法學期刊
  • 社群分享
論著名稱:
細胞治療檢體及成品的儲存與運送(Storing and Transporting Cell Therapy Specimens and Products)
文獻引用
編著譯者: 黃瓊瑰薛宇珊
出版日期: 2022.05
刊登出處: 台灣/醫療品質雜誌第 16 卷 第 3 期/26-31 頁
頁  數: 6 點閱次數: 221
下載點數: 24 點 銷售明細: 權利金查詢 變更售價
授 權 者: 財團法人醫院評鑑暨醫療品質策進會 授權者指定不分配權利金給作者)
關 鍵 詞: 細胞治療特管辦法檢體運送細胞製品運送連續溫度紀錄
中文摘要: 細胞治療在國內的特管辦法施行後,陸續吸引了許多醫療院所引進相關的特定治療技術。為確保細胞治療的安全性,必須確保人體組織或血液檢體與細胞製品的儲存及運送過程全程低溫,且有連續的溫度監控。人體的組織或血液檢體與細胞製品必須有清楚且完整的效期及儲存條件的標示。若細胞製品發生損壞或運送過程中溫度未達要求,應進行細胞製品的銷毀。為確保病人接受細胞治療的安全性,執行細胞治療的醫院應設置異常事件的通報及處理流程,以避免對病人造成危害。
英文關鍵詞: cell therapyRegulations Governing the Application or Use of Specific Medical Techniques or Examinations or Medical Devicesspecimen transportationcell product transportationcontinuous temperature record
英文摘要: After the enaction of the Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices, many medical institutions have introduced medical techniques specific to cell therapy. To ensure the safety of cell therapy, human tissue or blood specimens and cell products must be stored and transported at low temperature throughout the entire process and continuously monitored for their temperature. The tissue, specimens, and products must have their expiration dates and storage conditions labeled clearly and completely. Cell products that are damaged or transported without meeting the temperature requirements must be destroyed. To prevent the potential hazards of cell therapy and thus ensure patient safety, medical institutions conducting cell therapy must establish procedures for reporting and handling adverse events.
目  次: 前言
檢體與細胞製品的保存方式
檢體與細胞製品的運送與接收
細胞製品的異常處理與銷毀
結語
相關法條:
相關判解:
相關函釋:
相關論著:
黃瓊瑰、薛宇珊,細胞治療檢體及成品的儲存與運送,醫療品質雜誌,第 16 卷 第 3 期,26-31 頁,2022年05月。
返回功能列