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1、SURGICAL INSTRUMENT TRACEABILITY IN STERILIZATION:LEGAL OBLIGATION vs NECESSITY?Name:David De Baets&Olivier WilliemeAffiliation:CARE-NAM(Belgium)ContextCARE-NAMA brand-new sterilization platform established respectively at 1,6 and 35 km from 3 hospitals it serves around the city of Namur in Belgium(
2、CHU UCL NAMUR(2 sites)&Clinique Saint-Luc Bouge(1 site).Scheduled for fall 2024Challenge:Place of surgical instruments or RMD(Reusable Medical Devices)and the obligation or necessity to trace them Pitfalls to avoid when engaging in this approach2CARE-NAM Today-40.000 Instruments-4000 SKU-30.000 surg
3、eries/an3WHO-World Health Organization2ndGlobal Health Challenge 2009-WHO Surgical Safety Checklist4Legislation in EURegulation(EU-European Union)2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devicesTraceability obligation concerns Class III devicesArt 27,9:Member
4、 States encourage healthcare facilities and professionals to record and retain,preferably by electronic means,the UDI(Unique Device Identifier)provided to them.No requirement to register,only advice,to be implemented by May 26,2025 5Legislation in EURegulation(EU-European Union)2017/745 of the Europ
5、ean Parliament and of the Council of 5 April 2017 on medical devicesTraceability obligation concerns Class III devicesMost of surgical instrument reusable concerns Class I,IIa&IIb6Legislation in other countries outside EUOlivier WillimeFormer VP EORNAFormer member of the International Relations Comm
6、ittee of the AORNThe question:Are there any laws or regulations on the traceability of surgical instruments in your countries?Answers:It seemed that there were no binding texts on the subject,in any case to trace each instrument individually and specifically 7Global or local traceability at a glance
7、Ren Magritte La Trahison des images-Los Angeles County Museum of Art-Muse royal dArt moderne Bruxelles-8Reasons and benefits of individual instrument tracability In legal terms(traceability):Provide proof that a DM has been sterilized by the right person,at the right time,with the right equipment,un
8、der the right conditions,Safety(Decision support):Find,at any time,a non-conforming PRODUCT in order to remove it from the circuit.Economically(Production management):To have access to data which will enable you to evaluate the sterilization activity,its cost,its weight in terms of time spent,materi
9、als,consumables and use of other resources.All this is already well established in the operating models of CSSD when the follow-up unit is a set,or even an individual instrument.9Reasons and benefits of individual instrument tracabilityWhen we decide to follow each instrument individually,the reason
10、s are more specific:Securing the re-composition of surgical and medical sets Inventory management.Availability of characteristics of each instrument.Instrument tracking throughout the process In the event of a post-operative complication,possibility to trace all the steps involved in handling the eq
11、uipment.In other words,safer patient care and optimized asset management.10Monitor indicators as partof instrument traceability for:Added-value services compared with a service provider.Our platform serves 3 hospitals,each of which owns its own instruments and sets.Present an activity report that ac
12、curately reflects the quality of the services provided,but also enables precise invoicing of the services provided for each of the 3 hospitals.Optimization of staff allocation according to activity peaks Modification of opening hours,with or without staff reinforcement Surgical instrument maintenanc
13、e monitoring11Monitor indicators as partof instrument traceability for:Number of times units washed and sterilized Number of instruments per set Number of units and instruments recomposed by sterilization staff Overall instrument handling time from pre-disinfection to distribution.Distribution of re
14、-composition workload by period of time.A finer,more realistic view of the work performed12In BelgiumCARE-NAM followsthe recommendations of SHCIn Belgium,CARE-NAM follows the Good practices in the management of reusable medical devices of the Superior Health Council(SHC 9682 02/2023)Traceability in
15、a CSS contributes to the good management of the MD and to the legal protection of the institution.Traceability is understood as the implementation of a system for tracking the MD at all stages of its life cycle and the proactive introduction of the desired processes.It is an essential part of a qual
16、ity system.It is recommended that each healthcare institution implement such a system by referring to the ISO 13485 standard.The traceability of MDs is computerised.13In Belgium,CARE-NAM follows the Good practices in the management of reusable medical devices of the Superior Health Council(SHC 9682
17、02/2023)This unique MD identification code can currently be done by datamatrix or RFID(Radio Frequency Identification).There are other,more sophisticated systems,such as RFID or AI,but they are not yet fully operational.Containers are mainly tracked,but not contents,while instruments migrate from on
18、e set to another(between 5%*to 14%*).Subterfuges are used to track individuals.*:Chambery Hospital(France)*:Metropole Savoie Hospital(France)In BelgiumCARE-NAM followsthe recommendations of SHC14Various techniques for tracing a surgical instrumentVisual reading of a reference on the instrumentOptica
19、l reading of a code on the instrumentBarcodeAffixed by userDatamatrixPrinted duringmanufacturing processby supplierBy electrochemical engravingBy laser engraverAdded after purchaseBy distributorBy laser engraverBy percussion engraverBy fusing a StructobonBy keydot bondingBy userRFID recognitionAutom
