regulations for furtherinformation.16. Do not be equal to/or greater than 140 C/284 F in washer/sterilizers. The mostpolymers will occur severe surface damage.17. Flash (immediate-use) steam sterilization shall be used as an emergency procedure.Instruments shall be cleaned and disassembled without sterilization wrap or rigidcontainer.18. May have sharp edges. Handle with care.19. Do not use concentrated alcohol, and certain liquid chemical sterilants (LCSs)/high-leveldisinfectants (HLDs) (e.g. ortho-phthalaldehyde (OPA)). These can denature proteins.20. Contain and transport in a labeled, closed, puncture proof device per OSHArequirements.21. To make sure the procedure properly of cleaning the device, if failure to clean may resultin insufficient sterilization.LIMITATIONS ON REPROCESSINGThe useful life of these devices depends on many factors including the method and durationof each use, and the handling between uses. Careful inspection and functional test of thedevice before use is the best method of determining the end of serviceable life of themedical device. Evidence of damage and wear on a device may include but is not limited tocorrosion (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, excessively worn and not repaired or reconditionedby United authorized personnel devices should not be used. If there is a need to returninstruments to your sales or United, the devices must be cleaned, packaged and sterilizedbefore returning.4
CLEANING, INSPECTION, PACKAGING Remove contamination: As soon as possible after use, removeexcessive soiling with a disposable wipe, rinse and flush lumeneddevices with sterile or deionized water to prevent the drying ofsoil and/or debris to the inside. Ensure that no instruments or pieces of instruments are left inthe surgical site prior to closure, as they may not be detectableusing imaging techniques such as X-ray or MRI and patient injurymay result. Process instruments as soon as is reasonably possible after use.It is recommended not to delay cleaning for more than 2 hours. If transfer to the reprocessing area likely to be delayed, considercovering the medical devices with a damp cloth or store themedical devices in closed boxes to avoid drying of soil. If desired, place the instruments in its respective position withinthe instrument tray. The position of the instrument is labeled inits intended position within the tray.C. Disassembly Disassembly multi-piece or complex instruments referred totheir cleaning instructions. Care should be executed to avoidlosing small screws and components. The cleaning instructionsare available from your local sales representative or United.D. Preparation ofCleaning (ForAll cleaningmethods) Prepare a cleaning solution (Enzymatic/Detergent) provenefficacy and neutral pH 7 9 in accordance to the manufacturer’sinstructions provided information concerning specific materials,temperature, water quality, time, cleaning method. Tap water could be referred to the utility water of AAMI TIR34:Hardness 150ppm, Conductivity 500μS/cm, Chlorides 250ppm, Total organic carbon 1mg/mL. Used primarily forflushing, washing and rinsing. The cold tap water is at less 40 C.The warm tap water is at 30 44 C. Deionized(DI) water (ultra-filter (UF), reverse osmosis (RO), orequivalent) shall be referred to the critical water of AAMITIR34[10], Hardness 1ppm, Conductivity 10μS/cm, Chlorides 1ppm, Bacteria 10CFU/mL, Endotoxin 10CFU/mL, TotalA. Pre-treatmentat the Point ofUseB. Loading andTransportation5
organic carbon 1mg/mL. Used primarily for final rinses andsteam generation. The warm deionized water is at 30 44 C. TheHot deionized water is at more than 44 C.E. CleaningManualMethod withUltrasonic Equipment: various sized soft-bristled brushes, lint-free clothssyringes, pipettes and/or water jet, ultrasonic cleaner, cleaningbath or vessel large enough to allow complete immersion of theinstruments.1)Soak soiled instruments and prevent air bubbles to ensure thatall surfaces have contact with an enzyme solution for a minimumrecommended time specified by the enzymatic cleaning solutionmanufacturer or 20 minutes, whichever is longer.2)Brush the instruments with cleaned soft-bristled, nylon brush toclean and remove all traces of blood and debris. Particularattention must be given to crevices, lumens, mated surfaces,connectors and other hard-to-clean areas. Lumens should becleaned with a long, narrow, soft-bristled brush (i.e. pipe cleanerbrush). For flexible shafts and springs, flex and relax theinstrument under the cleaning solution while brushing.3)Flush each difficult brush area thoroughly and aggressively incold tap water for a minimum of 30 seconds. Use of a syringe orwater jet will improve flushing of difficult to reach areas andclosely mated surfaces. Repeat step 2 3 until all visible soil hasbeen removed.4)Rinse the instruments in cold top water for a minimum of 3minutes.5)Ultrasonic cleaning: Fully soak the opened instruments andprevent air bubbles to ensure that all surfaces have contact withan enzyme cleaning solution for 30 minutes at 45-50 kHz.6)Rinse the instruments in cold tap water for a minimum of 3minute. Repeat steps 2–6, until no visible debris, soil, enzymecleaning solution remains on device.7)Final rinse the instruments in warm deionized water for aminimum of 3 minutes to irrigate the challenging designfeatures.8)Dry the instruments after final rinse with a clean towel or cleancompressed air until visibly dry.6
