查詢結果分析
來源資料
頁籤選單縮合
題 名 | 市售外科敷料、縫合針及縫合線(附針/不附針)之無菌性調查=The Sterility Survey of Surgical Dressing, Suture Needle and Suture (with Needle/without Needle) in Taiwan |
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作 者 | 連淑華; 莊珮君; 邱進益; 陳作琳; 林嘉伯; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 23 民94.09 |
頁 次 | 頁14-27 |
分類號 | 410.025 |
關鍵詞 | 外科用敷料; 縫合針; 縫合線; 無菌試驗; Sterility test; Dressing; Suture needle; Suture; |
語 文 | 中文(Chinese) |
中文摘要 | 外科敷料係指經滅菌並可能直接接觸傷口之敷料產品,包含手術 及外科用之含藥紗布、敷材等,而縫合針及縫合線則為手術用,此產品與人體組織、傷口直接接觸,若因滅菌不完全或運送、保存不當以致遭受微生物污染,則對於醫療品質影響甚鉅。本計畫係以源頭取樣為基本原則,委託各地衛生局直接至代理商、製造廠進行抽樣,調查其所販售外科用敷料(含外科敷材、止血膠棉、含藥紗布)、縫合針及縫合線等外科用耗材產品,是否有微生物污染情形,預計抽樣總件數為80 件,可用檢體數為43 件,其中國產檢體4 件佔9.3%,輸入檢體39 件佔90.7%。無菌試驗方法依美國藥典第27 版及中華藥典第五版之規定採濾膜法進行檢測,其結果顯示無菌性均符合藥典規定。本計畫以源頭抽取檢體之不合格率偏低,是否真正反映了市售品質之無菌性現況,尚未確定,未來抽樣程序應以市售品抽樣為優先,以能真實反映其市售品之無菌性狀況。本調查係本局之比較檢驗曾於九十三年八月三十一日發布新聞在案。 |
英文摘要 | Surgical dressing means dressing product that has been sterilized and possible direct contact with wounds, these products included surgical drug of gauzed and dressing, other product that is contact with human tissues and wounds, included surgical used suture needle and suture. If these product were sterilized, transport or preserve improbably and were infected by microorganism, it is a huge infect to medical quality. The purpose of these project is to survey quality of these product from the origin source. Total of 43 products were collected by the local health authority. Four (9.3%) of these samples were produced by local manufactures and the others (90.7%) were imported. The sterility test was conducted according to the procedures of membrane filtration method as described in US Pharmacopoeia XXVII and Chinese Pharmacopoeia V. The results show that all of the samples were qualified. Because of the high qualification rate in this survey, it is suggested that the survey of the products origin does really represents the quality sold in the market, so more market product survey must be done in the future to really represent the quality sold in the market. |
本系統中英文摘要資訊取自各篇刊載內容。