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Unique Device Identification: Manufacturer, Hospital and Global Implications

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Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.

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Unique Device Identification: Manufacturer, Hospital and Global Implications

  1. 1. visit usdm.com Welcome to USDM Life Sciences visit usdm.com Unique Device Identification – Manufacturer, Hospital, and Global Implications
  2. 2. 2 Introductions Grant Hodgkins VP Commercial Services and Solutions, USDM Life Sciences • Three decades of Pharmaceutical and Medical Device manufacturing experience including Track and Trace, Medical Device UDI, GS1 standards adoption, ERP, MES, Master Data Management, and other enterprise solutions. • Drove UDI and Master Data Management initiatives for over 75 engagements. • Recently, Head of Global Data Management at major Medical Device/Pharma/Consumer firm. • At USDM Life Sciences, focuses on providing business process, technology and compliance solutions for the regulated life science industry. INTRODUCTION
  3. 3. 3 • UDI - Current State of Play • Key Differences (Global vs. US FDA UDI) • UDI Challenges (Implant Traceability, Convenience Kits, Direct Mark, Scanning) • Hospital / Clinician Viewpoints on UDI • What’s Next? • Question and Answer Agenda / Topics for Today INTRODUCTION
  4. 4. 4Presentation ID 0000 • UDI’s impact on instruments, including longevity of laser marking on reusable instruments • Current requirements for small implants • EU requirements • Types of bar codes • Recommendations for AIDC on round surfaces and the abilities of readers to capture the information • How do I mark multi-component devices for top level UDI (e.g., devices where components could be interchanged or swapped)? • What is the guidance on UDI of an injection molded implant that will not have unique lot information molded into the implant (only part number)? Questions Submitted by Attendees INTRODUCTION
  5. 5. Current State of Play
  6. 6. 6 Are you positioned to efficiently address additional UDI regulations? • EU MDR and IVDR regulations – approved and in-force (starting 26-May-2017) • Several additional countries in progress • Every new regulation introduces additional complexities: – New attributes (additional to GUDID) – Local language translations of existing attributes (e.g., Description) – Conversions of attributes (e.g., imperial to metric, True/False to Y/N) – Different mechanisms to upload UDI data to government databases • You have a business to run, and don’t want a ‘perpetual’ UDI project The Challenge – Growing UDI Requirements… STATE OF PLAY
  7. 7. 7 US UDI EU MDR UK NHS Regulatory Requirements “Commercial” or (Ministry of) Health/Cost/Import Control Requirements UK NHS Qatar (all devices) In the US – Also IDNs (Kaiser); GPOs ONC/EHRs, CMS South Korea – 2019-2022 India – 2022 Saudi Arabia – ~2019 Netherlands – 1 July 2018 (implants) Taiwan – ~2018-2020 Canada – “IMDRF”? China – Summer 2018 (reg) Singapore – coming… Traceability Implant Registries (several + VA) The Evolving UDI Global Landscape (GHTF/IMDRF based) UDI REGULATIONS
  8. 8. 8 IMDRF Guidance – Goal Largely Realized CONFIDENTIAL- Copyright USDM Life Sciences - 2018 UDI REGULATIONS
  9. 9. 9 Various needs to meet multiple regulatory and commercial purposes. • In the US – tying together device meta-data (e.g., brand name, device attributes), premarket (e.g., 510k, PMA), and Registration and Listing (R&L – listing number – used for import control) • In the EU – similar – but more… (see next slides) • In the UK – GDSN product/packaging data • Other countries… where is it manufactured (country of origin – is that product allowed in that country?), who (contract) manufactured it, parent- child relationships (parent-accessory relationships), contents of kits, combination products…? Exponentially Growing Data Needs CONFIDENTIAL- Copyright USDM Life Sciences - 2018 EU UDI SYSTEM
  10. 10. 10 It will apply (date of application): - for MDR – three years after entry into force [26 May 2020] - for IVDR – five years after entry into force [26 May 2022] Article 29 1-2 – Registration of devices – due the later of the date of application or 6 months after publication of notice in Article 34(3): Before placing a device, system or procedure pack … on the market, the manufacturer shall … assign a Basic UDI-DI … and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI… Implementation – UDI Database CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION
  11. 11. 11 The UDI carrier must be placed on the label of the device and on all higher levels of packaging: • For implantable and Class III devices/class D IVDs – 1 year after the date of application [26 May 2021/2023] • For Class IIa and Class IIb devices/class B and C IVDs – 3 years after the date of application [26 May 2023/2025] • For Class I devices/Class A IVDs – 5 years after the date of application [26 May 2025/2027]. For reusable devices that require UDI Carrier on the device itself: • 2 years after the applicable class compliance date. Implementation – Label and Packages CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION
  12. 12. 12 • As in the US, largely based on GHTF + IMDRF UDI guidances • UDI assigned/marked with AIDC+HRI on device labels & packages • Use of global Issuing Agencies (GS1, HIBCC, ICCBBA) • UDI for accessories, systems (and configurable devices), and procedure packs/convenience kits • “Combination products” – if regulated as device – needs UDI • UDI for SaS/SaMD in embedded screen and label/physical media • Shipping containers, custom and investigational devices – exempt • PIs (generally) not specified • Retail/POS do not require PIs in UDI (US class I, others by request) Implementation – US UDI Similarities (1/2) CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION
  13. 13. 13 • Technology neutral approach (no specific AIDC required) • Reusable devices need “direct mark” (permanent) UDI on device • UDI for implants MUST be identifiable prior to implantation. • UDI Database – submit (static) core data attributes for each device • Data for a new UDI-DI must be entered before the device is placed on the market; other changes within 30 days. • New UDI-DI is required when there is a change to the device or in certain UDI Database fields • Barcode verification • Additional guidance being developed by MedTech Europe (in progress; first draft released last week) Implementation – US UDI Similarities (2/2) CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION
  14. 14. 14 • Responsibility: US Labeler vs EU Manufacturer • SUD packaging exception: EU limited to class I/IIa [/class A/B] – also, less restrictions (SUD and individually labeled and packaged) • Procedure packs (aka “convenience kits”) and Systems: EU individual devices must ALSO be UDI compliant – unless SUD or already exempted • Configurable device: EU UDI on separately distributed components • IVD Kits: EU UDI ALSO for individually distributed reagents and articles (but not parts of kit) • Standardized date format (YYYY-MM-DD): EU not required Implementation – US UDI Differences (1/2) CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION
  15. 15. 15 • Software: EU label and software UDI must be identical • Class I devices: EU needs both DI and PI • DM UDI: EU UDI must be both AIDC and HRI (still unclear…) • Direct Mark: EU does NOT exempt devices that are only cleaned between different patient use and single patient use. • “Existing inventory” exemption: EU does not have Implementation – US UDI Differences (2/2) CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION
  16. 16. 16Medical Device | Global UDI & MDM Webinar | USDM.com UDI Requirement US EU UK NHS Basic UDI-DI No Yes – required for registration Likely to follow EU Responsibility Labeler Manufacturer Likely to follow EU SUD Packaging Exception All devices except implants Limited to Class I/IIa Likely to follow EU Procedure Packs (kits) & Systems Pack/System Label only Individual devices must also be UDI compliant – unless SUD or already exempted Likely to follow EU Configurable device N/A UDI required on separately distributed components Likely to follow EU Standardized date format (YYYY-MM-DD) Required Not required Not required Software Label and software UDI not required to be identical Label and software UDI must be identical Likely to follow EU GMP-exempt Class I devices UDI not required Not exempted Likely to follow EU Class I devices DI only required DI & PI required Likely to follow EU Direct Mark UDI AIDC and/or HRI AIDC and HRI required Not applicable – commercial transactions Direct Mark Exempts “Clean Only” devices Does not exempt “Clean Only” devices between different patient use and single patient use Not applicable – commercial transactions “Existing inventory” exemption 3 year post compliance date Not exempted Not applicable – commercial requirement IMPLEMENTATION
  17. 17. 17 Implementation – Database Similarities CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION US GUDID EU Eudamed 1 Primary DI number (and issuing agency) UDI-DI 2 Labeler company name and physical address (as represented by labeler DUNS) Name and address of the manufacturer (as on the label), 3 Brand name Name or trade name (optional) 4 Version or model Device model, reference, or catalogue number (optional)5 Catalog number (optional) 6 Device description (optional) Additional product description (optional) 7 Clinically relevant size (size type, size value, and size unit of measure – or size type text) Clinical size – including volume, length, gauge, diameter (optional) 8 Production identifier(s) – lot or batch number, manufacturing date, serial number, expiration date, and/or donation identification number Manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number) 9 For single-use (y/n) Labelled as a single-use device (y/n) 10 Device packaged as sterile (y/n) Device labelled sterile (y/n) 11 Requires sterilization prior to use (y/n) Need for sterilisation before use (y/n) 12 Device labeled as containing natural rubber latex or dry natural rubber (y/n) Containing latex (y/n) 13 Storage and handling (type, low value, high value, and unit of measure) Storage and/or handling conditions – as indicated on the label or in the instructions for use (optional) 14 Device Count (for primary DI) Quantity per package configuration 15 Package DI number Quantity per package Contains DI package 16 Unit of use DI number The unit of use UDI-DI 17 DI record publish date Commercial distribution end date Status of the device (on the market, no longer placed on the market