F. Cleaning Automated/MechanicalMethodG. Inspection,FunctionalCheck1)Cleaning-Manual method with Ultrasonic step 1-6 should occurprior to this step. Mechanical washer with approved efficacy(e.g. Verified by ISO 15883) should be used.2)Load the opened instruments in the washer such can drain (forexample, hinges should be open and cannulations and holes candrain).3)Process parameters follow "INSTRUMENT" cycle parametersvalidated by mechanical washer manufacturer and a pH neutralcleaning agent intended for use in automated cleaning using theMINIMUM cycle parameter set points below:CycleMinimumTimeTemperatureLiquidPre-wash2 minutes 40 CTap waterWash I5 minutes30 44 CEnzymatic solutionWash II5 minutes66 CNeutral pH DetergentsolutionRinse10 minutes 44 CDeionized waterDrying30 minutes100 CNone Visual inspect all instruments, instrument trays, cases afterprocessing prior to sterilization for: (Generally un-magnifiedvisual inspection under good light conditions.)Cleanliness: Ensure the complete removal of soil fromsurfaces, tubes and holes, moveable parts. If soil is stillpresent, re-clean the instrument. Particular attentionshould be paid to: Soil “traps” such as mating surfaces,hinges, shafts of flexible reamers; recessed features (holes,cannulations) ; features where soil may be pressed intocontact with the device, e.g. drill flutes adjacent to thecutting tip, sides of teeth on broaches and rasps.7
Note: If contamination is noted repeat the cleaningprocess.Completeness, damage and/or excessive wear: Visuallyinspect for no damage including but not limited to,malfunction, burrs, wear, tear, corrosion (rust, pitting),discoloration, creaked seals, excessive scratches andflaking.Note: If damage or wear is noted that may compromise thefunction of the instrument, contact your sales or United. Functional check should be performed. Improperly functioningdevices, devices with unrecognizable markings, missing orremoved (buffed off) part numbers, damaged and worn devicesshould not be used. The disassembled instruments should bereassembled to check the function.Check ItemsSuitable for UseNot Suitable for UseCan’t be reassembled suchas missing parts or can’t besmooth moved.AssemblableReassembled successfully.HingedinstrumentsSmooth operation throughout Can’t be operated asthe intended range of motion. intended.LockingmechanismsCan be locked to the positionUnable to lock.as intended and not loosening.Cutting featuresReamer/DrillTrialsEdges should be continuouswithout burrs.Edge distortion/large nicks.Smooth and free of cracks anddeep nicks. (Minor crack don’t Cracks and deep nicks.affect the smooth operation isacceptable.)8
Loose burrs or large nicks.HammeringsurfacesFlexible featuresInstrumenttray/caseWithout burrs and large nicks.Flex and relax to inspectflexible feature like shafts,springs for any damage andmajor deformationMajor deformation or can’toperate smoothly.Inspect for burrs and lockingfrom damage the wrap.(Minor burr is acceptable.)Burrs or locking mechanismloosening which maydamage the wrap.UDI Information Use DataMatrix barcodescanners to scan the UDIcarrier to check is readable.Can’t read UDI carrier.Note:If any status above is noted, do not use the instrument andcontact your sales or United. The instruments can be reused only if itis reconditioned by United.H. Packaging Use instrument cases to contain cleaned, checked, dryinginstruments that are provided in the instrument sets. For a sterilization wrap: United cases should be double wrappedaccording to AAMI/CSR technique. The packaging for terminallysterilized re-usable instruments should meet the followingrequirements:ISO 11607-1, CE Mark or FDA clearance,suitable for steam sterilization. In the United States (US), onlyuse an FDA-cleared Sterilization wrap. For a rigid steam sterilization container system: AesculapSterilContainer System -JN-400 JN-446 included with base ventsuse as packaging for the instrument sets. No more than one casecan be placed directly into a rigid steam sterilization container. The total weight of a wrapped instrument case should notexceed 11.4kg/25lbs.9
