텍스트 네트워크 분석을 통한 환자중앙감시시스템의 사용적합성 평가를 위한 위해요인 분석 = Hazard Analysis for Usability Evaluation of Central Monitoring System through Text Network Analysis

다국어 초록 (Multilingual Abstract)

In this study, text network analysis was performed using PMS(Post-Marketing Surveillance) data collected from the FDA's MAUDE(Manufacturer and User Facility Device Experience) database to evaluate the usability of the central monitoring system. Based on the data reported from January 1, 2021 to June 30, 2023, keywords related to the central moni- toring system were extracted and visualized with a text network. By analyzing the eigenvector centrality of text network, we identified hazards and types of hazardous situations related to usability of the central monitoring system. Eigenvector centrali- ty was chosen because it is relatively more accurate than other centralities. In addition, we derived an appropriate use scenario to evaluate the usability of the central monitoring system. The research results provide more realistic and valuable insights through data derived based on actual adverse event cases, and are expected to contribute to improving safety and reliability by identifying user requirements for improved usability and reducing use errors in the future.

참고문헌 (Reference)

1 "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm"

2 "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=870"

3 정지용 ; 김유림 ; 장원석, "Summative Usability Assessment of Software for Ventilator Central Monitoring System" 44 (44): 363-376, 2023

4 Kumar N, "Ranking Plant Network Nodes Based on Their Centrality Measures" 25 (25): 676-, 2023

5 Garzotto F, "Preventing infectious diseases in Intensive Care Unit by medical devices remote control : Lessons from COVID-19" 61 : 119-124, 2021

6 Maqbool B, "Potential effectiveness and efficiency issues in usability evaluation within digital health : A systematic literature review" 208 : 111881-, 2024

7 Celardo L, "Network text analysis : A two-way classification approach" 51 : 102009-, 2020

8 Janyasupab P, "Network diffusion with centrality measures to identify disease-related genes" 18 (18): 2909-2929, 2021

9 Salah M, "May the force of text data analysis be with you : Unleashing the power of generative AI for social psychology research" 1 (1): 100006-, 2023

10 Miclaus T, "Impact of Design on Medical Device Safety" 54 (54): 839-849, 2020

11 Frost HR, "Identifying vital nodes in hypernetwork based on local centrality" 9 (9): 14-, 2023

12 Ishfaq U, "Identifying the influential nodes in complex social networks using centrality-based approach" 34 (34): 9376-9392, 2022

13 Chen D, "Identification of Influential Nodes in Complex Networks With Degree and Average Neighbor Degree" 13 (13): 734-742, 2023

14 ISO, "ISO 14971 : Medical devices – Application of risk management to medical devices" International Organization for Standardization 2019

15 Camilleri E, "Evaluating latent content within unstructured text : an analytical methodology based on a temporal network of associated topics" 8 (8): 124-, 2021

16 Tatro ES, "Device failures and patient-related adverse events associated with endoscopic variceal ligation devices a MAUDE database analysis" 2 (2): 319-323, 2023

17 Yan C, "Collaboration Structure in COVID-19 Critical Care : Retrospective Network Analysis Study" 8 (8): e25724-, 2021

18 Mokshal H. Porwal ; Devesh Kumar ; Sharadhi Thalner ; Hirad S. Hedayat ; Grant P. Sinson, "Analysis of reported adverse events of pipeline stents for intracranial aneurysms using the FDA MAUDE database" 25 (25): 275-, 2023

19 AnalystView Market Insights, "Analysis Market Insights. Patient Monitoring Devices Market with COVID-19 Impact Analysis, By Product, By Type, By End use, By Country, and By Region – Industry Analysis, Market Size, Market Share &Forecast from 2023-2030" 2023

20 Oner B, "A text mining and network analysis of topics and trends in major nursing research journals" 11 (11): e2050-, 2024

21 Poncette AS, "A Remote Patient-Monitoring System for Intensive Care Medicine : Mixed Methods Human-Centered Design and Usability Evaluation" 9 (9): e30655-, 2022