  18. 18. 18 Implementation – Database Differences CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION Unique US GUDID Attributes Unique EU Eudamed Attributes Labeler DUNS Number (Company Name and Company Physical Address) The Basic UDI-DI Secondary DI Number (and Issuing Agency) The Single Registration Number (SRN) Device subject to direct marking DM), but exempt If applicable, name and address of the authorised representative (as on the label) DM DI different from primary DI (and DM DI number) If applicable, additional trade names of the device Customer Contact – phone and email Risk class of the device Prescription use (Rx) and/or Over the Counter (OTC) The medical device nomenclature code as provided for in Article 26 Device is also a HCT/P, kit and/or combination product If applicable, the maximum number of reuses Premarket submission number (PMA, PMA supplement number, 510k, or device exempt) Where applicable, information labelled in accordance with Section 10.4.5 of Annex I FDA product code (auto-populates product code name) URL for additional information, such as electronic instructions for use (optional) FDA listing number If applicable, critical warnings or contra- indications GMDN code (auto-populates name and definition) Status – recalled, field safety corrective action initiated Device labeled as "Not made with natural rubber latex" MRI safety status (safe, unsafe, or conditional – or label does not contain) Special storage conditions Sterilization method (specified list of values) Package type
  19. 19. 19 These fields, which are common to GUDID and Eudamed, MAY need to be translated into the 24 official languages of the EU: 1. Name or trade name 2. Additional product description 3. Clinical size – including volume, length, gauge, diameter 4. Storage and/or handling conditions – as indicated on label or IFU 5. Additional trade names of the device 6. Critical warnings or contra-indications This adds another layer of complexity and overall effort… Implementation – Database Translations CONFIDENTIAL- Copyright USDM Life Sciences - 2018 IMPLEMENTATION
  20. 20. What Is Needed to Succeed
  21. 21. 21 • Deep understanding of the specifics of the regulations and how they affect you • Re-assess current UDI program vs. new/emerging requirements • One Source of Truth to house and easily share your key attribute data • Highly-flexible data models, workflows, and uploads to government databases • Integrated solutions with fast deployment, validation, and startup • Meet these requirements while maximizing business operations and reducing costs • Your Destination: A UDI ‘Capability’, not a perpetual UDI project What Is Needed to Succeed SUCCESS FACTORS
  22. 22. 22 • Current UDI compliance programs were (necessarily) quickly enacted to meet aggressive FDA timelines • We all learned a LOT from these initial projects, what worked, areas to improve, what we should do differently in the future • For EU and other countries, we now have time to re- evaluate, optimize, and convert UDI initiatives into sustainable, operational capabilities • This window of time for re-evaluation is quickly closing and should not be missed (once in a career opportunity) Why Now? SUCCESS FACTORS
  23. 23. Back to Basics – Master Data
  24. 24. 24 MDM – Digitally Representing Physical Objects CONFIDENTIAL- Copyright USDM Life Sciences - 2018 MASTER DATA MGT
  25. 25. 25 1. For US – about 60 attributes 2. For UK – about 20 additional/new attributes 3. For EU – about 100 additional/new attributes 4. Other countries/regulators…? Needs: • Robust, scalable master data solution to store, maintain, and submit data attributes • Scalable processes to efficiently gather and confirm new attributes and relationships • Connections to move this data to GDSN (e.g., UK) and regulators (e.g., EU) Master Data Management Challenges CONFIDENTIAL- Copyright USDM Life Sciences - 2018 MASTER DATA MGT
