請用此 Handle URI 來引用此文件：
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/89520完整後設資料紀錄
| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 葉明叡 | zh_TW |
| dc.contributor.advisor | Ming-Jui Yeh | en |
| dc.contributor.author | 廖儀幀 | zh_TW |
| dc.contributor.author | Yi-Zheng Liao | en |
| dc.date.accessioned | 2023-09-08T16:08:57Z | - |
| dc.date.available | 2023-11-09 | - |
| dc.date.copyright | 2023-09-08 | - |
| dc.date.issued | 2023 | - |
| dc.date.submitted | 2023-07-27 | - |
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Operating room waste: disposable supply utilization in neurosurgical procedures. Journal of Neurosurgery JNS, 126(2), 620-625. https://doi.org/10.3171/2016.2.JNS152442 | - |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/89520 | - |
| dc.description.abstract | 背景：2019年新聞報導臺灣多家醫療院所重複使用單次醫材，涉及病人安全且隱含欺瞞疑慮而引起廣泛討論，2020年政府亦提出重處理單次醫材之管制政策，並於2024年進入正式期。單次醫材之重處理，在國際文獻中已有許多不良事件與不同層面影響之討論，涵蓋品質、環保、經濟成本、倫理及法律，各國亦有不同政策與脈絡。然時至今日臺灣該議題探討之文獻甚少，本研究為描述臺灣重處理單次醫材現況之實證研究，用以評估政策。方法：為深入瞭解臺灣該議題脈絡，本研究利用深度質性訪談方法，透過立意抽樣17位利害關係人，包含食藥署、醫改會、醫療人員、醫院管理人員、醫材廠商，以了解現況、利害關係人互動、政策觀點、立場與建議。結果：研究發現臺灣廣泛存在重處理單次醫材，且涵蓋自費與非自費項目，重處理存在困境且導致之醫療失誤事件多未受到正視。各利害關係人對政策態度與認知差異甚大，如醫病間普遍存在資訊不對稱、醫療人員多未接受相關教育訓練或政策知識。現況與政策之間存在落差，如稽查效果有限、無重處理廠商之角色、醫療機構面對在即的政策正式期無相應之計畫。結論：本研究提出臺灣重處理單次醫材之政策分析、利害關係人分析、倫理分析。呼籲中央主管機關有所積極作為以推動政策前進，如加強稽查、鼓勵廠商投入市場、檢視健保點數合理與否、加強政策知識傳遞與通報、掌握現存重處理單次醫材品項，並正視根本問題，方能有效評估與調整政策、避免醫療機構惡性競爭，與利害關係人相互理解、有效溝通，以期達成政策目的——安全性、效能性、經濟可負擔。 | zh_TW |
| dc.description.abstract | Background: In 2019, news reports raised concerns about the widespread reuse of single-use medical devices in Taiwan, highlighting patient safety issues and potential deception. In 2020, the government proposed regulatory policies to address the reprocessing of single-use medical devices, which will enter the formal implementation phase in 2024. The international literature extensively discusses adverse events and various aspects, including quality, environmental impact, costs, ethics, and legal considerations. However, there is a scarcity of research specifically examining this topic in Taiwan. This study aims to provide an empirical examination of the current status in Taiwan and evaluate the effectiveness of the related policies. Methods: To gain an in-depth understanding of the context of this issue in Taiwan, this study utilizes a qualitative research approach, specifically conducting in-depth interviews with 17 stakeholders selected through purposive sampling. The interviews aimed to explore the current situation, stakeholder interactions, policy perspectives, positions, and recommendations. Results: Reprocessing of single-use medical devices is extensively practiced in hospitals in Taiwan. The practice of reprocessing presents challenges and leads to some near-miss events that often go unaddressed. Stakeholders exhibit significant differences in attitudes and perceptions towards the policies, such as information asymmetry between doctors and patients and a lack of relevant education and training among healthcare professionals. There is a discrepancy between the current situation and policy regulations, including limited inspection effectiveness, the absence of designated reprocessing facilities, and inadequate preparedness by healthcare institutions for the forthcoming policy period. Conclusion: This study