跳到主要內容

臺灣博碩士論文加值系統

(3.236.28.137) 您好!臺灣時間:2021/07/25 21:21
字體大小: 字級放大   字級縮小   預設字形  
回查詢結果 :::

詳目顯示

我願授權國圖
: 
twitterline
研究生:李偉祥
研究生(外文):Wei-Shiang Lee
論文名稱:醫療器材安全管理法規與通報制度探討
論文名稱(外文):Medical Device Safety Regulation and Reporting System
指導教授:王惠玄王惠玄引用關係
學位類別:碩士
校院名稱:長庚大學
系所名稱:醫務管理學研究所
學門:商業及管理學門
學類:醫管學類
論文種類:學術論文
論文出版年:2005
畢業學年度:93
語文別:中文
論文頁數:120
中文關鍵詞:醫療器材安全管理規範病人安全通報系統
外文關鍵詞:Medical deviceSafety regulationsPatient safetyReporting system
相關次數:
  • 被引用被引用:3
  • 點閱點閱:581
  • 評分評分:
  • 下載下載:0
  • 收藏至我的研究室書目清單書目收藏:8
病人安全已是全球的問題,近年來國際間透過各種研究,試圖瞭解醫療錯誤的全貌,不論是從法律面,或從風險與管理面探討醫療錯誤,均已累積相當多的可貴研究資料;然而對於醫療照護與治療不可或缺的醫療器材與病人安全之相關探討,卻是非常有限。
本研究透過文獻整理與回顧,系統性探討分析,瞭解醫療器材安全管理法規、探討醫療器材錯誤原因與類型,和研議醫療器材,不良事件通報系統的建置要點。歸納研究結果: (1) 醫療器材安全屬性,並非完全可以依賴,上市前之審查機制,如醫療器材設計、製造與使用者操作錯誤等問題,均足以在核准上市後的使用過程發生與病人安全相關問題;透過醫療器材通報系統,可以提供具體實證,要求醫療器材製造商,改善去除上述之不安全因素。(2) 歐美醫療器材產業體系,早已不斷持續改善產品,因其產品生命週期,從設計研發、生產製造、上市前審查,與上市後監視,均有相當嚴謹之安全規範管制。這也說明,為何此波病人安全運動,似乎沒有特別注意到醫療器材與病人相關安全議題。(3) 我國醫療器材管理辦法,僅注重於上市前審查機制,對於醫療器材上市後監視機制,一付如闕。(4) 儘管我國實施醫療器材通報系統,採自願通報,但續兩年通報案件僅有個位數,明顯通報不足,且無監督考核機制。
研究建議為(1) 醫療器材安全管理政策,立即修改醫療器材管理辦法,納入上市後監視機制;對於現階段醫療器材不良通報不足,可積極加強對醫療機構教育宣導,醫療器材不良通報制度與主動定期發佈醫療器材警訊。(2) 醫療器材製造商,於醫療器材的生命週期,應徹底做好完善的產品責任風險管理。(3) 醫療器材經銷商除了銷售產品外,同時也負有教導使用者正確操作醫療器材責任;並建立醫療器材相關維護、保養紀錄,供使用者與製造商查詢參考。(4) 醫療器材使用者,應接受正確操作訓練與瞭解其構造及原理;並可善用使用者手冊或是檢查表等工具落實醫療器材之正確操作,避免造成病人因使用者錯誤而蒙受不必要傷害。

關鍵字: 醫療器材、安全管理規範、病人安全、通報系統。
Patient safety has become a global hot issue. Although leading researchers try to fully discover causes of medical errors from different perspectives, such as legal liability and risk management, and have accumulated valuable information, but for the modern healthcare system that relies increasingly on medical devices in treatment procedures, there are very limited study on medical devices-related patient safety issues.
This study, through systematic literature review, aims to understand medical devices safety regulations, clarify causes of medical devices-related errors and critical factors in building the medical device reporting system.
The findings include: (1) Approval of medical devices safety through regulations does not guarantee safety in use. Due to design errors, manufacturing errors and user errors, medical devices may induce patient safety issues. However, such devices-related errors can be detected through medical devices reporting system, and through appropriate analyses and researches, provide evidence to manufacturers in removing unsafe factors. (2) The medical devices industry in the U.S. or European countries, have well-established regulations for design control, validation, premarket approval and postmarket surveillance phases to closely monitor medical devices quality and safety. That is probably the reason why medical device-related patient safety issues rarely got notices in the patient movement wave. (3) Taiwan has limited its medical devices safety monitoring through GMP regulations, leaving medical devices postmarket surveillance at large. (4) The medical devices reporting in Taiwan is voluntary and obviously face under reporting issues.
The recommendations and suggestions are as follows: (1) policy maker should modify medical device regulations to include postmarket surveillance and medical device reporting. To promote reporting, it may enhance education to hospitals and issue medical device alert letter on regular and timely basis. (2) The medical device manufactures shall implement risk management for each medical device product cycle. (3) The medical device distributors bear the responsibility to conduct device user operation training, and file all device maintenance and service records. (4) The user shall receive proper operation training. Users are strongly advised to adopt reference manuals or check list techniques in properly operating the devises, less patients endure unnecessary harms.

