頁籤選單縮合
題 名 | 100年度醫療院所滅菌紗布、棉花及外科用敷料之無菌性監測=The Sterility Survey of Sterilized Gauzes, Cotton and Surgical Dressing in Taiwan |
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作 者 | 葉美伶; 許鳳麟; 王坤謄; 許家銓; 王德原; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 3 2012.11[民101.11] |
頁 次 | 頁307-311 |
分類號 | 419.38 |
關鍵詞 | 紗布; 棉花; 無菌透明敷料; 無菌試驗; Gauze; Cotton; Surgical dressing; Sterility test; |
語 文 | 中文(Chinese) |
中文摘要 | 滅菌紗布及棉花是一般民眾居家護理常用的醫療器材,在藥局及醫療器材行即可購得,它更常被使用於醫療院所之手術、消毒、止血或包紮,但若因滅菌不完全或運送、保存不當以致遭受微生物污染,使消費大眾增加感染機會,甚至有危害生命之虞。本計畫係以全國各醫療院所及藥局取樣為原則,委託各地衛生局抽樣,並依據中華藥典第六版及美國藥典第32版,以直接法進行無菌試驗,抽樣範圍涵蓋25家醫院、2家藥局,共計46件檢品,其中紗布30件,棉花11件,無菌透明敷料5件。依產地分類:國產19件(41.3%),大陸輸入22件(47.8%),其他國家輸入4件(10.9%)。檢品以直接接種法進行無菌試驗,結果顯示無菌性均符合藥典規定,惟有7件檢品,5張許可證(2張許可證重複)之外包裝標示與本署許可證查詢網記載不符(皆為大陸輸入之許可證),其中紗布6件,無菌透明敷料1件。對於不符檢品已函知原送驗衛生局查明並依藥事法處辦。本報告不僅能提供各醫療院所及相關衛生主管機關了解此類產品之現況,並提醒廠商加強產品之品質管制,以提升產品品質,俾對國人健康有所保障。 |
英文摘要 | Sterilized gauzes, cotton and surgical dressing are not only used in the hospitals, but also at home. They might cause infection if they are not sterilized completely. In order to understand the quality of sterilized gauzes, cotton and surgical dressing, 46 samples (30 gauze samples, 11 cotton samples, 5 surgical dressing) were randomly sampled from 25 hospitals and 2 pharmacies in Taiwan from March and June of 2012. Nineteen (41.3%) of these samples were produced by local manufactures, 22 (47.8%) of these samples were made in China and the other 5 samples (10.9%) were imported from other countries. The sterility test was conducted according to the procedures of direct transfer method as described in the sixth edition of Chinese Pharmacopoeia and USP 32 edition. The results showed that all of the samples were qualified for the sterility test but there are 7 samples (6 gauze samples, 1 surgical dressing) did not meet the labeling requirement by Pharmaceutical Affairs Act. This report not only provided the current status of the relevant products to the medical institutes and the relevant health authorities, but also strongly suggested the manufactures to strengthen the quality control of their products for the public health concern. |
本系統中英文摘要資訊取自各篇刊載內容。