20、atic recognition:shape,weight,colorAI recognition15Visual reading of a reference on the instrument Oldest technique for completing a set&identifying each correct instrument.The surgeon and the OR nurse have defined the instruments making up the sets and expect the CSSD staff to ensure the accuracy o
21、f the composition when it is used in surgery.Success of surgery depends in part on the accuracy of set composition.Various techniques for tracing a surgical instrument+-Rapid composition when the set is simple and the instruments correctly identified on the composition lists.No traceability to the i
22、nstrument,Risk of composition errors when two instruments look alike or do not allow absolute identification16Optical reading of a barcode on the instrument This technique,used in some CSSD,involves affixing a barcode label,created by the user and sized according to the size of the available space,t
23、o the instruments making up a set.The instruments are then read by a barcode scanner when the set is put together for sterilization.Various techniques for tracing a surgical instrument+-Rapid composition when the set is simple,and the instruments correctly read by the scanner.Type of information not
24、 originalRequires a considerable amount of work to identify instruments and apply a plastic label printed.Barcode gradually fade after repeated use in LD.Label will degrade rapidly,blistering and leaving traces of glue on the instrument.The risk of infection is high.Excluded from the recommendations
25、 of the SHC.17Optical reading of a Datamatrix on the instrument printed during manufacturing process by electrochemical engraving A supplier,or even a distributor,can perform acid etching.Using an acid-base etching kit with a stencil and an electrolytic liquid solution,whereby an instrument etcher p
26、asses a low-voltage electric current through gaps in the stencil.The imprint on the stencil is transferred to the instrument.Various techniques for tracing a surgical instrument+-Instrument originally marked by the manufacturerLetters,numbers or shapes can be placed on stainless steel instruments Un
27、alterable,does not deform the material,does not create stress,does not weaken or repel the materialDifficult to realize for our old instrumentations(in-situ)Pay attention,batch number and not always UDI18Optical reading of a Datamatrix on the instrument printed during manufacturing process by laser
28、This technique has been used for several years by some instrument manufacturers,but not all,and is generally GS1 compliant.By using an appropriate scanner to read the CSSD when the sets are reassembled,By entering the data into traceability software adapted to this type of tracking,It is possible to
29、 trace each instrument correctly,while respecting the original composition.This technique is applied in the factory,and the manufacturer is responsible for the uniqueness of the coding and the quality of the printing and fusion of the metal surface.Various techniques for tracing a surgical instrumen
30、t19Optical reading of a Datamatrix on the instrument printed during manufacturing process by laserVarious techniques for tracing a surgical instrument+-Instrument originally marked by the manufacturerLetters,numbers or shapes can be placed on stainless steel instruments Technique provides high-preci
31、sion tracing and miniaturization of symbols.a high contrast of codes and symbols(better reading)a circular or cylindrical surface marking is possible.External service provider or specialized technician,Specific location for marking(machine volume and safety constraints),specific location for anti-co
32、rrosion treatment,Pay attention,batch number and not always UDI,https:/fr.gravotech.be20Optical reading of a Datamatrix code on the user-engraved instrument using a micropercussion machineMicro-percussion marking is carried out by an automatic machine and consists of applying a succession of dots to
33、 the surface of an instrument:it is based on the principle of pressing the material in.Using an electromagnetic striker,the machines tungsten carbide tip inscribes a Data Matrix barcode on the instrument,as well as alphanumeric characters.alphanumeric charactersVarious techniques for tracing a surgi
34、cal instrumentwww.machines- reading of a Datamatrix code on the user-engraved instrument using a micropercussion machineVarious techniques for tracing a surgical instrument+-A micro-percussion machine would cost between 10,000 and 25,000.Budget affordable for a hospitalLetters and numbers can be pla
35、ced on stainless steel instruments Able to engrave silver,copper,platinum,brass,aluminium,iron,stainless steel,acrylic,etc.Can be used by any properly trained CSSD staff.Easy to install.No safety measures comparable to a laser engraverImpacts the metal surfaceRequires a computer equipped with softwa
36、re dedicated to registration management,a driver for encoding,a reading system and a system for checking the quality of the marking.Engraving requires numerous tests and adjustments,sometimes several passes of the machine.Difficult to read small Datamatrix codes Long-term need to re-engrave fading D
37、atamatrix codes.Not suitable for certain instruments,particularly cylindrical or deformed ones.22Optical reading of a Datamatrix code on the user-engraved instrument using a laser Laser marking is based on the use of a light beam,which heats the material to 2500C in a targeted zone,causing the surfa
38、ce of the material to melt.Laser marking quality depends on several parameters:the lasers characteristics,the parameters set by the operators,the properties of the surface to be marked.In the case of stainless steel,quality depends in particular on the alloy and brightness of the steel to be marked.