  26. 26. 26 Example – Data Model Considerations CONFIDENTIAL- Copyright USDM Life Sciences - 2018 • One product may have multiple entries (by packaging level) • Name and Address may differ – based on differing requirements • Registration numbers will differ – across jurisdictions • Descriptions may differ – 26 approved EU languages – only 3 modeled here • Some attributes only for US (510K), some only for EU (EU Max Re-Uses) MASTER DATA MGT Catalog Number UOM Description (EN) Description (FR) Description (ES) US 510K EU SRN EU BUDI-DI EU Max Re-Uses US Device Class EU Risk Class US Name & Address EU Name & Address 1006 EA Cannula 15mm Canule 15mm Aguja 15mm K10000 19054-934 0123456000009 25 II Iib MedDev Partners 2000 Main Street Anytown, MM 99001 MedDev Group Inc. 1402 Production Way Smalltown, YY 00089 1006 BX Cannula 15mm Canule 15mm Aguja 15mm K10000 19054-934 0123456000009 25 II Iib MedDev Partners 2000 Main Street Anytown, MM 99001 MedDev Group Inc. 1402 Production Way Smalltown, YY 00089 1006 CA Cannula 15mm Canule 15mm Aguja 15mm K10000 19054-934 0123456000009 25 II Iib MedDev Partners 2000 Main Street Anytown, MM 99001 MedDev Group Inc. 1402 Production Way Smalltown, YY 00089
  27. 27. 27 CONFIDENTIAL- Copyright USDM Life Sciences - 2018 Global UDI Internal Ops Customer Requirements US UDI MASTER DATA MGT Single Source of Truth
  28. 28. 28 MDM, PIM, PLM, PDM…What is This? CONFIDENTIAL- Copyright USDM Life Sciences - 2018 MASTER DATA MGT
  29. 29. 29 Possible Single Source of Truth Model… CONFIDENTIAL- Copyright USDM Life Sciences - 2018 MASTER DATA MGT
  30. 30. Back to Your Questions…
  31. 31. 31Vertical ID| Foucs | USDM.com Presentation ID 0000 • UDI’s impact on instruments, including longevity of laser marking on reusable instruments • Current requirements for small implants • EU requirements • Types of bar codes • Recommendations for AIDC on round surfaces and the abilities of readers to capture the information • How do I mark multi-component devices for top level UDI (e.g., devices where components could be interchanged or swapped)? • What is the guidance on UDI of an injection molded implant that will not have unique lot information molded into the implant (only part number)? Questions Submitted by Attendees INTRODUCTION
  32. 32. 33Vertical ID| Foucs | USDM.com Presentation ID 0000 • Grant Hodgkins – ghodgkins@usdm.com • Jay Crowley – jcrowley@usdm.com • Jim Macdonell – jmacdonell@usdm.com Contact Information INTRODUCTION
  33. 33. All great changes are preceded by chaos. — DEEPAK CHOPRA UDI Adoption
  34. 34. AHRMM Learning UDI Community: shared responsibility • The AHRMM Learning UDI Community is a healthcare collaborative effort designed to address issues impacting the implementation and use of unique device identifiers by developing a common understanding and approach to UDI adoption within the healthcare setting. • Establishing a consistent and unbiased platform for collaboration, communication, and education between all healthcare stakeholders • LUC membership and content is open to all those who are interested in advancing UDI adoption within the healthcare field. • Seek. Solve. Share.
  35. 35. • UDI Capture Case Studies • Unit of Use Report and Webcast series • Clinically Relevant Size work group Report • Catalog Number work group Report • Low Unit of Measure Supply Chain Recommended Practices Report • Business Case for the Benefits of UDI Comprehensive Report and Presentation • Human Cellular Tissue Product Guidance Document and Presentation LUC Resource Center: recommended practices
  36. 36. • GUDID Data Quality White Paper Series • Barcodes at the Point of Care • Multiple Device Identifiers • Clinically Relevant Size • Device Categorization • High Risk Implant List LUC: active work groups
  37. 37. UDI: it’s all about the data • Data – is as important as the product • Data – is the foundation of the transactional supply chain • Data – is the foundation of clinical use • Data – is the foundation of the electronic health record • Data – is the foundation of regulatory compliance • Data – is the foundation of post market surveillance and recalls • The request is always for more data, not less
  38. 38. Sources of Truth * Item Master Supply Chain Orders EHR Inventory OR Information Systems * Global UDI Database And many more Real world evidence Charge Master/ Patient Billing Providers need to make sure their item master has data to feed multiple systems and processes. * Write once, read many
  39. 39. • Device identification in registries: • AJRR – American Joint Replacement Registry • NCDR – National Cardiovascular Data Registry • Comparative effectiveness • Documenting medical device use in patient’s EHR/PHR, hospital information systems, and claims data • Sentinel Initiative and other post-market surveillance activities • Contracting • Physician Preference • Clinical trials – combined with Genomics Consumption of the UDI
  40. 40. GUDID Data Quality • Consistency – provider organizations wanting to leverage UDIs for cost, quality, and outcomes initiatives is the inability to access consistent data. • Crosswalk – Providers have stated that they cannot match legacy data in existing ERP systems to UDI-DI records in the GUDID, and that the data they do match may contain values that are inconsistent or incomplete to support their supply chain or clinical requirements.
