ArticleBMC health services research2022
Establishment of a medical device adverse event management system for hospitals.
Article in BMC health services research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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.
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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.
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Who cites it
5 citing papers in PubMed, 12 citations in OpenAlex.
- National adverse event reporting for medical devices in Israel, 2013-2024.Israel journal of health policy research · 2026Article
- Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study.JMIR medical informatics · 2026Article
- Challenges and dynamics in reporting medical device incidents: a qualitative study.Frontiers in health services · 2025Article
- Article
- Advancements in materiovigilance: A comprehensive overview.Perspectives in clinical researchReview
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundThe management of medical device adverse event (MDAE) is one of the most important aspects of improving medical quality and safety management. Nonetheless, hospitals still lack standardized and unified initiatives to improve MDAE management.
methodsThis study, thus, established a MDAE monitoring system on May 1 in 2011 for suspected adverse events and designed a hospital-based dynamic warning system, aiming to standardize the process of MDAE handling and provide real-time monitoring for MDAEs in a hospital. This system was used in the First Affiliated Hospital of Zhejiang University School of Medicine. Numbers and the compound growth rate of MDAE reports from 2010 to 2020 were compared to test the effectiveness of the MDAE monitoring system. Numbers of MDAE reported to the National Adverse Event Monitoring System were also compared over 2013 to 2020, due to the loss of data before 2013 after shutdown of the old system. Efficacy and usability of the hospital-based dynamic warning system was then verified by analyzing risk and warning levels of MDAEs in 2020. Descriptive statistics was used for data analysis in this study.
resultsResults showed that the compound annual growth rates of MDAE reports and those submitted to the National Adverse Event Monitoring System from 2013 to 2020 were 35.0% and 31.5%, respectively. A standardized management of MDAE with full participant, timely response and effective feedback was formed in the hospital by establishment of the MDAE system.
conclusionsThis system effectively improved the monitoring level of MDAEs, helping to improve early detection, early warning, and early intervention of risk of medical device. This study may provide suggestions for medical institutions to establish a MDAE monitoring system, and may promote development of medical quality and safety management for hospitals to some extent.
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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.