STERILIZATIONUsing ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurancein Health Care is recommended to be steam sterilized by the health care facility using theprocess parameters below, which has been validated by United under laboratory conditionsto provide a 10-6 sterility assurance level (SAL). A verified, properly maintained andcalibrated steam sterilizer is recommended. The process parameters of sterilization shouldbe followed explicitly. It is the responsibility of the medical facility to ensure thatreprocessing is performed using the appropriate equipment and materials, and thatpersonnel in the reprocessing facility have been adequately trained. In the United StatesCycle TypePulseNumberExposureTemperatureMinimumExposure timeMinimumDrying timesDynamic-Air-Removal(Pre-vacuum)4132 (270 )4 minutes30 re timeMinimumDrying times132 135 (270 275 )4 minutesOutside United StatesCycle oval(Pre-vacuum)For CJD/TSE contamination14134 1(273 )130 minutes18 minutes1Under certain classifications of risk, the World Health Organization (WHO), or local regulatory authoritiesrecommend special Creutzfeldt-Jakob disease (CJD/TSE) inactivation processing procedures. Consult WHOand local regulations for further information.10
STORAGE AND SHELF LIFEAfter sterilization, re-usable instruments should be stored the in the sterilization wrap in adry and dust-free place. The shelf life is depending on the sterile barrier employed, storagemanner, environmental conditions and handling. A maximum shelf life for sterilized reusable instruments before use should be defined by each health care facility. Instrumentsmust be examined for possible damage before use. Protective caps or other protectiveelements must be removed before cleaning.VALIDATION INFORMATION For Manual Cleaning/Automated Cleaning Validation:The reusable devices are exposed to the artificial test soil which is a mixture of Edinburgh testsoil and bone meal to simulate the clinical soil, and be dried for 2 hours prior to clean. Aftermanual cleaning/automated cleaning, visually inspect for any sign of remaining soil and testresidual protein and total organic carbon (TOC) to an acceptable level.Following standards: AAMI TIR12, AAMI TIR30, AAMI TIR34, ANSI/AAMI ST79,ANSI/AAMI ST81, ISO 17664 and "Reprocessing Medical Devices in Health CareSettings: Validation Methods and Labeling Guidance for Food and DrugAdministration Staff".Detergents: 3M Rapid Multi-Enzyme Cleaner(70503), Prolystica 2X ConcentrateEnzymatic Presoak And Cleaner (1C33), Prolystica 2X Concentrate NeutralDetergent(1C32)Automated washer – Miele PG 8535 For Moist Heat Sterilization Validation:The reusable devices in a maximum weight of loaded tray are placed biological indicators (BI)inoculated with more than one million (106) resistant spores (Geobacillusstearothermophilus) in the most challenging locations. The tray is packed with a sterilizationwrap or rigid steam sterilization container system. The packed tray loaded in an emptychamber of steam sterilizer is validated a 10-6 sterility assurance level (SAL) by overkillmethod that half-cycle sterilization cycle result in total kill of all BIs demonstrating in11
accordance with ISO 17665-1 Annex D. Recommended dry time is validated by demonstratingthat pre-sterilization and post sterilization wrap/filter weight is no exceed 3 percent weightgain and no visible moisture on or within the sterilized packing, container, tray, instruments.Following standards: AAMI TIR12, ANSI/AAMI ST77, ANSI/AAMI ST79, ANSI/AAMI ST81, ISO17664, BS EN ISO 17665-1, ISO/TS 17665-2, AAMI/ISO TIR17665-3 and "ReprocessingMedical Devices in Health Care Settings: Validation Methods and Labeling Guidance forFood and Drug Administration Staff". Sterilization wrap: Kimguard KC600 One-Step wrapRigid steam sterilization container system: Aesculap SterilContainer Systems JN446(Bottom), JK486(Lid), MD344(Filter).Steam Sterilizer: AMSCO Eagle 3023-S Vacamatic Prevacuum Steam Sterilizer.DISPOSAL INFORMATIONAfter use, an instrument is a potential biohazard, since it may be contaminated with bloodor other body fluids, bone or other tissue. Handle and dispose of this product in accordancewith accepted medical practice and with applicable local, state and national laws andregulations. In the event of an alleged product failure it is important to have theinstrumentation returned to United for investigation.Any sharp objects should be disposed of immediately after use into a sharps containerconforming to national laws. The sharp object must not be bent, broken or resheathed priorto disposal.ADVERSE INCIDENT REPORTINGFor EU users, if any serious incident that has occurred in relation to the device should bereported to the manufacturer and the competent authority of the Member State in whichthe user and/or patient is established.12
