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研究生:蘇明綢
研究生(外文):Ming-Chour Su
論文名稱:醫療器材風險評估與管理之初步研究
論文名稱(外文):The Preliminary Study of medical Device Risk Evaluation and Management
指導教授:蘇振隆蘇振隆引用關係
指導教授(外文):Jenn-Lung Su
學位類別:碩士
校院名稱:中原大學
系所名稱:醫學工程研究所
學門:生命科學學門
學類:生物化學學類
論文種類:學術論文
論文出版年:2006
畢業學年度:94
語文別:中文
論文頁數:138
中文關鍵詞:查驗登記審查醫療器材標準醫療器材指令優良製造規範風險評估與管理
外文關鍵詞:Inspection Registration and InvestigationMedical Device StandardMedical Device Directive(MDD)Risk Evaluation and ManagementGood Manufacturing Practice(GMP)
相關次數:
  • 被引用被引用:13
  • 點閱點閱:773
  • 評分評分:
  • 下載下載:14
  • 收藏至我的研究室書目清單書目收藏:5
為確保醫療器材產品品質符合世界趨勢、提升醫療臨床服務品質及保障人類健康,全球各國對醫療器材產品都進行全面的控管與審核,並將「風險評估與管理」導入醫療器材之管理,以研擬各類醫療器材查驗品項審查基準,作為上市前審查及上市後抽驗之依據。醫療器材管理之國際化是無法避免的,故本研究主要是研究如何將上述之觀念,針對國內之需求而導入現有規範進行初步之評估與探討。
本研究透過問卷調查國內醫療器材管理制度執行現況,其中醫療院所從業人員對現行醫療器材管理制度熟悉情形:「很熟悉」及「熟悉」合計28.4%、「普通」為41.8%、「不熟悉」及「未了解」合計29.8%;製造或代理廠商對現行醫療器材管理制度熟悉情形:「很熟悉」及「熟悉」合計15.6%、「普通」為33.3%、「不熟悉」及「未了解」合計51.1%,45份問卷中已建立不良醫療器材通報系統者19位(42.2%)。本研究並以風險矩陣分數值,評估國內醫療院所常用之43項醫療器材風險值,此外並針對美國ECRI網站近三年不良醫療器材通報及產品回收相關資訊,依據危害影響等級差異分別加權及彙整統計風險排序,並以臨床應用角度分別檢討國內外風險排序差異。
研究結果顯示醫療院所從業人員或廠商對醫療器材管理制度普遍不熟悉或未了解,而對不良醫療器材通報作業只有5位(11.1%)曾通報衛生署ADR中心顯示仍未落實ADR通報作業。就國內醫療院所常用之43項醫療器材,統計結果屬於高風險者計有呼吸器、麻醉機二項,屬於中度風險者有34項,屬於低風險者有7項;本研究並就屬於高風險醫療器材且排序第一之呼吸器,參酌國際ISO、美國、歐盟所制定之標準及美國FDA指引內容,完成其審查基準草案之研擬。
本研究已確認國內醫療院所常用醫療器材之風險等級,並完成呼吸器查驗品項審查基準,其結果可供醫療院所作為醫療器材維護管理與採購之參考、可供製造廠商作為生產製造風險管理之參考及作為政府未來上市前審查及上市後監督之重點品項參考。此外為落實國內醫療器材管理制度,本研究認為政府應推動醫工專業證照制度,衛生行政主管機關應加重醫療器材維護管理與品質安全監控之醫院評鑑分數比重並邀請醫工學者專家參與,廠商應建立定期器材追蹤制度及定期提報不良醫材通報作業,醫療院所應設置醫工人員負責醫療器材之維護管理與品質安全監控,才能有效確保醫療器材品質及安全,避免危害以保障國人健康。
In order to guarantee the quality of medical device and protect the human health, the global various countries all inducts "risk evaluation and management" into the management of the medical device, and draw up the inspection and investigation standard of each kind of medical device for pre-marketing investigation and post-marketing verification. Global harmonization of the medical device management is unavoidable, therefore this study according to the above idea, domestic requirement and the existing standard, to carry on the preliminary study of medical device risk evaluation and management.
This study investigates the performance current situations of the domestic medical device management system through the questionnaire. The familiar situation to the medical device management system for medical institute staffs are "very familiar" and " familiar" as 28.4%, "ordinary" as 41.8%, "unfamiliar" and "unknown" as 29.8%, for the manufacturer are "very familiar" and " familiar" as 15.6%, "ordinary" as 33.3%, "unfamiliar" and "unknown“ as 51.1%, and in 45 questionnaires there are 19(42.2%) have already built up the ADR system. A risk matrix method is used to evaluate the risk level for the 43 items medical device of the domestic medical institute commonly used. We also collected the American ECRI Health Devices Alerts issue for latest three years, and statistics the risk sequence based on “critical” and “high” risk influence rank with difference weighting, and discussed the difference risk sequence between domestic and foreign by the clinical application view.
The preliminary results show that most of the medical institute staffs and manufacturer were not familiar to the medical device management system, among them only 5 (11.1%) had ever notify to the Department of Health ADR center also show that the ADR system has not carry out well. The risk level of the domestic used medical device in which the ventilator and anesthesia machine two items belong to the high risk level, 34 items belong to the medium risk level and 7 items belong to the low risk level. We also deliberated the ISO, EU standards and FDA guideline to accomplish the standard for instrument with high risk level.
This study has already confirmed the risk level of the domestic used medical device, and accomplished inspection standard. The result may refer to the medical institute as the medical device maintenance management and the purchase reference, to the manufacturer as pre-marketing risk management reference, and to the government as pre-marketing investigation and post-marketing verification reference. In order to effectively guarantee the medical device quality and safety, avoids harming and ensure the people health, four suggestions were made in this study. There are 1.The government should impel the professional license system of biomedical engineering; 2.The Department of Health should increase the score proportion of the medical device maintenance management and the quality safety monitoring in hospital review system, and then invite the biomedical engineering professional to review the system; 3.The manufacturer should establish the medical device tracing system and reporting system regularly; 4.Tthe medical institute should set up the biomedical engineering personnel to be responsible for the maintenance management and quality monitoring of the medical device.
目 錄
摘 要 I
Abstract III
謝 誌 V
目 錄 VI
圖索引 VIII
表索引 IX
第一章 緒論 1
1-1 前言 1
1-2 研究背景 1
1-3 文獻回顧 3
1-4 研究目的 3
1-5論文架構 4
第二章 理論基礎 5
2-1 醫療器材管理 5
2-1-1 醫療器材分級與功能分類 5
2-1-1-1醫療器材一般分類方法 5
2-1-1-2 我國衛生署對醫療器材之分類 7
2-1-1-3 FDA對醫療器材之分類 8
2-1-1-4 歐盟對醫療器材之分類 9
2-1-2 醫療器材管理與法規 11
2-1-2-1我國之管理與法規 11
2-1-2-2 FDA對醫療器材之管理 13
2-1-2-3歐盟對醫療器材之管理 17
2-1-3 醫療器材標準 19
2-2 醫療器材產業 29
2-2-1 全球醫療器材產業 29
2-2-2 我國醫療器材產業 31
2-3 醫療器材風險評估 33
2-3-1 風險評估 34
2-3-2 國際之醫療器材風險管理的執行概況 40
2-3-3 FDA風險管理之相關規定 40
第三章 研究架構及方法 42
3-1 研究材料與設備 42
3-2 研究流程 42
3-3 研究方法 44
3-3-1 篩選彙總國內高風險度醫療器材之品項 44
3-3-2 蒐集彙整近三年不良醫療器材事件及產品回收之相關資訊 46
3-3-3 撰寫高風險度醫療器材審查基準 46
第四章 結果與討論 48

