2018-01-012024-05-16https://scholars.lib.ntu.edu.tw/handle/123456789/666875摘要：藥物(包含藥品及醫療器材)持續進行上市後監視與安全評估為國際間重要議題，其目的係為了加強上市後醫療器材之安全監控，並了解中高風險醫療器材於國內實際使用之情形，進而針對其潛在之安全性風險擬定相關對應措施，以維護使用者安全。經上市後安全監控發現，不良反應通報案件多以心臟及血管類裝置(E大類)及一般及整型外科手術裝置(I大類)大類醫療器材為主，爰此，本計畫擬針對心臟及血管類裝置(E大類)或一般及整型外科手術裝置(I大類)醫療器材，選定至少一項國人常用之中高風險醫療器材，主要利用健保資料以流行病學方式進行評估，如該醫療器材之使用情形(如:使用量、適應症、治療型態…等)以及觀察使用後之預後(如:疑似不良事件…等)，以評估該醫療器材於我國之臨床使用情形及是否有新增之安全疑慮，進而依據評估結果研擬該醫療器材相關風險管理之應對措施，以提升民眾使用醫療器材之安全性。<br> Abstract: Post-marketing surveillance and safety assessment of medical products (including drugs and medical devices) is a major public health issue. In order to ensure the patient safety of medical device, it is important to routinely evaluate the usage pattern and detect manage safety signal surveillance of medical device. Since previous results from adverse events/products reporting system suggest that cardiovascular devices (E class) or general and plastic surgery devices (I class) were reported most frequently, this study aims to systematically evaluate the risk profiles of at least 1 device of medium-high risk in Taiwan. The Taiwan National Health Insurance data will be the primary data source in order to evaluate the utility of this data environment for safety assessment purpose. The analysis will be descriptive in nature, providing information on usage pattern of medical device and the demography characteristics or clinical outcomes among those who received the target medical devices. The main objective of this study is to assess the provisional results and ultimately provide concrete regulatory suggestions for post-marketing safety surveillance of medical devices in Taiwan.醫療器材上市後監視安全評估健保資料Medical Devicepost-marketing surveillancesafety assessmentNational Health Insurance Research Database (NHIRD)