39、There are many parameters to master in order to obtain a clean,visible marking without causing corrosion on the surface.Various techniques for tracing a surgical instrument23Optical reading of a Datamatrix code on the user-engraved instrument using a laserVarious techniques for tracing a surgical in
40、strument+-Laser engravers produce permanent,high-contrast marks on medical devices,ensuring that datamatrix are visible and legible.Ensures operational precision and does not come into direct contact with surgical instruments,so theres no mechanical alteration or vibration to weaken metals.Marking i
41、s robust and can withstand harsh environments and conditions.Few or no consumables,Versatile on countless materials-metals,plastics,silicone-depending on the settings specified.More expensive and require a risk analysis before purchase(Cost of professional machine is high 45,000)Different models and
42、 features need to be analyzed before purchase,often requiring the advice of experts we are not.Requires specific training(for use,for safety measures)Engraving cannot be improvised.Entrusted to a team member with a specific profile and serious training.Training covers the use of the machine,where to
43、 engrave the datamatrix,what size to give it,which machine programs to use according to the materials,and requires numerous tests before production.24Optical reading of a Datamatrix code on an instrument fitted with Structobond Structobond is a label pre-printed with a Data Matrix.A strip of epoxy r
44、esin glue coats the label,which is then perfectly fixed.It is glued to the pre-sanded surface of the instrument,then baked in an oven at 180C for 30 minutes.Various techniques for tracing a surgical instrument+-Controlled and certified biocompatibility labelsCompatible with most surgical instrument
45、finishesHighly resistant to detergents,mechanical stress and wear and tearIdeal alternative to laser marking or engravingCan be organized by colorLabels pre-manufactured and stored in a freezer at minus 18C.Purchase of labels,freezer,sandblaster(+sand),ovenInstrument must rest for 72 hours after hea
46、tingLimited to certain flat surfaces,e.g.cupules,wide instruments,etc.25Optical reading of a Datamatrix code on an instrument fitted with a Keydot by the user.KeyDot is a small,laser-engraved 2D Data Matrix barcode label that can be applied directly to the surface of an instrument.It holds well on i
47、nstruments made of stainless steel or thermoset polymer(medical-grade plastic).Requires a certain dexterity and a strict procedure to apply it,placing the Keydoton the DM with fine tweezers and securing it to the instrument with the ball side of an ad-hoc paddle.Various techniques for tracing a surg
48、ical 26Optical reading of a Datamatrix code on an instrument fitted with a Keydot by the user.Various techniques for tracing a surgical instrument+-Can be set up by any professional skilled in surgical instrumentationCan be fitted in-house(no need to send to a service provider,and no equipment immob
49、ilization).No damage to the instrument,and easy to identify on the instrument itselfThe choice guided by the type of DM to be identified,its material and shape.For example,an ear speculum,even if made of metal,cannot be engraved because of its round shape.A Keydot can be applied to it.Code alteratio
50、n due to fragmentation,detachment or deformation of the padRequires flat surfaces large enough for pad diameterPossible code degradationRequires dexterity and strict procedure for applicationMust be left to rest for 72 hours before a full sterilization procedure.Glued and could,by definition,come un
51、stuck.Not recommended by the SHC in Belgium.27Automatic recognition of instrument by RFIDThe RFID(Radio Frequency Identification)chips welded onto instruments instruments use a radio-frequency identification system.RFID registration is a technology that enables data to be collected without physical
52、or optical contact.The chips memory capacity is 128 bits,i.e.at least 256 alphanumeric characters.There are two possible solutions:either the chip is soldered onto the element,which may interfere with the operating gesture or the articulation of the instrument,or it is encapsulated in the thickness
53、of the stainless steel when the instrument is created.Various techniques for tracing a surgical instrumentwww.hy- recognition of instrument by RFIDVarious techniques for tracing a surgical instrument+-Reading speed:a complete basket of instruments can be scanned simultaneously by the reader,Storage
54、capacity:greater number of charactersPossibility to modify the contents of the chip.Reliable link to the instrument,as RFID chips are soldered or encapsulated,Data collection at the packaging stage,but also at the end of surgery or during sterilization cleaning under unfavorable conditions(presence
55、of organic or liquid residues)vs datamatrix.Robustness:no chemical,thermal or mechanical alteration due to the constraints of the instruments life cycle.Choice between passive and active chips,Risk of environmental interference(operating room),reception sensitivity(metal vs metal).Difficult to imple
56、ment for existing equipment:hollowing out the instruments,Chip location to be determined in consultation with users.Long instrument downtime,as instruments must be processed by a service provider incorporating RFID chips,High cost compared with laser or micropercussionengraving of data matrix codes.
