Scientific article
Review
OA Policy
English

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

Publication date2023
First online date2023-07-18
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
  • Humans
  • Orthopedics
  • Equipment Safety
  • Reproducibility of Results
  • Registries
Funding
  • European Commission - Coordinating Research and Evidence for Medical Devices [965246]
Citation (ISO format)
HOOGERVORST, Lotje A et al. 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. In: International journal of health policy and management, 2023, vol. 12, p. 7648. doi: 10.34172/ijhpm.2023.7648
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Article (Published version)
Identifiers
ISSN of the journal2322-5939
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Technical informations

Creation08/30/2023 9:01:27 AM
First validation03/26/2024 9:42:43 AM
Update time03/26/2024 9:42:43 AM
Status update03/26/2024 9:42:43 AM
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