查詢結果分析
來源資料
頁籤選單縮合
題名 | 曾通報為不良品之滅菌紗布、棉花及醫院用/市售手術手套之無菌性調查=Sterility Survey of Surgical Gloves and Sterilized Gauze and Cotton That Were Previously Reported to Be Defective in Taiwan |
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作者 | 葉美伶; 林憶薰; 謝郁琦; 郭政佑; 楊依珍; 王德原; 施養志; Yeh, Mei-ling; Lin, Yi-hsun; Hsieh, Yu-chi; Kuo, Cheng-yeu; Yang, Yi-chen; Wang, Der-yuan; Shih, Yang-chih; |
期刊 | 食品藥物研究年報 |
出版日期 | 20131100 |
卷期 | 4 2013.11[民102.11] |
頁次 | 頁264-270 |
分類號 | 412.3 |
語文 | chi |
關鍵詞 | 紗布; 棉花; 手術手套; 無菌試驗; 環氧乙烷; E.O.; R-ray; Gauze; Cotton; Surgical glove; Sterility test; |
中文摘要 | 本計畫包含二類無菌醫療器材產品:一為不良品通報之無菌紗布、棉花及其他敷料,另一為手術手套,不良品通報產品委託源頭管轄衛生局進行製造廠或代理商所在地的源頭抽樣,手術手套則委託各縣市衛生局至各地方使用單位 (各縣市醫學中心、地區醫院及檢驗所)、藥房及藥局隨機抽樣,並依據中華藥典第七版 (1),以直接法進行無菌試驗。共抽得檢體94件,其中不良品通報產品之紗布 9件,棉花 7件,其他無菌敷料 3件,一般抽樣之手術手套 75件,試驗結果顯示不良品通報產品中紗布無菌性試驗 1件不合格 (11.1%),外觀不合格1件 (11.1%),棉花無菌性試驗 1件不合格 (14.3%),外觀不合格 1件(57.0%),其他敷料均合格,二者無菌性試驗不合格率為 10.5%,二者外觀不合格率為 26.3% (其中棉花製品有 1件同時為無菌及外觀不合格 )。一般抽樣之手術手套無菌性試驗 4件不合格 (5.3%),外觀 1件不合格(1.3%),總計不合格率為 6.7%。另調查中發現本次抽樣涵蓋之 38張許可證中,有 24張許可證之檢體外包裝標示與 TFDA許可證查詢網記載不符,包括品名之標示與許可證登記不符、未標示許可證字號或同一產品有 2個許可證字號等情形。以上不合格及不符合之情形皆已函覆所屬縣市衛生局執行缺失調查,並進行行政處分。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,保障國人健康。 |
英文摘要 | Two kinds of medical devices were covered in this study,namely sterilized gauze , cotton and dressing and surgical gloves . 19 samples (9 gauzes, 7 cottons, 3 surgical dressings) which have been reported previously as defective products, were collected by the local authority from factories and agents. 75 surgical gloves were randomly sampled from hospitals, pharmacies and drugstores in Taiwan. The sterility test was conducted according to the direct transfer method as described in the Chinese pharmacopeia 7th Edition. The results showed that 1 gauze sample (11.1%) and 1 cotton sample (14.3%) failed to meet the requirement of the sterility test, and1 gauze sample (11.1%) and 1 cotton sample (57.0%) failed to meet the requirement of the appearance test. All the dressing samples met the requirements . The percentage of non-compliance was 10.5%. 4 samples of surgical gloves (5.3%) failed to meet the requirement of the sterility test. 1 sample failed to meet the requirement of the appearance test (1.3%). The percentage of non-compliance was 6.7%. This report not only provides an insight to the current status of the relevant products to the medical institutions and health authorities, but also strongly suggests the manufacturers to strengthen the quality control of their products to protect public health. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。