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研究生： 紀玫瑰
Dewi - Hardiningtyas
論文名稱： In-Depth Analysis of Medical Device Recall
In-Depth Analysis of Medical Device Recall
指導教授： 紀佳芬
Chia-Fen Chi
口試委員: 許總欣
Tsung-Shin Hsu
林廷宜
Tingyi S. Lin
學位類別： 碩士
Master
系所名稱： 管理學院 - 工業管理系
Department of Industrial Management
論文出版年： 2011
畢業學年度： 99
語文別： 英文
論文頁數： 92
外文關鍵詞： Medical device recall, in-depth investigation
相關次數： 點閱：224  下載：1 
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    • This study analyzed 363 medical device recalls filed in 2010-2011. These medical device recalls were extracted from the monthly publications of the United States Food and Drug Administrations (US FDA). Each of the medical device recall was analyzed in terms of device type, cause of recall, and severity level. Approximately 31.4% (114 cases) of medical device recalls belonged to General and Plastics Surgery Devices. Significant association between device type and cause of recall indicated that mechanical defect had caused majority of recall in General and Plastics Surgery Devices (109 cases, 30%). These analytical findings provide a direction for conducting in-depth adverse events investigation. Thus not only engineering area (safety science) but also the hospital itself and medical researcher can use this study to derive new perspective or potential study to reduce the number of medical device problem.

    CHAPTER I 1 INTRODUCTION 1 1.1 Background 1 1.2 Statement of the Problem 7 1.3 Objectives of the Study 7 1.4 Significance of the Study 8 1.5 Limitations of the Study 8 1.6 Organization of the Study 9 CHAPTER II 11 LITERATURE REVIEW 11 2.1 Medical Device Recall 11 2.1.1 Overview of Medical Device 11 2.1.2 Medical Device Recall Regulation 13 2.1.3 Medical Device Problem 15 2.1.4 Recalls Data 16 2.2 Taxonomy in Previous Medical Device Research 19 2.3 Statistical Analysis 22 2.3.1 Descriptive versus Inferential Statistics 22 2.3.2 Parametric versus Non parametric inferential statistical tests 22 2.3.3 Inferential statistical tests employed with two independent samples (nominal data) 23 2.3.3.1 The Chi-Square Test for Homogeneity 23 2.3.3.2 The Fisher Exact Test 25 2.3.4 Measures of Correlation/ Association (nominal data) 29 2.3.4.1 The Phi Coefficient 29 2.3.4.2 Cramer’s Phi Coefficient 30 CHAPTER III 33 RESEARCH METHODOLOGY 33 3.2 Classification Phase 35 3.3 Statistical Analysis Phase 35 3.4 Evaluation Phase 35 CHAPTER IV 36 MODEL DEVELOPMENT 36 CHAPTER V 38 RESULTS AND DISCUSSION 38 5.1 Medical Device Recall Classification Scheme 38 5.1.1 Source of Injury 38 5.1.2 Cause of Recall 39 5.1.3 Severity Level 41 5.2 Frequency distribution of variables 41 5.3 Association among contributing factors 44 5.3.1 Association between cause of recall and device type 45 5.3.2 Association between device type and severity level 47 5.3.3 Association between cause of recall and severity level 48 CHAPTER VII 52 CONCLUSIONS 52 REFERENCES 53 APPENDIX 56

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