滅菌針灸針之無菌性監測   全文下載

Sterility Surveillance of Acupuncture Needles in Taiwan

針灸針是用於穿刺皮膚作針灸行為之器材，使用時須穿刺人體皮膚及肌肉，而市面上針灸針大多經環氧乙烷或放射線照射滅菌，若因滅菌不完全或運送、保存不當以致遭受微生物污染，使用後易造成局部發炎等感染症狀，故其無菌性實為重要，為提升民眾使用安全性及降低感染風險，有必要監控針灸針之無菌性。依過去調查分析結果顯示，仍有部份產品無菌試驗不合格情形，有鑑於此，本計畫監測國產及國外輸入且標示「無菌」或「滅菌」針灸針許可證，委由地方政府衛生局抽樣，再由食品藥物管理署（以下簡稱食藥署）依據中華藥典第七版補篇進行無菌試驗。本年度總計抽樣56件檢體，有效許可證共23張（涵蓋率達95.8%），無菌試驗結果全數合格。此外，本次調查亦發現12件檢體（含5張許可證）有包裝標示之缺失，包括英文品名與許可證登記不符、未標示製造廠名及廠址、製造廠址與許可證登記不符等情形，上述不符合情形均函送各轄區衛生局後續處辦，並要求廠商限期回收違規市售產品連同庫存品進行改正，以保障國人之健康及醫療品質。

An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. Most of the market available acupuncture needles are sterilized by ethylene oxide or ionizing radiation. Microbial contaminations may happen due to insufficient sterilization or improper delivery/storage processes. In order to ensure the user safety, it is necessary to periodically monitor the sterility of the market products and thereby reduces the risks of infections caused by microbe-contaminated needles. Since 2002, TFDA has been monitoring the sterility of acupuncture needles on the market, and found a few contaminated products in the earlier surveys. Last year (2016), we conducted the market survey again in order to inspect the sterility of the market available acupuncture needles. From January to June in 2016, our local health authorities collected 56 samples (include 23 licenses, the recovery rate is 95.8%) from hospitals, clinics, pharmacies and factories all over Taiwan. Sterility tests of the samples were conducted in accordance to the Direct Transfer Method prescribed by the Chinese Pharmacopoeia VII Supplement published in 2015. The sterility test results showed that all the samples were free of microbial contamination. However, we found that 12 samples (including 5 licenses) failed to comply with the labeling requirements stipulated by the Pharmaceutical Affairs Acts (such as failed to add manufacturer name and address, failed to label product name / manufacturer information as registered, etc.). These findings have been forwarded to the local health authorities as references while the corrective actions of the product suppliers and manufacturers were requested. In addition, TFDA will strengthen the education and the regulatory control of medical devices to achieve a better protection of the public’s health and safety.