4-1 國內高風險醫療器材之調查與分析 48
4-2 不良醫療器材事件及產品回收之蒐集與彙整 66
4-3風險評估模式之建立 68
4-4高風險醫療器材審查基準草案之撰寫 72
4-5討論 72
4-5-1國內外高風險醫療器材討論 72
4-5-2國內醫療器材管理策略 75
第五章 結論與未來展望 83
5-1 結論 83
5-2 研究之貢獻 84
5-3 未來展望 85
參考文獻 87
附錄一、醫療器材風險評估與管理調查問卷 90
附錄二、問卷調查及訪問對象 99
附錄三、ECRI網站近三年不良醫療器材事件及產品回收統計明細表 105
附錄四、連續式呼吸器標準草案 113
作者自述 138

圖索引

圖一、研究流程圖 43



表索引

表一、醫療器材CE認證採用標準 22
表二、衛生署標準採認工作小組 24
表三、醫療器材採認標準 24
表四、2003年全球主要醫療器材市場規模 30
表五、2004年全球排名前十大醫療器材公司 31
表六、2004年我國主要醫療器材產品 32
表七、2004年我國前十大醫療器材公司 33
表八、風險矩陣 39
表九、問卷調查43項醫療器材品項 44
表十、問卷調查回收情況 48
表十一、前30名ECRI不良醫療器材事件及產品回收明細表 67
表十二、風險矩陣分數值統計表 70
表十三、43項醫療器材國內外風險排序 73
表十四、ADR通報系統統計 76
表十五、醫療器材風險原因排序 77
表十六、降低醫療器材風險方法排序 77
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