ArticleTherapeutic innovation & regulatory science2023
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices' Post-Market Surveillance.
Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- A five-phase evaluation framework for diagnostic and predictive medical artificial intelligence.NPJ digital medicine · 2026Article
- Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices.JAMA network open · 2026Article
- Clinical significance of field safety notices concerning implantable pacemakers and defibrillators.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Unveiling insights from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) portal.Scientific data · 2024Article
- Leveraging natural language processing to aggregate field safety notices of medical devices across the EU.NPJ digital medicine · 2024Article
- Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.Acta orthopaedica · 2024Article
- Limitations of NHIC claim code-based surveillance and the necessity of UDI implementation in Korea.Scientific reports · 2024Article
- Digital health interventions use cases: Classification and taxonomy development, a scoping review.Digital healthArticle
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4 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionThe EU Medical Device Regulation 2017/745 defines new rules for the certification and post-market surveillance of medical devices (MD), including an additional review by Expert Panels of clinical evaluation data for high-risk MD if reports and alerts suggest possibly associated increased risks. Within the EU-funded CORE-MD project, our aim was to develop a tool to support such process in which web-accessible safety notices (SN) are automatically retrieved and aggregated based on their specific MD categories and the European Medical Device Nomenclature (EMDN) classification by applying an Entity Resolution (ER) approach to enrich data integrating different sources. The performance of such approach was tested through a pilot study on the Italian data.
methodsInformation relevant to 7622 SN from 2009 to 2021 was retrieved from the Italian Ministry of Health website by Web scraping. For incomplete EMDN data (68%), the MD best match was searched within a list of about 1.5 M MD on the Italian market, using Natural Language Processing techniques and pairwise ER. The performance of this approach was tested on the 2440 SN (32%) already provided with the EMDN code as reference standard.
resultsThe implemented ER method was able to correctly assign the correct manufacturer to the MD in each SN in 99% of the cases. Moreover, the correct EMDN code at level 1 was assigned in 2382 SN (97.62%), at level 2 in 2366 SN (96.97%) and at level 3 in 2329 SN (95.45%).
conclusionThe proposed approach was able to cope with the incompleteness of the publicly available data in the SN. In this way, grouping of SN relevant to a specific MD category/group/type could be used as possible sentinel for increased rates in reported serious incidents in high-risk MD.
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