Keywords: Medical device; Safety regulations; Patient safety; Reporting system.
目錄
指導教授推薦書 ……………………………………………………...
口試委員審定書 …………………………………………………..…
授權書 ………………………………………………………………….iii
致謝 ………………………………………………………………….iv
中文摘要 ………………………………………………………………v
英文摘要 …………………………………………………………….vii
目錄 …………………………………………..…………………….viii
圖目錄 …………………………………………………………………..xi
表目錄 ……………………………………………………………..xii
第一章 緒論 ………………………………………………………….1
1.1 研究背景與動機 ........…………………………………….…1
1.2 研究方法與目的 .………..…………….….…………………6
1.3 研究範圍與論文架構 ………….…………………………….7
1.4 預期貢獻 ……………………………………………………..9
1.5 名詞解釋 ……………………………………..………………9
第二章 醫療器材管理 ..……………………………………….....12
2.1 醫療器材產業特色 …...………….…..…………………..12
2.2 醫療器材定義 ……………………………………………….17
2.3 醫療器材分級管理規範 ………………………………….20
2.4 全球醫療器材法規調和興起 ……………………………..28
第三章 醫療器材相關錯誤 …………………….……………………..30
3.1 病人安全 ……………………………………………………30
3.2 醫療器材錯誤類型 …………….…………………………….33
3.2.1 設計錯誤 ……………………………………………….35
3.2.2 製造錯誤 ……………….………………………….39
3.2.3 使用者錯誤 …………………………………………...40
3.3 小結 ………..……………………………………………….43
第四章 醫療器材不良事件通報系統 ……………………………..45
4.1 美國醫療器材不良事件通報系統 ………………………...46
4.2 英國醫療器材不良事件通報系統 ……….………………..52
4.3 台灣醫療器材不良事件通報系統 ………………………...56
4.4 小結 ………………………………………………………...61
第五章 個案分析 ……………………………………………….63
5.1 嬰兒呼吸中止監視器電極導線防護 ……………………65
5.2 通報錯誤與改善措施 ………………………………………67
5.3 小結 ………………………………………………………...68
第六章 結論與建議 ……………………………………...………..70
6.1 研究結論 ……………………………………………………71
6.2 研究建議 ……………………………………………………73
6.3 研究限制 ……………………………………………………77
參考文獻 ……………………………………………………………..78
附錄1病人安全定義 ……………………………………………….86
附錄2台灣醫療器材管理辦法…..……………………………………88
附錄3台灣醫療器材優良製造規範 ……………………………..90
附錄4 FDA核准上市某醫療器材製造商品質系統文件 ………….101
附錄5醫療器材不良反應通報表 ……………………………118

