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1、HOSPITAL STERILIZATION OF 3D PRINTED DEVICESName:R.EvelandK.AntlogaA.MeyerL.TuscanoAffiliation:STERIS(Mentor,OH United States)Outline Introduction to 3D printing in Healthcare Path of a 3D printed device from Patient Scan to Operating Theater Sterilization of 3D Printed Devices Overview of Hospital
2、3D Printing Process 3D Printed Materials after VH2O2 sterilization Introduction to 3D Printing in Healthcare 3D printing/additive manufacturing(AM)is the process of making three dimensional solid objects from a digital file Applications in patient and healthcare professional education,training,pre-s
3、urgical and surgical use,and as a personalized implant Better patient experience:less pain,shorter hospital stays and quicker recoveries In healthcare,3D printing is not new GEAdditive Arcamhas made over 100,000 3D printed hips since 2007*What is new is the Point-of-Care,in-hospital printing of pati
4、ent-specific devices Is MDR appropriate for hospital produced devices?Chapter II,Article 5:regulation shall not apply to devices manufactured and used in a hospital so long as certain conditions are met*https:/ Deposition Modeling(FDM)A strand of material is heated and deposited in layers to create
5、a 3D printed objectStereo-Lithography Apparatus(SLA)A curable photopolymer(typically a liquid resin)is hardened by applying focused light or UV lightSelective Laser Sintering(SLS)A laser is used to fuse a thermoplastic powder to build partsDirect Metal Laser SinteringCreates objects by fusing a meta
6、l powder with a laserMaterial Jetting(MJ)Droplets of material are selectively deposited and cured on a build plate Electron Beam Melting(EBM)An electron beam is used to fuse metal powder together to build parts3D Printing TechniquesSplint/ProstheticsPatient specific,quick productionSurgical GuidePat
7、ient specific,surgical useHearing AidComplex design,quick productionTraining/Patient Educationhttps:/www.3ders.org/articles/20160304-london-doctor-uses-3d-printed-model-to-successfully-remove-prostate-tumor.htmlWhy 3D Print in Healthcare?https:/resources.asme.org/hubfs/AM%20Summit/Medical%20AM3DP%20
8、Year%20In%20Review%2019-20.pdfExpected Growth in 3D Device UseCommunity SurveyPath of a 3D/AM Device from Patient Scan to Operating TheaterObtain Medical Imaging DataSegmentationPrintingSterilizationSurgical UseCleaningRegulatory Challenge:Lack of standards or guidance for in-hospital 3D printing in
9、 hospital Path of a 3D/AM Device from Patient Scan to Operating Theater Radiology and image acquisition processes Computed Tomography(CT)Magnetic Resonance Imaging(MRI)Ultrasound(US)Segmentation software manufacturer is responsible for providing validated,cleared software with clear instructions for
10、 use3D lab performs segmentation and conversion of patient data to 3D printer readable filesClinicians review segmentation data and generate surgical plan Obtain Medical Imaging DataSegmentationPath of a 3D/AM Device from Patient Scan to Operating Theater 3D lab prints device with an approved printe
11、r and material Radiology and hospital 3D print lab are responsible for following the printer manufacturers instructions for use(including the post-processing steps),the process validation and quality control proceduresWash,clean,dry and package for sterilizationSterilize as directed for the material
12、CleaningPrintingSterilizationSurgical UseA Quality Management System is Needed!Sterilization of 3D Printed Devices Industrial Sterilization Methods for 3D printed items Radiation Ethylene Oxide Vaporized Hydrogen Peroxide Hospital Sterilization Methods for 3D printed items Steam Ethylene Oxide Vapor
13、ized Hydrogen PeroxideSterilization of 3D Printed Devices A 3D print sterilization process should demonstrate Sterile efficacy Biocompatibility(pre-and post-sterilization)ISO 10993 series Level of testing is based on device application Material compatibility Material properties Geometric stability3D