57、A prototype Smart Tool with an RFID chip and antenna attached to it,allowing for automated surgical tool tracking and counting.Credit:Wyss Institute at Harvard29Various techniques for tracing a surgical instrument30Automatic recognition of instrument by algorithm:shape,weight,colorThese solutions ca
58、n be applied to surgical instruments,particularly for ready-to-use sets where trays are designed to organize instruments in unambiguous supports.These devices measure object presence,weight,shape or color.Help operators reassembling surgical trays to identify and track surgical instruments,with or w
59、ithout DataMatrix codes,and validate their location on the tray.The systems algorithm identifies all types of reusable surgical devices and ensures their traceability(with or without DataMatrix code),based on their basic physical characteristics.Various techniques for tracing a surgical recognition
60、of instrument by algorithm:shape,weight,colorVarious techniques for tracing a surgical instrument+-Creating a full picturized database of loan sets and surgical traysFacilitating communication between hospitals and vendorsSupport during assembly processesSharing and creating reports,reservation and
61、order forms,and maintenance data.Linking specific instruments to a tray or a kitProviding smooth integration to a hospitals existing IT systeman easy-to-use,reliable tool for safe re-composition of ancillary equipment by operators.Highlights the difficulty of validating the precise composition of an
62、cillariesSupports a portion of surgical instruments,in certain configurationsHigh price for use limited mainly to loaner sets,but profitable for large CSSDsRegular encoding of new sets and instruments requiredRecomposition at the tray could be an aid when returning ancillary equipment on temporary d
63、eposit with the supplier.Further development and qualification of the tool is required(interfaces)It is not really traceability by instrument.32AI(Artificial Intelligence)recognition in CSSD Computer vision systems image segmentation,object detection,pattern recognition,machine learning,neural netwo
64、rks,depth sensors or infrared camera.Various techniques for tracing a surgical instrument33AI(Artificial Intelligence)recognition in CSSD “ChatGPT”Potential future uses of artificial intelligence in the field of surgical instrument sterilization.AI could be used to automate and improve sterilization
65、 processes,helping to detect contaminants or defects on instruments,optimizing sterilization cycles according to instrument types,providing recommendations for the care and maintenance of sterilization equipment,track and trace instruments throughout their lifecycle.Implementation of these technolog
66、ies will require rigorous validation and compliance with current regulations to guarantee the safety and efficiency of sterilization processes.Various techniques for tracing a surgical instrument34ConclusionIndividual traceability of instruments is generally implemented to:prevent the risk of contam
67、ination;reinforce the ability to identify and recall instruments for material vigilance purposes or maintenance(communication);as a tool for managing technical resources;to monitor the quality of practices;reduce the risk of errors and instrument mix-ups;Accelerate the training for the news hires.To
68、day,it is note yet an obligation!35ConclusionNot possible today to choose a single marking technology:great diversity of instruments in terms of size,shape and material,We take care to not compromise instrument safety and performance.We hope that this brief overview of the various instrument identif
69、ication techniques will help you to make your choice of tools and approaches in line with legislation and recommendations,as well as your economic,technological and human resources.36ConclusionCARE-NAM:our specific situation For us,its obvious that instrument traceability is very important to make o