圖目錄
圖1.1 研究流程 ……………………………………………………..8
圖2.1醫療器材產品生命週期管理 ………………………………….13
圖2.2 FDA醫療器材產品生命週期管制 ………………………...14
圖3.1醫療錯誤辨識架構 …………………………………………...32
圖3.2醫療器材相關的錯誤分類架構 ……………………………..34
圖3.3醫療器材設計人因工程標準HF74 ………………………...38
圖4.1台灣醫療器材不良通報反應中心作業流程 ……………….59
圖5.1具有保護插梢設計之安全電極導線 ………………………...64
圖5.2不安全之電極導線 …………………………………………...64
圖6.1台灣整合性病人安全政策架構 ……………………………..70
中文參考文獻
行政院衛生署,(1970),「藥物藥商管理法」,中華民國。
行政院衛生署,(1993),「藥事法」,中華民國。
行政院衛生署a,(2004),衛生署藥字第09328320號公告「本署受託查核機構與歐盟代施查核機構建立技術合作,簡化藥商申請醫療器材優良製造規範之文件」,中華民國。
行政院衛生署b,(2004),衛生署藥字第09328328號公告「醫療器材管理辦法」及「醫療器材查驗登記審查準則」,中華民國。
王明揚、王茂俊、蔡銘仁、傳鑫淩 (1993),「產業設備的人機介面對工業安全衛生的影響評估與改善對策」,勞工安全衛生研究季刊,1.1(2),頁29-38。
李子偉,(1997),「FDA進行再造工程以風險性為衡量基礎」, MD News醫療器材報導,07,頁10-12。
李明亮主編,(2004),全國衛生醫療政策會議總結報告書。台北:國家衛生研究院。
林威宇,(2002),「醫療器材產業報告」,台北:太平洋證劵,太平洋天財網。
林綺芬,(2003),「生醫人專訪:堅持專業認真學習專訪李子偉(量測中心醫療器材認證室主任)」, 經濟部工業局生醫知識網。World Wide Web:http://biomedical.itri.org.tw/news/newsDetail.aspx?no=57. Search on June 1st, 2005
厚生省,(2001),「第1回醫療安全對策檢討會議」,厚生省,日本。
潘彥妃,(2001),「衛生署一周前已回收」,聯合報11月4日,5版。
陳志宏,(2005),「要多安全才夠安全-從抽象到具體的實現」,生技與醫療器材報導月刊, 69,頁49-56。
趙蘭英主編,(2004),2004 醫療器材工業年鑒,台北:經濟部技術處。
謝博生,(2005),「醫策會未來的努力方向」,財團法人醫院評鑑暨醫療品質策進會簡訊,6 (1),頁2。