  41. 41. 10 GUDID Records Submission Compliance Deadlines Data Current as of May 1, 2018 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 1,400,000 1,600,000 1,800,000 2,000,000 Class I & Unclassified Class II I/LS/LS Class III
  42. 42. Barcodes at the Point of Care • Multiple Bar codes on the label • Scanners unable to read additional segments, i.e., application identifiers • Barcode only on the box and not on the device
  43. 43. Multiple Device Identifiers • Records with the same Brand Name, Version and Model, but different Device Identifier • LUC Workgroup is addressing through a multidisciplinary stakeholder work group – Issuing Agency DI rules – Mfg. business drivers and internal processes – Impact to Provider and patient care setting – Recommended Practice to reduce MDIs
  44. 44. Multiple Device Identifiers Hospital Item Master Brand Name MaxStent Manufacturer MedSup Catalog 1245 Device ID Brand Name MaxStent Device ID 00999911000012 Catalog 1245 Company MedSup Brand Name MaxStent Device ID 00999911000013 Catalog 1245 Company MedSup
  45. 45. Clinically Relevant Size There are four fields within the GUDID that capture components of device size: • SizeType: a constrained list, intended to be the measurement type (length, width, height, etc.) • Unit: a constrained subset list of the Logical Observation Identifiers Names and Codes (LOINC) for Unified Code of Unit Measure (UCUM), intended to be the unit of measure (e.g. inches, cm, mm, etc.) • Value: the numeric value of the size measurement • SizeText: analog text, intended to capture information not represented in the sizeType, unit and value fields
  46. 46. Clinically Relevant Size There appear to be several reasons for the CRS data quality issues: • GUDID field names for CRS parameters that are not completely intuitive • Incomplete or otherwise inadequate instructions for the completion of the CRS data fields • Value set selection lists that are incomplete or do not have a term to represent a dimension of measurement • Hesitation by manufacturers (and labelers) to use said fields
  47. 47. Structured, discrete, and useful MedSup1 DI: 007331326361 05 MedSup2 DI: 0082168406210 4 Clinically Relevant Size
  48. 48. Value to Multiple Stakeholders • Less paperwork • Less time looking for, counting supplies • Visibility to which products improve quality AND cost and for which patients • Confidence that she knows they can find her if there is a recall. • Real world evidence (RWE) to: • Better market and design products • Achieve faster regulatory approvals
  49. 49. • Learning UDI Community (LUC): http://www.ahrmm.org/LUC • Unique Device Identification-UDI http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ • UDI Basics http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm • AccessGUDID (for the public) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/u cm444831.htm • UDI Resources http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ChangesbetweenUDIPropose dandFinalRules/default.htm • SMI Report: Introducing UDI Labeling Strategies into the Surgical Setting http://www.smisupplychain.com/index.php?option=com_content&view=article&id=49:20151008_udi-labeling&catid=24:pr or http://www.smisupplychain.com/tools • Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation. Engelberg Center for Health Care Reform at Brookings. December 2014. https://www.brookings.edu/research/unique-device-identifiers-udis-a-roadmap-for-effective- implementation/ • Unique Device Identifier (UDI). AdvaMed. http://advamed.org/issues/9/unique-device-identifier-udi References
  50. 50. How to Use a Universal UDI Scanning and Documentation System to Track All Implants and Supplies…Including the Tough Ones - Hospital-Sterilized Medical Implants Presented at OMTEC 2018 by Larry Donnelly 940 W. Oakland Ave., Suite A-10 Oakland, Florida 34787 LDonnelly@MatrixIT.io www.MatrixThis.com
  51. 51. Compliance Landscape • Medical device companies must begin providing Unique Device Identifiers (UDI) for all medical devices, which are traced through the product’s lifecycle. • In the U.S., the FDA, ONC and Medicare regulate UDI compliance. • In the EU, the European Commission established MDR to fulfill new UDI requirements. • The FDA Final Rule and MDR recommends direct part marking as an effective means to permanently identify hospital sterilized implants and the use of AIDC technology to collect UDI information.