70、ur process consistent!Even before the launch of CARE-NAM!Whenever possible,we read the suppliers datamatrix.For all other existing instruments in the 3 hospitals,we have opted for in-house laser engraving,and we have acquired a laser engraver to engrave our old instruments.We also use outsourcing(lo
71、cal supplier).We start with the traceability of unique and individual instruments.Engraving is only part of the project-reading is also IMPORTANT!37Thank a lot toBelindaDavidOlivierBenoit38Thank you for your attention39BibliographyValrie Jacob Corazza.Retour dexprience de la traabilit linstrument la
72、 strilisation du Centre Hospitalier dAls.2mes JIFS Marrakech 2014(Dia 10)Les codes 2D en bref:quelle est la diffrence entre un code Data Matrix et un QR code?https:/www.domino- Visite du site le 5/09/2023Superior Health Council.Good practices for the management of reusable medical devices.Revision o
73、f the recommendations on sterilisation(SHC 9256-2017).Brussels:SHC;2023.Report 9682.Guillaume Prom.ANSM LISTE Dispositifs mdicaux dclars l ANSM.Liste des communications par les fabricants,lANSM,de dispositifs des classes IIa,IIb et III et de DMIA.10/2020.https:/ du site le 17/09/2023.Yoann Cot.Nouve
74、lle mthode didentification et denregistrement des plateaux dinstruments chirurgicaux en strilisation:critres de choix du marquage laser et mthodo/logie de mise en place.Sciences pharmaceutiques.2019.dumas-02325673LECTROCHIMIQUE.https:/ Visite du site le 18/09/2023C.Caussette et al.Mthodes de marquag
75、e et de traabilit pour sassurer de la strilisation des instruments chirurgicaux.Techniques hospitalieres,juillet-aot 2020.D.Talon et al.Traabilit des instruments de chirurgie re-strilisables:apport de la technologie RFID.ASEPTIC SURGERY FORUM 2010.https:/www.sterilisation- Visite du site 19/08/2023S
76、mart Tools:RFID Tracking for Surgical Instruments.https:/wyss.harvard.edu/technology/smart-tools-rfid-tracking-for-surgical-instruments/Visite du site 8/09/2023Martocq N.et al.MISE EN PLACE DUN OUTIL DAIDE A LA RECOMPOSITION DES ANCILLAIRES EN STERILISATION CENTRALE.Poster prsent lors du 3me congrs
77、de la SF2S.09/2019.https:/www.sf2s-sterilisation.fr/wp-content/uploads/2019/11/PO-20.pdf Visitedu site le 10/10/2023404142Whats the difference between a Data Matrix and a QR code?Code typeData Matrix codeQR codeMaximum capacityNumeric:3116Alphanumeric:2335Byte:1556Numeric:7089Alphanumeric:4296Byte:2
78、953Dimension10 x 10 144 x 144 cells21 x 21 177 x 177 cellsError correctionReed-Solomon algorithm25-33%error correction capabilityReed-Solomon algorithmError correction for QR codes can be adjustedApplicationSupply chain traceability,direct marking for electronic componentsAnti-counterfeiting via ser
79、ializationThe only GS1-approved 2D codes for regulated healthcare products.Additional product information-Instructions for use and recipes-Social network communication-Automatic links for spare parts orders and warranty registration-Promotions,contests and gameshttps:/www.domino- the difference betw
80、een Barcode/Data Matrix/QR code?Code typeBarcodeData Matrix codeQR codeMaximum capacityBetween 8 and 13 caractersIt stores less information than QR codesNumeric:3116Alphanumeric:2335Byte:1556Numeric:7089Alphanumeric:4296Byte:2953Dimensionmore than 100 bytes10 x 10 144 x 144 cells21 x 21 177 x 177 ce
81、llsError correctionNot possible to assess the quality of a linear barcode Reed-Solomon algorithm25-33%error correction capabilityReed-Solomon algorithmError correction for QR codes adjustedApplicationA standard barcode may be able to tell a product number and its expected location,but that would be
82、it.Inventory managementLibrary bookSupply chain traceability,direct marking for electronic componentsAnti-counterfeiting via serializationThe only GS1-approved 2D codes for regulated healthcare products.Additional product information-Instructions for use and recipes-Social network communication-Automatic links for spare parts orders and warranty registration-Promotions,contests and gameshttps:/www.domino-