英文參考文獻
Aspden, P., Corrigan, J.M.,Wolcott, J., Erickson, S.M., (2003), Patient Safety Achieving a New Standard for Care , Washington, D.C.: Institute of Medicine, The National Academies Press.
Association for the Advance of Medical Instrumentation, (2001), “Human Factors Design Process for Medical Devices HE74”, American National Standard Institute.
Baxter International Inc., (2001), “Following Extensive Investigation, Baxter Identifies Probable Cause of Recent Hemodialysis Patient Deaths”.
Buckle, P., Clarkson, P.J., Coleman, R., Lane, R., (2003), Design for Patient Safety, London: Department of Health and The Design Council.
Burton, T.M., (2003), “Baxter Is Subpoenaed Over Dialyzer Deaths”. The Wall Street Journal , New York. March 13: D.3.
Carstensen, P., (2000). “IEC develop standard for medical device human factor design-ensuring a safe device-user interface”, Proceeding of the Human Factor and Ergonomics Society Meeting, 2-3 August 2002, San Diego, Santa Monica, CA: Human Factor and Ergonomics Society.
Chen, J.H., Kuo, A., Lee, W.S., (2005). “Issues of Device Safety in A Developing Country”, Proceeding of 27th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Shanghai.
Chief Medical Officer, (2000), “An organisation with a memory: Report of an expert group on learning from adverse events in the NHS”, London: The Stationery Office.
Daily, W., Klaus, M., Meyer, H.B., (1969). “Apnea in premature infants: monitoring, incidence, heart rate changes, and an effect of environmental temperature”, Pediatrics, 43: 510-518.
Emergence Care Research Institute, (1987), “Connection of Electrode Lead Wires to Line Power”, Health Devices, 16: 44-46.
The European Commission, (1993), Council Directive 93/68/EEC CE Mark, European Union. World Wide Web: http://europa.eu.int/comm/enterprise/electr_equipment/emc/directiv/amend93-68.htm, Search on May 5, 2005.
The European Commission, (1993), Medical Device Directive 93/42/EEC, European Union. World Wide Web: http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=31993L0042&model=guichett. Search on May 5, 2005.
Food and Drug Administration, (1976), “The Medical Device Amendment of 1976”, United State.
Food and Drug Administration, (1985), “Medical Device Reporting Database”, United State.
Food and Drug Administration, (1990), “The Safe Medical Device Act of 1990”, United State.
Food and Drug Administration, (1992), “The Medical Devices Amendments of 1992”, United State.
Food and Drug Administration, (1993), “Safety Alert”, FDA
Food and Drug Administrationa, (1997), “The Federal Food, Drug & Cosmetic Act of 1997”, United State.
Food and Drug Administrationb, (1997), “Federal Register”, 62: 25477-25498.
Food and Drug Administration, (2001), “Device Advise”, FDA.
Feigal, D.W.; Gardner, S.N.; McClellan, M., (2003), "Ensuring Safe and Effective Medical Devices." New England Journal of Medicine 348(3): 191-192.
Gardner, S., (1999), Designing a Medical Device Surveillance Network: Report to Congress, Marilyn Flack.
Henderson, J.A., (2005), “FDA to Allocate $3.4 Million to MedSun for FY 2006”, Center for Integration of Medicine and Innovative Technology Regulatory Affairs, March.
Joint Commission on Accreditation of Healthcare Organizations, (1998), “Sentinel events: approaches to error reduction and prevention”, Joint Commission of Journal Quality Improvement 24: 175-186.
Joint Commission on Accreditation of Healthcare Organizations, (2005), “2005 Patient Safety Goal”.
Katcher, M., Shapiro, M.M., (1987), “Severe burns and death associated with electronic monitors”, New England Journal of Medicine 317(1): 56.
Katcher, M., Shapiro, M.M., Guist, C., (1986), “Severe injury and death associated with home infant cardiorespiratory monitors”, Pediatrics 78(5): 775-779.
Kaye, R., Crowley, J., (2000), Guidance for Industry and FDA Premarket and Design Control Review, FDA.
Kohn, L.T., Corrigan, J.M., Donaldson M.S., (1999), To Err Is Human: Building a Safer Health System. Washington, D.C.: Institute of Medicine, National Academy Press.
Leape, L., (1994), “Error in Medicine”, JAMA, 272 (23): 1851-1857.
Leape, L., (2002), “Reporting of Adverse Events”, New England Journal of Medicine, 347(20): 1633-1638.
Lemons, J.A., (2003), “Apnea, Sudden Infant Death Syndrome and Home Monitoring”, Pediatrics, 111(4): 914-917.
Meadows, M., (2003), “MedWatch: Managing Risks at the FDA”, FDA Consumer Magazine, 37.
Medical Device Agency, (1999), “Device Bulletin: Adverse Incident Reports 1999”, London: Medical Device Agency.
Medical Device Agency, (2000), “Device Bulletin: Adverse Incident Reports 2000”, London: Medical Device Agency.
Medical Device Agency, (2000), “Equipped to care:The safe use of medical devices in the 21th century”, London: Medical Device Agent.
Medical Device Agency, (2001), “Device Bulletin: Adverse Incident Reports 2001”, London: Medical Device Agency.
Medical Device Agency, (2002), “Device Bulletin: Adverse Incident Reports 2002”, London: Medical Device Agency.
Medical Device Agency, (2003), “Device Bulletin: Adverse Incident Reports 2003”, London: Medical Device Agency.
Medical Device Agency, (2004), “Device Bulletin: Adverse Incident Reports 2004”, London: Medical Device Agency.
Quality Interagency Coordination Task Force, (2000), “Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact”, Report to President, United State.
Rados, C., (2003), “FDA Works to Reduce Preventable Medical Device Injuries”, FDA Consumer Magazine, 37.
Sawyer, D., (1996), “Do it By Design”, FDA.
United State Government Accountability Office, (1989), “Medical Devices: Underreporting of Problems Backlogged Systems and Weak Statutory Support”, (GAO/T-PEMD-90-3), Washington, DC.
United State Government Accountability Office, (1997), “Medical Device Reporting: Improvements Needed in FDA’s System for Monitoring Problems with Approval Devices”, (GAO/HEHS-97-21), Washington, DC.
Vicente, K.J., Kada-Bekhaled, K., Gillian, H., (2003), “Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability”, Canadian Journal of Anesthesia 50: 328-332.
Ward, J., Clarkson, P.J., (2004), “An analysis of medical device-related errors: prevalence and possible solutions”, Journal of Medical Engineering & Technology, 28(1): 2-21.
Watcher, R., (2004), “The End of the beginning: Patient Safety Five Year After To Err Is Human”, Health Affairs Web Exclusive,.23(Jul-Dec): 534-545.
World Health Organization, (2004), “World Alliance for Patient Safety: Forward Programme 2005”, World Wide Web: http://www.who.int/patientsafety/en/brochure_final.pdf, Search on May 5, 2005
QRCODE
 
 
 
 
 
                                                                                                                                                                                                                                                                                                                                                                                                               
第一頁 上一頁 下一頁 最後一頁 top