  52. 52. Problem • Hospital sterilized devices lose all UDI information when removed from their packaging and placed into sets with identical implants. • The UDI must be collected at the point of care (during surgery; at the point of implantation), and transferred to the hospital EHR system, where that information will be submitted to government payers. • Typical scanners may not be used to collect direct marked UDI information for these devices, since they are non-sterile and cannot capture data from “micronized” data matrix codes. • Other UDI collection methods may be space prohibitive, expensive, inaccurate and could increase surgical times.
  53. 53. Direct Mark Using Scanners Sterile Packaging/RFID Sterilizable Tag Manual Callout Cross Reference Sheet Other UDI Options • Device manufacturers must provide UDI compliant products. However, the approaches that they plan to deliver UDIs to hospitals vary widely, including manual call out, reference sheets and sterile packaging. • The UDI on Operating Room products will be conveyed in many forms, but hospitals must be prepared to collect all UDI options by a Universal UDI Documentation System. • The method selected will impact case time and data integrity, cost and staffing. • Direct part mark sterile field scanning is the only method that collects all UDI at the point of implantation; and does not introduce human error, increase hospital staffing, slow down surgical pace, require sterile breach monitoring, expiration data tracking or increase storage requirements.
  54. 54. UDI Direct Part Mark and Sterile Scanning Benefits • Remove potential for human error • Ensure visibility of all devices from manufacture to implantation to removal. • Efficient electronic UDI capture and accuracy, without slowing surgery or increasing staff. • Integrate transmission of case data to the hospital EHR and manufacturer. • Correlate device data to the patient’s implanted anatomical locations. • Capture all other implant and supply information through the handheld scanner. • Verify, through recall databases, that no recall exists and product is not expired
  55. 55. What is “Technologically Feasible?” Aneurism Clip Marked with 30 Micron Data Matrix Code Cell Size: Read by Tractus
  56. 56. Track Inventory Electronically From Manufacture to Implantation • Mark and verify implants with UDI compliant data matrix codes. • With existing software platforms, manufacturers may scan each device and place them in a set, matching each device with that set, and matching each set with a tray. • Once configured, scan the tray and assign it to a rep, distributor or hospital. All devices inside of tray are now visible. • Hospital manages tray visibility and captures UDI information during surgery. That information is instantly sent to the manufacturer. • After each case, replenish the tray in preparation for a new case.
  57. 57. Point of Implantation UDI Capture and Documentation Scan – Document - Report Sterile Field ScannerHandheld Scanners/RFID Documentation Software 0.3mm^2 Data Matrix readability
  58. 58. Operating Room Implant Documentation Process • Surgeon calls for an implant. • If hospital sterilized or tagged, the scrub tech selects a UDI direct marked implant from a sterile set, and scans the data matrix code containing the UDI with the Tractus scanner. • If packaged, the “non-sterile nurse” opens the package and drops the device onto the sterile table, where the scrub tech collects it and hands it off to the surgeon. • Device data is transmitted to the circulating nurse’s computer software system. • Circulator correlates the device to the implanted anatomical location. • Wasted and explanted devices are moved into the software’s “Discarded Bin,” with discard reason selected. • After completion, case data is transferred to the hospital EHR system and manufacturer or distributor
  59. 59. Implant Summary Report • Integrates with recalls database, master inventory and EHR systems. • Correlates UDI and catalog numbers • UDI is presented in universal language format. • UDI is conveyed via AIDC, the preferred data collection method. • Interfaces with GUDID and MAUDE. • All components are battery powered with wireless data transmission capability. • Sends inventory utilization in real time to EHR and the manufacturer. The AIDC System is compatible with all currently identified UDI tracking solutions, including reference sheets, human readable manual callout, data carrier tags, RFID, handheld scanners, smart device app., sterile packaging and Direct Mark (DM).
  60. 60. Observations • 100% accurate UDI data collection, in real time during surgery • Integrated into existing processes, without surgical flow disruption • Staff documentation time decreased • Information seamlessly transferred to the hospital EHR system. • Reduction of case times via electronic data capture • Potential for human error eliminated • Draping of the scanner was easy, and could be performed several ways. • Scanned device UDIs were collected, with no negative effects to the case flow or surgical times • Easy scanning, software management, and anatomical device assignment
  61. 61. Questions? Presented at OMTEC 2018 by Larry Donnelly LDonnelly@MatrixIT.io www.MatrixThis.com
  62. 62. Different Direct Part Mark Results The Right Equipment and Expertise are Critical to Success Damaged Data Matrix Code Damaged Human Readable Mark Good Data Matrix Code
  63. 63. Reference Material

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