14、 Printing Special Interest Group(rsna.org)Sterilization of 3D Printed Devices Print in a clean,controlled environment 3D devices should be printed in a way that allows for sterilization Popescu et al noted that FDM printed ABS showed formation of air gaps within layers US FDA and Australian TGA have
15、 identified voids or bubbles within a 3D printed material as a potential concern for sterilization Some processes may be more likely to create voids in printing Popescu D_Effect Disinfect Absorption Med Decontam of 3D ABS parts_Polymers_2021 13 42492017,FDA,Technical Considerations for Additive Manu
16、factured Medical Devices Guidance for Industry and Food and Drug Administration Staff“https:/www.tga.gov.au/resources/resource/guidance/3-d-printing-additive-manufacturing-medical-devicesSterilization of 3D Printed Devices Just as with traditional surgical guides,surgeons can damage surgical guides
17、during use with drills or sagittal saws Potential for plastic debris and potential for contamination from voids that are opened with the damage As with traditional medical device manufacturing,part production under a QMS with a fully validated process mitigates the contamination riskShea G et al;A r
18、eview of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively.3D Printing in Medicine,2020 6:7.Sterilization of 3D Printed DevicesDoes the 3D printing process sterilize devices?Neches evaluated FDM printed
19、items for their intrinsic sterility FDM printer with thermal contact time of 16s at 220C Staphylococcus epidermidis and Propionibacterium acnes observed(common to skin)SLA printer:UV light cure is part of process Aguado-Maestro et al evaluated FDM printed cylinders,halting the manufacturing process
20、halfway and inoculating with E8 S.epidermis Printing was resumed and sealing of cylinders completed Cylinders sterilized with EO,steam and VH2O2 No growth in EO or steam;1-12 CFU in unsterilized and VH2O2Neches RY,Flynn KJ,Zaman L,Tung E,Pudlo N.2016.On the intrinsic sterility of 3D printing.,PeerJ,
21、4:e2661 Aguado-Maestro,M.De Frutos-Serna,A.Gonzlez-Nava et al.,Are the common sterilization methods completely effective for our in-house 3D printed biomodels and surgical guides?Injury,VOLUME 52,ISSUE 6,P1341-1345,JUNE 01,2021Sterilization of 3D Printed Devices VH2O2 is used industrially to sterili
22、ze 3D printed items Vaporized hydrogen peroxide sterilizers already in hospital are being used to sterilize 3D printed devices Multiple publications from around the world Studies do not evaluate all aspects of sterilization verification(efficacy,biocompatibility and material compatibility)The hospit
23、al sterilizers current cycles do not have claims for 3D printed devicesVH2O2 Sterilization of 3D Printed DevicesAuthor(year)ResultTrk(2020)Disinfection and sterilization effect on dimensional changes and mechanical properties of 3D printed surgical guides The guides were not changed by the VH2O2 ste
24、rilization or steam sterilization at 121 C.Shaheen(2018)Evaluated after steam and VH2O2 sterilization for material changes,specifically volume of the test article Steam was noted to have an effect,VH2O2 did notShea(2020)Clinically used devices infection rate for VH2O2 sterilized 3D-printed models an
25、d guideInfection rate(7%,8/114)not different traditional surgical methods.Of the 114 cases,there were 59 anatomical models&55 surgical guides Toro(2021)3D printed parts maintained dimensional stability after VH2O2 sterilizationTrk,G,et al;Effects of disinfection and sterilization on the dimensional
26、changes and mechanical properties of 3D printed surgical guides for implant therapy pilot study.,BMC Oral Health(2020)20:19.Shaheen E,et al;Evaluation of dimensional changes of 3d printed models after sterilization:a pilot study.Open Dent J 2018;12:729.Shea G;et al,A review of the manufacturing proc
27、ess and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively,3D printing in medicine,(2020 Mar 30)Vol.6,No.1,pp.7.Toro M;et al,Does vaporized hydrogen peroxide sterilization affect the geometrical properties of anatomic models and guide