INFORMATIONFor further information, please contactmdi Europa GmbHLangenhagener Straße 7130855 Langenhagen, GermanyTEL: 49-511-3908 9530United Orthopedic CorporationNo. 57, Park Ave 2, Science Park,Hsinchu City, 30075, Taiwan.TEL: 886-3-5773351FAX: 49-511-3908 9539FAX: om/contact/#form13
REFERENCES1. AAMI TIR12: Designing, testing, and labeling medical devices intended for processingby health care facilities: A guide for device manufacturers.2. AAMI TIR30: A compendium of processes, materials, test methods, and acceptancecriteria for cleaning reusable medical devices.3. AAMI TIR34: Water for the reprocessing of medical devices4. ANSI/AAMI ST77: Containment devices for reusable medical device sterilization.5. ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurancein health care facilities.6. ANSI/AAMI ST81: Sterilization of medical devices—Information to be provided by themanufacturer for the processing of resterilizable medical devices.7. ASTM F565: Standard Practice for Care and Handling of Orthopedic Implants andInstruments.8. ISO 11607-1: Packaging for terminally sterilized re-usable instruments.9. ISO 15223-1: Medical devices- Symbols to be used with medical device labels,labeling and information to be supplied - Part 1: General requirements.10. ISO 17664: Sterilization of re-usable instruments -Information to be provided by themanufacturer for the processing of resterilizable re-usable instruments.11. ISO 17665-1: Sterilization of health care products - Moist heat - Part 1: Requirementsfor the development, validation and routine control of a sterilization process formedical devices.12. ISO 17665-2: Sterilization of health care products - Moist heat - Part 2: Guidance onthe application of ISO 17665-1.13. ISO 17665-3: Sterilization of health care products - Moist heat - Part 3: Guidance onthe designation of a medical device to a product family and processing category forsteam sterilization.14. Reprocessing Medical Devices in Health Care Settings: Validation Methods andLabeling Guidance for Food and Drug Administration Staff, 2015.15. European Commission, Council Directive 93/42/EEC.16. Regulation (EU) 2017/745 of the European Parliament and of the Council.17. ISO 16061: Instrumentation for use in association with non-active surgical implantsGeneral Requirements.14
SYMBOLS GLOSSARYSymbol(s)Title of symbolDescription of symbolMedical DeviceIndicates the item is a medical device.On the implant card, this symbol is used toindicate the device name (MDCG 2019-8 v2Guidance document Implant Card relating to theapplication of Article 18 Regulation (EU)2017/745 of the European Parliament and of theCouncil of 5 April 2017 on medical devices).ISO 15223-1 / 5.7.7Indicate the manufacturer’s catalogue number.ISO 15223-1 / 5.1.6Indicate the manufacturer’s batch code.ISO 15223-1 / 5.1.5ManufacturerIndicate the medical device manufacturer, asdefined in EU Directives 93/42/EEC.ISO 15223-1 / 5.1.1CautionIndicate the need for the user to consult theinstructions for use for important cautionaryinformation such as warnings and precautionsthat cannot, for a variety of reasons, bepresented on the medical device itself.ISO 15223-1 / 5.4.4Authorizedrepresentative in theEuropean CommunityIndicate the authorized representative in theEuropean Community.ISO 15223-1 / 5.1.2Prescription Only.Caution: Federal law restricts this device to saleby or on the order of a licensed healthcarepractitioner.1. 21 CFR 801.15(c)(1)(i)F2. 21 CFR 801.109Indicate the device is supplied non-sterile.NA. United internalsymbology.Catalogue numberBatch codeRx onlyNon-SterileCE MarkingCE MarkingQTYQuantityUnique DeviceIdentifier (UDI)ImporterIndicate a presumption of conformity with therelevant EU Directives/REGULATION.Refer to label for CE mark and identificationnumber of the notified body responsible forconformity assessment (if applicable).Indicate a presumption of conformity with therelevant EU Directives/REGULATION. Refer tolabel for CE mark and identification number ofthe notified body responsible for conformityassessment (if applicable).Standard / Ref. No.1.Directive 93/42/EEC2.Regulation (EU) 2017/7451.Directive 93/42/EEC2.Regulation (EU) 2017/745Indicate the quantity in a package of the medicaldevice.NA. United internalsymbology.Indicates a carrier that contains Unique DeviceIdentifier information.ISO 15223-1 / 5.7.10Indicates the entity importing the medical deviceinto the locale.ISO 15223-1 / 5.1.815
2797 2021 United Orthopedic Corporation.UOC-UM-UN-00029 Rev.3 DEC. 2021
4) Rinse the instruments in cold top water for a minimum of 3 minutes. 5) Ultrasonic cleaning: Fully soak the opened instruments and prevent air bubbles to ensure that all surfaces have contact with an enzyme cleaning solution for 30 minutes at 45-50 kHz. 6) Rinse the instruments in cold tap water for a minimum of 3 minute.
