- 期刊
醫院用及市售環氧乙烷滅菌紗布及棉花無菌性調查
The Sterility Survey of Ethylene Oxide Sterilized Gauzes and Cotton in Taiwan
摘要
滅菌紗布及棉花不僅用於醫院之手術、消毒、止血或包紮，一般消費大眾也可自行在藥局及醫療器材行購買，用於傷口簡單消毒或包紮。因此，滅菌紗布及棉花廣泛地為消費大眾所使用。但若因滅菌不完全或運送、保存不當以致遭受微生物污染，則對於上述醫療品質影響甚鉅。 由本局85年度之調查報告發現其中不合格者皆是以環氧乙烷滅菌，故於89年度針對環氧乙烷滅菌之紗布及棉花製品委託台灣各地衛生局、所抽樣，進行無菌試驗（滅菌檢查），結果顯示不合格率合計高達24.1%。 有鑑於此，本於為民服務暨監督品質的責任，於本年度持續追蹤以環氧乙烷進行滅菌之紗布及棉花之無菌狀況，因此於民國90年4月至6月間，針對醫院、藥局及醫療器材行使用及販售之環氧乙烷滅菌之紗布及棉花製品，依據中華藥典第四版及美國藥典第24版，以直接法進行無菌試驗；抽樣範圍涵蓋21家醫院、12家醫療器材行、11家藥局、6家醫療器材公司及1家捐血中心，共計72件檢品，其中紗布37件，棉花35件，皆為國產製品。檢品以直接接種法進行無菌試驗，結果發現紗布不合格者1件（佔2.7%），棉花不合格者6件（佔17.1%），二者合計不合格率9.7%，較89年度大幅減少14.4%。 對於不合格產品已函知原送驗衛生局查明依藥事法處辦。雖然市售醫療用紗布及棉花是屬於無須向衛生署辦理查驗登記之醫療器材，惟仍應符合藥事法之相關規定，此報告不僅能提供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。本調查係本局之比較檢驗， 曾於九十年九月二十五日發布新聞在案。
並列摘要
Sterilized gauzes and cotton are not only used in the hospitals, but also at home. They might cause infection if they are not sterilized completely. According to the result of the survey done by NLFD in 1996, all of the unqualified gauzes and cotton were sterilized by ethylene oxide. Further, we conducted an investigation in 2000 on the gauzes and cotton sterilized by ethylene oxide. There was 24.1 % of samples that were not qualified. In order to understand the quality of ethylene oxide sterilized gauzes, 72 samples (37 gauze samples and 35 cotton samples) were randomly sampled from 21 hospitals, 12 medical instrument corporations, 11 pharmacies, 6 companies and 1 blood bank in Taiwan during April and June of 2001. The sterility test was conducted according to the procedures of direct transfer method as described in the fourth edition of Chinese Pharmacopiea and USP 24 edition. Our results showed that 1 gauze sample (2.7 %) and 6 cotton samples (17.1 %) of the 72 samples did not meet the requirment of the sterility test in this study; 9.7 % of the samples were not qualified. The sterility quality of commercial gauzes and cotton sterilized by ethylene oxide in 2001 was improved significant to compare with the result of 2000.
延伸閱讀
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