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
نویسندگان
1 Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
2 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
3 Department of Cardiology, Uppsala University, Uppsala, Sweden
4 Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy
5 Scientific Secretariat of the Presidency, Istituto Superiore di Sanità, Rome, Italy
6 Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium
7 Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
8 Botnar Research Centre and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
9 Department of Biomedical Data Sciences & Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands
10 Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
11 Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland
12 Directorate of Research Policy (Formerly: Walaeus Library), Leiden University Medical Center, Leiden, The Netherlands
13 Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
14 Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
15 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK
16 Leeds Institute for Data analytics, University of Leeds, Leeds, UK
doi
10.34172/ijhpm.2023.7648چکیده
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.
