醫院用及市售環氧乙烯滅菌紗布及棉花無菌性調查   全文下載

The Sterility Survey of Ethylene Oxide Sterilized Gauzes and Cotton in Taiwan

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。有鑑於本局八十五年度之調查報告發現其中不合格者皆是以環氧乙烯滅菌，本計畫乃著重於篩檢以環氧乙烯進行滅菌之紗布及棉花之無茵狀況，因此委託各縣市衛生局及北、高兩市政府衛生局於民國八十八年九月至十二月間，至轄區內醫院、藥局及醫療器材行抽取以環氣乙烯進行滅菌之紗布及棉花檢品，抽樣範圍涵蓋五十家醫院、二十一家醫療器材行、五家藥局、兩家診所及一家衛生所，共計抽樣79件檢品，其中紗布38件而棉花41件，皆為國產製品。檢品經直接接種法滅菌檢查，結果發現紗布不合格者10件（佔26.3%），棉花不合格者9件（佔22.0%）。對於不合格產品已由原送驗衛生局查明處辦。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，此報告期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，曾於八十九年四月七日發布新聞在案。

Sterilized gauzes and cotton are not only used in the hospital, 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 treated with ethylene oxide for sterilization. To further investigate the sterility quality of commercial ethylene oxide treated gauzes and cotton, 79 samples, including 38 gauze samples and 41 cotton samples, were randomly sampled from 50 hospitals, 21 medical instrument corporations, 5 pharmacies, 2 clinics and 1 health office during the periods between September 1999 and December 1999 in Taiwan. The sterility test was conducted according to the procedures of direct transfer method as described in the fourth edition of Chinese Pharmacopeia. Our results showed that 10 gauze samples (26.3%) and 9 cotton samples (22%) did not meet the requirements of the sterility test.