provides policy analysis, stakeholder analysis, and ethical analysis. It calls for proactive actions to advance the policies, such as strengthening inspections, incentivizing manufacturer participation in the market, reviewing the appropriateness of national health insurance reimbursement, strengthening the dissemination of policy knowledge ,ensuring the implementation of reporting, gaining a comprehensive understanding of the existing reprocessed single-use medical device items, and addressing fundamental issues are essential for effectively evaluating and adjusting policies, as well as preventing malicious competition among healthcare institutions. Mutual understanding and effective communication with stakeholders are crucial to achieving the policy objectives of safety, efficacy, and economic feasibility. | en |
| dc.description.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2023-09-08T16:08:57Z No. of bitstreams: 0 | en |
| dc.description.provenance | Made available in DSpace on 2023-09-08T16:08:57Z (GMT). No. of bitstreams: 0 | en |
| dc.description.tableofcontents | 致謝i
中文摘要ii Abstractiii 目 錄v 圖目錄vii 表目錄viii 第一章 緒論1 第一節 研究背景1 一.單次醫材重處理的影響與潛在問題5 二.國際單次醫材重處理規範概述5 三.臺灣單次醫材重處理政策發展6 第二節 知識缺口與研究問題9 第三節 研究目的10 第四節 研究重要性10 第二章 文獻探討12 第一節 品質與安全12 第二節 環境保護16 第三節 經濟成本19 第四節 倫理層面議題20 第五節 法律層面議題22 第六節 各國規範與脈絡23 一.美國24 二.日本27 三.澳洲28 四.加拿大29 五.歐盟32 六.其他國家36 第七節 小結36 第三章 研究方法38 第一節 研究設計38 第二節 研究對象40 第三節 訪談重點45 第四節 分析方法45 第五節 研究限制46 第六節 研究倫理47 第四章 研究結果48 第一節 現況與事實50 一.重處理單次醫材項目與緣由50 二.單次醫材重處理過程與困境60 三.重處理單次醫材管理機制63 第二節 利害關係人互動66 一.揭露情形67 二.醫療失誤與不良事件75 三.決定權與責任歸屬77 第三節 政策建議與觀點82 一.醫療人員83 二.醫療機構管理人員91 三.醫材廠商95 四.財團法人台灣醫療改革基金會97 五.衛生福利部食品藥物管理署99 第四節 小結100 第五章 討論與建議102 第一節 綜觀全局：利益之爭102 第二節 政策分析103 一.議題設定與政策形成103 二.利害關係人分析106 三.預期影響110 第三節 公衛倫理分析112 第四節 政策建議114 第五節 未來研究建議116 第六章 參考文獻118 附錄一、訪談大綱131 附錄二、過渡期醫事司重處理單次醫材核准表133 圖目錄 圖 1 臺灣重處理單次使用醫材分階段漸進式管理政策9 圖 2 加拿大各省份重處理單次醫材政策31 圖 3 歐盟各會員國重處理單次醫材政策34 圖 4 研究流程圖40 表目錄 表 1 各國重處理單次醫材政策脈絡簡表35 表 2 臺灣重處理單次醫材利害關係人初步分析表41 表 3 受訪者基本資訊表格44 表 4 主題分析架構表49 表 5 臺灣重處理單次醫材品項一覽表58 表 6 臺灣重處理單次醫材利害關係人完整分析表109 表 7 現行政策框架下的可能情況112 | - |
| dc.language.iso | zh_TW | - |
| dc.subject | 重處理 | zh_TW |
| dc.subject | 醫療器材 | zh_TW |
| dc.subject | 單次使用 | zh_TW |
| dc.subject | 利害關係人分析 | zh_TW |
| dc.subject | 政策評估 | zh_TW |
| dc.subject | single use | en |
| dc.subject | medical device | en |
| dc.subject | stakeholder analysis | en |
| dc.subject | reprocessing | en |
| dc.subject | policy evaluation | en |
| dc.title | 臺灣重處理單次使用醫材現況初探 | zh_TW |
| dc.title | Reprocessing and Reuse of Single-Use Medical Devices in Taiwan: An Exploratory Study | en |
| dc.type | Thesis | - |
| dc.date.schoolyear | 111-2 | - |
| dc.description.degree | 碩士 | - |
| dc.contributor.oralexamcommittee | 林欣柔;郭年真;陳世英 | zh_TW |
| dc.contributor.oralexamcommittee | Shin-Rou Lin;Nien-Chen Kuo;Shey-Ying Chen | en |
| dc.subject.keyword | 重處理,單次使用,醫療器材,利害關係人分析,政策評估, | zh_TW |
| dc.subject.keyword | reprocessing,single use,medical device,stakeholder analysis,policy evaluation, | en |
| dc.relation.page | 161 | - |
| dc.identifier.doi | 10.6342/NTU202302106 | - |
| dc.rights.note | 未授權 | - |
| dc.date.accepted | 2023-07-27 | - |
| dc.contributor.author-college | 公共衛生學院 | - |
| dc.contributor.author-dept | 健康政策與管理研究所 | - |
| 顯示於系所單位： | 健康政策與管理研究所 | |
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