28、s 3D printed from computed tomography images?.,3D printing in medicine,(2021 Sep 14)Vol.7,No.1,pp.29.ToroTorokSheaSterilizer Indications for UseThe Specialty Cycle Can Sterilize:Patient-specific surgical guides(e.g.osteotomy,shoulder,hip,knee,spine)or anatomical models fabricated via additive manufa
29、cturing(3D printing)processes and intended for single-use during operative procedures*The validation studies were conducted using a validation load consisting of pouched guide(s)/model(s)(with or without tray)for a total weight of 5 lbs(2.3 kg)3D printed material.Devices used in validation studies w
30、ere prepared in accordance with printer manufacturers instructions for use,to include printing,curing,removal of support material and cleaningK223476 at FDA 510(k)Premarket Notification website.MaterialPrinter(s)ManufacturerSpecialty CycleLumenInner Diameter(ID)x Length(L)BioMed Amber ResinForm 3B,F
31、orm 3B+,Form 3BLFormlabsF3 mm ID x 30 mm LBioMed Clear ResinForm 3B,Form 3B+,Form 3BLFormlabsD3 mm ID x 30 mm LBiocompatible Clear MED610J720Dental,J7503D,J750Digital Anatomy,J850Digital AnatomyStratasysE3 mm ID x 20 mm LBiocompatible Opaque MED615RGDJ7503D,J750Digital Anatomy,J850Digital AnatomyStr
32、atasysE3 mm ID x 20 mm LVeroGlazeMED620J720Dental,J7503DStratasysE3 mm ID x 20 mm LSurgical Guides and Anatomical ModelsAnatomical ModelsSurgical Guides*Pin guides/penetrations(A),Surgical guide slits(B)Specialty Cycle DesignCondition PhaseSterilize Phase7.5 minutesAerationDifferent aeration time ba
33、sed on materialAeration time set to ensure device is biocompatible after processingObservation:3D printed materials more difficult to aerate than reusable medical devices(aerated in 6 minutes or less)Hydrogen peroxide release from a material can be fast or slow Aeration design is based upon applying
34、 heat with air flushes and vacuum to remove H2O2 Evaporation is endothermic and will cool a material Heat can be applied to provide a driving force for vaporization Heat transfer is poor under vacuum.Further,heat transfer is limited to surfaces and the subsequent thermal transfer within an object Ex
35、pectation is that device will be at chamber temperature(50C)in about 60 minutes.At this point,hypotheses is that residual removal governed by diffusion of H2O2to outer surfaces where vaporizedUS Patent 11,541,139Specialty Cycle DesignMaterialSpecialty CycleLumen SitesSurface SitesLumen Dimension#Ste
36、rile/#Tested#Sterile/#TestedFormlabs BioMed AmberF3 mm ID x 30 mm length6/618/18Formlabs BioMed ClearD3 mm ID x 30 mm length6/618/18Stratasys MED610E3 mm ID x 20 mm length6/618/18Stratasys MED615E3 mm ID x 20 mm length6/618/18Stratasys MED620E3 mm ID x 20 mm length6/618/18SterilizationA proprietary
37、designed test article was used to evaluate for surface and lumen sterilization3D printed test articles of each material were used for evaluations in three Specialty Cycles per material 106Geobacillus stearothermophilus spores per test site(most resistant organism to VHP sterilant)Exposed to a one-pu
38、lse cycle with 59%hydrogen peroxide Incubated in growth media then evaluated for growthAll sterile results verifies sterilization efficacySpecialty Cycle Microbicidal Efficacy All materials are identified by their manufacturer(Formlabs or Stratasys)as Biocompatible In accordance with ISO 10993-1,3X
39、processed Specialty Cycle processed materials were categorized for use as a limited contact(24 hour)patient contact via mucosal membrane,breached or compromised surface,blood path(indirect),circulating blood,or tissue/bone/dentin MaterialEvaluationCytotoxicity*ISO 10993-5SensitizationISO 10993-10*In
40、tracutaneous testingISO 10993-10*Systemic ToxicityISO 10993-11*Material Mediated PyrogenicityISO 10993-11*HemocompatibilityISO 10993-4*Formlabs BioMed AmberNot cytotoxicNot sensitizingNot an irritantNot a systemic toxinNot pyrogenicHemo-compatibleFormlabs BioMed ClearStratasys MED610Stratasys MED615
