ArticleCureus2024
A Comprehensive Analysis of Class I Medical Device Recalls: Unveiling Patterns, Causes and Global Impacts.
Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
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
In the landscape of medical device regulation, Class I recalls serve as pivotal indicators of potential risks, necessitating comprehensive analysis to unveil underlying patterns and causal factors. This research offers a detailed examination of Class 1 recalls, focusing on the critical aspects of device classification, review panel involvement, and the geographic distribution of recalling companies. Utilizing a robust dataset spanning multiple jurisdictions and device categories, this study reveals recurring trends in recall occurrences, providing insights into the regulatory mechanisms governing device safety assessments. Furthermore, it investigates the role of review panels in evaluating device safety and effectiveness, shedding light on their significance in the recall process. Moreover, the analysis explores the countries of origin of companies initiating recalls, offering insights into the global impact of regulatory actions on medical device manufacturers. By understanding the drivers behind recall decisions and their implications on a regional scale, regulatory authorities, and healthcare stakeholders can implement targeted measures to enhance patient safety and strengthen post-market surveillance practices.
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What OpenQuestion holds
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.