2016-01-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/701365摘要：藥物(包含藥品及醫療器材)的上市後安全監視與評估為國際間相當熱門且持續關注之重要議題，各國發展均積極建立安全監視機制，期能及早發現藥物之風險疑慮並及時採取當的風險管控措施，如建立醫療器材不良反應/不良品通報系統、監測國際間有關醫療器材之安全警訊等。為多方控管醫療器材之使用安全，近年來國際間持續發展安全監測與評估機制，然而，目前國際間以大型健康醫療資料庫進行醫療器材安全評估之研究與文獻仍十分有限，鑑於醫療器材使用之風險疑慮於各國之間未必相同，故建立本土性醫療器材安全評估資料與機制有其必要。爰此，本計畫屬先導性研究計畫，擬依下列方式針對眼科及骨科中高風險醫療器材進行臨床效益與風險評估: (一) 建立我國醫療器材之風險疑慮名單，並評估該等醫療器材於我國之風險概況；(二)針對優先評估之研究標的，以我國健康保險資料庫進行流行病學研究，評估其上市後於我國之臨床效益與風險概況；(三)藉由本研究模式之經驗，如以健保資料庫之可行性…等，作為我國醫療器材風險疑慮評估機制建立之基礎，提供主管機關作為風險管控機制與政策擬訂之參考。<br> Abstract: Post-marketing surveillance and safety assessment of medical products (including drugs and medical devices) is a major public health challenge. Public health agencies across the world have developed a range of medical device safety surveillance systems, including the adverse evets/products reporting system. Safety alerts related by regulatory authority are routinely circulated around the world. In order to detect and manage safety signal in a comprehensive valid manner, different methods and data sources for safety signal detection and assessment are needed. As the large electronic healthcare databases have been widely utilized for safety assessment purpose, more empirical data related to safety issue of medical devices derived from health insurance claims database are needed. For this proposed pilot study, we aim to systematically evaluate the risk profiles of Ophthalmology and Orthopedics devices that are considered to be 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 the demography characteristics, comorbidity, and incidence of adverse events among those who received the target medical devices. The main objective of this pilot study is to evaluate a potential active surveillance model, assess the provisional results and learn from the experience through the pilot period, ultimately providing concrete regulatory suggestions for post-marketing safety surveillance of medical devices in Taiwan.醫療器材上市後安全監視安全評估健康資料庫