41、Stratasys MED620*Testing conducted at STERIS in accordance with ISO 10993-5 standard under Good Laboratory Practice(GLP)regulations as provided in 21 CFR 58.*Testing conducted at NAMSA in accordance with the identified ISO 10993 standards.NAMSA is certified to ISO 9001:2015 and is accredited to ISO/
42、IEC 17025:2017.Specialty Cycle Biocompatibility Materials were processed for three Specialty Cycles Extracted and evaluated for hydrogen peroxide residual for 72 hours MaterialSpecialty Cyclemg H2O2/g DeviceFormlabs BioMed AmberF0.27Formlabs BioMed ClearD0.22Stratasys MED610E0.13Stratasys MED615E0.1
43、2Stratasys MED620E0.12Hydrogen Peroxide Sterilant Residue After 3x Specialty Cycle Exposure and 72-hour ExtractionSpecialty Cycle Sterilant Residue Mechanical Properties EvaluationsBased on ISO/ASTM 52910:2018(E)Additive Manufacturing Design Requirements,guidelines and recommendationsCoupons printed
44、 for each methodWorst-case chemical exposure(15x Specialty Cycle sterilant dose)Simulated Use,single Specialty Cycle exposure(select tests)Specialty Cycle Material EvaluationsTest NameASTMResultTensile StrengthD638Results showed either:No statistical difference from unexposed control Greater strengt
45、h after exposure Non-significant loss in strength Flexural StrengthD790Compressive StrengthD695Izod notched impactD256Shore HardnessD2240Mechanical Property Evaluations after Worst-Case Chemical ExposureMechanical Property Evaluations after Simulated Use ExposureTest NameASTMResultTensile StrengthD6
46、38Results showed:Simulated Use exposure is less aggressive than worst-case chemical exposureCompressive StrengthD695Shore HardnessD2240Material Compatibility Comparison of published data to VH2O2 Sterilizer processed material Stratasys MED610 Test NameSterilization Method/%Change after sterilization
47、Steam 4 min 132C%change1Gamma%change1EtO(after 1 cycle)%change1Steam 20 min 121C%change2Steam 10 min 134C%change2VH2O2 Exposure%changeTensile strength-6%19%11%-3%15%-7.5%Flexural Strength-4%42%41%0 to-7%-44 to 14%11.6%Impact,Xy,cut notch-1%-5%-7%-9.7%Dimensional Changes0 to 0.35 mm0 to 0.1 mm0 to 0.
48、3 mm-0 to 0.2 mm1.Stratasys Creating full color medical models that can be sterilized.”Technical application guide,20212.Trk,G,et al;Effects of disinfection and sterilization on the dimensional changes and mechanical properties of 3D printed surgical guides for implant therapy pilot study.,BMC Oral
49、Health(2020)20:19.Structural deformation seen with steam at 134 C.Material CompatibilityMaterial3D Scan DifferencesMeasured DifferencesFormlabs BioMed Amber 0.5 mm 0.01 mmFormlabs BioMed Clear 0.1 mm 0.01 mmStratasys MED610 0.2 mm 0.1 mmStratasys MED615 0.5 mm 0.1 mmStratasys MED620 0.5 mm 0.1 mmDim
50、ensional Analysis Pre-and Post-Sterilization Differences Dimensions evaluated pre-and post-sterilization physical measurements(calipers)Scanning with a Faro inspection arm/digital scanner Twenty to twenty-seven physical measurements were made for each modelSpecialty Cycle Dimensional AnalysisPrintin
51、gSterilizationSurgical UsePackagingCleaning Sterilizer IFU with validated process provides value to sterile processing departmentNew Path of a 3D/AM Device from Printing to Surgical UseConclusion 3D printing medical devices at the Point of Care(POC)is growing Radiological and medical community is en
52、gaged VH2O2 is a fully compatible sterilization method for select 3D printed medical devices V-PRO maX 2 Sterilizer Specialty Cycle is a validated sterilization process for specified materials,printers,and device designsAdditional Resources Journal of 3D Printing in Medicine RSNA(Radiological Societ
53、y of North America)3D Printing Special Interest Group(SIG)(https:/www.rsna.org/membership/involvement-opportunities/3d-printing-special-interest-group)US FDA (https:/www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices)American Society of Mechanical Engineers(ASME).https:/www.asme.org/topics-resources/content/additive-manufacturing YouTubeQuestionsV-PROis a trademark of STERIS its affiliates or related companies.All other product and company names referenced are trademarks of their respective owners.?