ArticleThe Indian journal of medical research2025
Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data.
Article in The Indian journal of medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- National adverse event reporting for medical devices in Israel, 2013-2024.Israel journal of health policy research · 2026Article
- Nanomaterial-nucleic acid probe synergy: accelerating rapid pathogen detection and antimicrobial susceptibility testing in bloodstream infections.Folia microbiologica · 2026Review
- Nanotechnology in Dermatology: A Comprehensive Narrative Review of Performance, Safety, and Clinical Translation.Health science reports · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background & objectives To analyse post-market surveillance (PMS) trends for high-risk medical devices (Class IIb and III) in different geographic regions and evaluate the effectiveness of field safety corrective actions (FSCAs) in mitigating device-related risks. Methods This study utilised 2024 data from EUDAMED (European Database on Medical Devices), BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), and MAUDE (Manufacturer and User Facility Device Experience (FDA database)) to identify recurring incidents, associated device types, and the outcomes of FSCAs. A quantitative analysis was conducted to evaluate the frequency and severity of reported incidents, focusing on hardware failures, software malfunctions, and calibration issues. The impact of recalls, software updates, and field modifications on incident recurrence was also assessed. Results Orthopaedic implants, infusion pumps, and cardiac monitoring devices reported the highest number of incidents, primarily due to hardware failures and software issues. FSCAs involving hardware modifications significantly reduced recurrence rates, particularly for high-risk devices like pacemakers and ventilators. In contrast, software-driven devices exhibited persistent issues despite corrective actions, highlighting challenges in maintaining long-term reliability. Interpretation & conclusions The findings underscore the importance of robust PMS systems and tailored corrective actions in mitigating risks associated with high-risk medical devices. While FSCAs have demonstrated effectiveness in addressing hardware-related failures, enhancements in regulatory frameworks are necessary to improve the management of software-driven devices.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.