. 2023:12:7648.

doi: 10.34172/ijhpm.2023.7648. Epub 2023 Jul 18.

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

Lotje A Hoogervorst^{1

2}, Timon H Geurkink¹, Anne Lübbeke^{3

4}, Sergio Buccheri⁵, Jan W Schoones⁶, Marina Torre⁷, Paola Laricchiuta⁷, Paul Piscoi⁸, Alma B Pedersen^{9

10}, Chris P Gale^{11

12

13}, James A Smith^{14

15}, Aldo P Maggioni¹⁶, Stefan James^{5

17

18}, Alan G Fraser¹⁹, Rob G H H Nelissen¹, Perla J Marang-van de Mheen²

Affiliations

¹ Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands.
² Department of Biomedical Data Sciences & Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands.
³ Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
⁴ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁵ Department of Cardiology, Uppsala University, Uppsala, Sweden.
⁶ Directorate of Research Policy (Formerly: Walaeus Library), Leiden University Medical Center, Leiden, The Netherlands.
⁷ Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy.
⁸ Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium.
⁹ Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
¹⁰ Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
¹¹ Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
¹² Leeds Institute for Data analytics, University of Leeds, Leeds, UK.
¹³ Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹⁴ Botnar Research Centre and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
¹⁵ National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK.
¹⁶ Centro Studi ANMCO, Via Alfonso la Marmora, Florence, Italy.
¹⁷ Department of Medical Science, Uppsala University, Uppsala, Sweden.
¹⁸ Clinical Research Center, Uppsala University, Uppsala, Sweden.
¹⁹ Department of Cardiology, University Hospital of Wales, Cardiff, UK.

PMID: 37579359
PMCID: PMC10702370
DOI: 10.34172/ijhpm.2023.7648

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

Lotje A Hoogervorst et al. Int J Health Policy Manag. 2023.

. 2023:12:7648.

doi: 10.34172/ijhpm.2023.7648. Epub 2023 Jul 18.

Authors

Affiliations

¹ Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands.
² Department of Biomedical Data Sciences & Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands.
³ Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
⁴ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁵ Department of Cardiology, Uppsala University, Uppsala, Sweden.
⁶ Directorate of Research Policy (Formerly: Walaeus Library), Leiden University Medical Center, Leiden, The Netherlands.
⁷ Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy.
⁸ Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium.
⁹ Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
¹⁰ Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
¹¹ Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
¹² Leeds Institute for Data analytics, University of Leeds, Leeds, UK.
¹³ Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹⁴ Botnar Research Centre and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
¹⁵ National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK.
¹⁶ Centro Studi ANMCO, Via Alfonso la Marmora, Florence, Italy.
¹⁷ Department of Medical Science, Uppsala University, Uppsala, Sweden.
¹⁸ Clinical Research Center, Uppsala University, Uppsala, Sweden.
¹⁹ Department of Cardiology, University Hospital of Wales, Cardiff, UK.

PMID: 37579359
PMCID: PMC10702370
DOI: 10.34172/ijhpm.2023.7648

Abstract

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 Conformité Européenne (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.

Keywords: Cardiovascular; Medical Device Registries; Orthopaedic.

© 2023 The Author(s); Published by Kerman University of Medical Sciences This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Conflict of interest statement

Authors declare that they have no competing interests.

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References

1. International Medical Device Regulators Forum (IMDRF). Principles of International System of Registries Linked to Other Data Sources and Tools. September 30, 2016. https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imd....
1. AHRQ Methods for Effective Health Care. In: Gliklich RE, Leavy MB, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Rockville, MD: Agency for Healthcare Research and Quality; 2020. - PubMed
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1. Medical Device Coordination Group, European Commission. Regulation (EU) 2017/745: Clinical Evidence Needed for Medical Devices Previously CE Marked Under Directives 93/42/EEC or 90/385/EEC. A Guide for Manufacturers and Notified Bodies. 2020. https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2020_6_guidance....

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Research Materials