市售針灸針之安全性調查

The Safety Evaluation of Acupuncture Needles

10.6946/ASRNL.200309.0093

吳美娟(Mei-Chuan Wu)；連淑華(Shu-Hwa Lian)；許慧娟(Hui-Chuan Hsu)；魏秀義(Shiow-Yin Wey)；江建勳(Chieng-Hsun Chiang)

針灸針 ； 一般急性毒性試驗 ； 皮內刺激性試驗 ； 細菌內毒素試驗 ； 無菌試驗 ； acupuncture ； systemic injection test ； intracutaneous test ； LAL test ； sterility test

藥物食品檢驗局調查研究年報

21號（2003 / 09 / 01）

93 - 108

繁體中文

政府為提昇國產醫療器材之品質及國際競爭力，於民國八十八年二月公告實施醫療器材優良規範，因針灸針係屬刺入人體皮膚及肌肉之醫療產品，其品質及衛生狀況值得吾人深入了解。為確知醫療器材製造業是否配合政府政策提昇國產醫療器材之品質，本局請各地方衛生單位於當地醫院、診所及醫療器材行抽樣針灸針檢體共計51件（國產43件；輸入8件）送驗。進行一般急性毒性試驗、皮內刺激性試驗、細菌內毒素試驗及無菌試驗等四項檢驗。結果顯示所有針灸針產品之一般急性毒性試驗、皮內刺激性試驗及細菌內毒素試驗均合格，惟其中9件(17.6%)檢體之無菌試驗結果不符中華藥典及美國藥典之規格，分別為國內廠2家及輸入廠1家所製造；有關產品標示方面，不符規定者計35件(68.6%)，以仿單標籤與衛生署原核准者不符佔最多數，其次為無廠址標示、無批號或製造日期標示、品名及廠名與衛生署原核准者不符等情形。

In 1999, the government published a Good Manufacture Practice Guideline for the industry of medical supplies to help raising the quality and the competition of local products. Acupuncture needles are the type of products that are inserted through human skin and muscle. The quality of these products should therefore be closely monitored. Fifty-one samples were collected by local health authorities in Taiwan and were tested by our laboratory. The methods (systemic injection test, intracutaneous test, LAL test and sterility test) adopted were the methods listed in the Chinese Pharmacopeia, the U. S. Pharmacopeia and the Japanese Guideline to the Test Method of Medical Devices. The results showed that all sampled acupuncture needles passed the first three methods. However, nine samples (17.6%) from two domestic manufacturers and one foreign manufacturer failed the sterility test. Product labeling of thirty-five samples did not comply with the health authority regulations. The labeling and the name of manufacturers of these items were not in consistence with their registration as recorded by the Department of Health. The labels of some of the products did not specify the address of the manufacturer, the lot numbers, the manufacturing date and the name of the product.