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標題: | 臺灣重處理單次使用醫材現況初探 Reprocessing and Reuse of Single-Use Medical Devices in Taiwan: An Exploratory Study |
作者: | 廖儀幀 Yi-Zheng Liao |
指導教授: | 葉明叡 Ming-Jui Yeh |
關鍵字: | 重處理,單次使用,醫療器材,利害關係人分析,政策評估, reprocessing,single use,medical device,stakeholder analysis,policy evaluation, |
出版年 : | 2023 |
學位: | 碩士 |
摘要: | 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。 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. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/89520 |
DOI: | 10.6342/NTU202302106 |
全文授權: | 未授權 |
顯示於系所單位: | 健康政策與管理研究所 |
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