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Ass. Prof. Dr. Gerold Labek EFORT European Arthroplasty Register Coordinator

Standard Implant Database rules of engagement: Governance, maintenance, access, funding The European Perspective. Ass. Prof. Dr. Gerold Labek EFORT European Arthroplasty Register Coordinator. Why a European Perspective.

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Ass. Prof. Dr. Gerold Labek EFORT European Arthroplasty Register Coordinator

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  1. Standard Implant Database rules of engagement: Governance, maintenance, access, fundingThe European Perspective Ass. Prof. Dr. Gerold LabekEFORT European Arthroplasty Register Coordinator

  2. Why a European Perspective

  3. Implant Database: Essential for any Register performing Analyses on Outcome of Implants Redundant activities in every country?? EAR-founded: 2002 First Meeting on the topic: 2004 18 Participants 7 Countries European Hip Society,… Applicants to host central implant database (Germany – Turkey) Why a European Perspective?

  4. Consensus 2004: No register shall host the standard database Funding, responsabilities,..? Dominating role in the system  risk for national autonomy IT Service Provider Too complex and expensive for a standing alone solution by a scientific society like EAR or EFORT – even in Europe On our agenda for > 10 years now Experiences on pitfalls and success cases Why a European Perspective?

  5. Development on National Registries Everyone struggled to realise and implement Quality is dependent on the investments possible and cooperation Germany, NJR, NL, Australia advanced systems Only Joint Efforts reasonable including all Stakeholders Time Line and basic observations

  6. Support for ICOR from the very beginning EPRD already a big and professional project on the way Several registries requesting an implant database (NL, SK, RO,…) Announced ICOR In Europe „wait for the global standard solution announced to be available soon“ Proposal to include EPRD at ICOR failed Pending registries established their own database Leiden-Meeting: Re-establish the communication lines and connect EPRD and LROI to the process Time Line and basic observations

  7. Request for access to implant database, no satisfying database existing Update requested Present Situation

  8. EU-MEDDEV

  9. It has an impact on the workflows of any register  complex management task Every Register is working on a structure according to national legislations and circumstances  different Very complex to implement an „additional stakeholder“ in this setting Manufacturers EU-Commission?? FDA, ICOR, ISAR, EAR, EFORT,????? European Experience

  10. Who is funding? Nationally Global level? Responsibilities in case of failures? Second line of defence: National manufacturer „external Stakeholder without position in the national setting??“ Liabilities in case of incorrect final decisions?? Fundamental Change in every National Register System European Experience

  11. Costs, benefits and legal issues: Manufacturers: All for One?If not on a specific market??? FDA in a European Country or vice versa???Acceptable from legal perspective?? Scientific Entities – acceptable as core partner for regulatory processes???? No institution covers all global aspects and partners Regulators (FDA, EU,…) Manufacturers (Advamed, EUCOMED, BV-Med,…) Scientific Societies (ICOR, ISAR, EFORT, EAR,…) European Experience

  12. Respect the legal functions and responsabilities Global Cooperation  additional Stakeholders Don´t re-invent the weel, use existing models and identify best practice Definition on Standard Classification and Glossary is the trivial thing in the entire project Proposal

  13. How could it work? Industry is providing the database and is responsible for updates and validation Coordination between trader associations on all major markets expected to be covered by registries in the next decade(Advamed, EUCOMED, Germany, Japan, Brasil,…)Competences on headquarter level Contracts with Regulators and individual registries Investment and Benefits Access to data to fulfill legal requirements!!! Regulators Proposal

  14. How could it work? Coordination and Scientific Support by research organisations (ICOR, ISAR, EFORT, EAR,…) Consensus on a frame agreement requests, legal limitations and opportunities, processes, interpretation of data, use of data in multiple aspects,…. Roll out in a joint effort and according to development of additional registries Proposal

  15. How could it work? Long term process UDI-Implementation National issues (re-labeling by Distributors and Health care providers) Require stable infrastructure on global level Project level IMDRF Proposal

  16. Global Standardisation Processes

  17. N available TKA 2010 Scandinavia Australia Clinical studies worldwidevs Registries with data validationpublished

  18. Today+ NJR 2025

  19. Home made barcodes Further Manufacturers Further Registries Data access Validation Financing Feedback Cost-Beneift Liabilities in case of errors Workflows Set up + updates

  20. Register data will be essentialFundamenal Change of a complex system

  21. 09/11/2014 21

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