市售軟性隱形眼鏡之無菌性調查

The Sterility Survey on Soft Contact Lens in Taiwan Market

10.6946/ASRNL.200309.0086

賴秀芸(Show-Yun Lai)；洪忠志(Chung-Chih Hung)；陳作琳(Tso-Ling Chen)；陳惠芳(Hwei-Fang Cheng)；林嘉伯(Chia-Po Lin)

醫療器材分類分級 ； GMP規範 ； 軟性隱形眼鏡 ； 無菌試驗 ； The Classification of Medical Device ； Soft contact lenses ； Good Manufacturing Practice GMP ； Sterility test

藥物食品檢驗局調查研究年報

21號（2003 / 09 / 01）

86 - 92

繁體中文

依據藥事法第十三條、藥事法施行細則第二十六條及衛生署八十九年六月二十一日、九十一年三月二十八日「醫療器材分類分級」公告，軟性隱形眼鏡屬於第二、第三等級產品，依規定須辦理查驗登記，生產該項產品之製造廠，應符合GMP規範。軟性隱形眼鏡種類可區分為一般軟性隱形眼鏡、長戴形、拋棄式及彩色等四種，依規定均係屬須經滅菌之產品。隱形眼鏡因長時間直接覆蓋在角膜上，若滅菌不完全則會直接傷害配戴者的眼球，嚴重感染時甚至有失明之疑慮，由此可見隱形眼鏡是否為無菌性，影響健康甚鉅。由於以往不曾對軟性隱形眼鏡進行市售品抽驗，為保障消費者的健康與安全，本年度委託各縣市衛生局至轄區內軟性隱形眼鏡之製造廠及代理商抽驗檢體，進行無菌試驗測試。各縣市抽得之檢體數共計41件（輸入16件，國產25件），其無菌試驗檢驗結果均合格。由本品質調查結果顯示，市售之軟性隱形眼鏡其無菌性品質尚可。本調查係列為本局之比較檢驗，曾於九十一年十一月十五日發佈新聞在案。

Soft contact lenses are classified as class Ⅱ or class Ⅲ medical device according to ”The Classification of Medical Device” promulgated by Department of Health, Taiwan. Therefore, the soft contact lenses are required to register and their manufacturers should meet the criteria of the Good Manufacturing Practice (GMP). Sterilization is an essential step to manufacture soft contact lenses. If the sterilization step is incomplete, it will cause severe damage on eyes, or even make people blind. In this study, we conduct the sterility survey on soft contact lenses in Taiwan market. Forty-one samples were randomly selected from 9 domestic soft contact lens manufacturers, 14 agencies and 4 optical corporations in Taiwan from May 2002 to July 2002. In this study, all the samples passed the sterility test. Our survey study could provide information on the sterility of the soft contact lenses currentty avail able in Taiwan market. The results also demonstrated the effect on GMP policy of medical devices.