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  • Hoogervorst, Lotje A.Leiden Univ Med Ctr, Dept Orthopaed, Leiden, Netherlands.;Leiden Univ Med Ctr, Dept Biomed Data Sci & Med Decis Making, Leiden, Netherlands (author)

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle : A Systematic Review

  • Article/chapterEnglish2023

Publisher, publication year, extent ...

  • Kerman University of Medical Sciences,2023
  • electronicrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:uu-511607
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-511607URI
  • https://doi.org/10.34172/ijhpm.2023.7648DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:for swepub-publicationtype

Notes

  • Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformite Europeenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

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  • Geurkink, Timon H.Leiden Univ Med Ctr, Dept Orthopaed, Leiden, Netherlands (author)
  • Lübbeke, AnneGeneva Univ Hosp, Div Orthopaed Surg & Traumatol, Geneva, Switzerland.;Univ Geneva, Geneva, Switzerland.;Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskeleta, Oxford, England (author)
  • Buccheri, SergioUppsala universitet,Kardiologi(Swepub:uu)serbu677 (author)
  • Schoones, Jan W.Leiden Univ Med Ctr, Walaeus Lib, Directorate Res Policy, Leiden, Netherlands (author)
  • Torre, MarinaIst Super Sanita, Sci Secretariat Presidency, Rome, Italy (author)
  • Laricchiuta, PaolaIst Super Sanita, Sci Secretariat Presidency, Rome, Italy (author)
  • Piscoi, PaulEuropean Commiss, Hlth Technol Unit B6, Directorate Gen Hlth DG SANTE, Brussels, Belgium (author)
  • Pedersen, Alma B.Aarhus Univ Hosp, Dept Clin Epidemiol, Aarhus, Denmark.;Aarhus Univ, Dept Clin Med, Aarhus, Denmark. Univ Leeds, Leeds Inst Cardiovasc & Metab Med, Leeds, England. Univ Leeds, Leeds Inst Data analyt, Leeds, England. Leeds Teaching Hosp NHS Trust, Dept Cardiol, Leeds, England. Univ Oxford, Botnar Res Ctr, Nuffield Dept Orthopaed Rheumatol & Musculoskeleta, Oxford, England (author)
  • Gale, Chris P. (author)
  • Smith, James A.Univ Oxford, Ctr Stat Med, Nuffield Dept Orthopaed, Rheumatol & Musculoskeletal Sci, Oxford, England. John Radcliffe Hosp, Natl Inst Hlth Res, Oxford Biomed Res Ctr, Oxford, England. Ctr Studi ANMCO, Via Alfonso Marmora, Florence, Italy. Uppsala Univ, Dept Med Sci, Uppsala, Sweden. Uppsala Univ, Clin Res Ctr, Uppsala, Sweden. Univ Hosp Wales, Dept Cardiol, Cardiff, England (author)
  • Maggioni, Aldo P. (author)
  • James, Stefan,1964-Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)stjam367 (author)
  • Fraser, Alan G. (author)
  • Nelissen, Rob G. H. H.Leiden Univ Med Ctr, Dept Orthopaed, Leiden, Netherlands (author)
  • Mheen, Perla J. Marang-van deLeiden Univ Med Ctr, Dept Biomed Data Sci & Med Decis Making, Leiden, Netherlands (author)
  • Leiden Univ Med Ctr, Dept Orthopaed, Leiden, Netherlands.;Leiden Univ Med Ctr, Dept Biomed Data Sci & Med Decis Making, Leiden, NetherlandsLeiden Univ Med Ctr, Dept Orthopaed, Leiden, Netherlands (creator_code:org_t)

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  • In:International Journal of Health Policy and Management: Kerman University of Medical Sciences12:1, s. 1-112322-5939

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