一般市售滅菌紗布及棉花之無菌性監測   全文下載

Sterility Survey of the Medical Cotton Balls and Gauzes in Taiwan

滅菌紗布及棉花是一般民眾居家護理常用的醫療器材，在藥局及醫療器材行即可購得，更常被使用於醫療院所之手術、消毒、止血或包紮，使用時直接接觸於外傷傷口，若因滅菌不完全或運送、保存不當以致遭受微生物污染，將增加感染機會，因此其無菌性相對重要。過去調查分析結果顯示，醫療院所使用之紗布和棉花製品的無菌品質較一般市售產品為佳；鑒於提升民眾使用相關產品之安全性，105年度針對一般市售滅菌紗布及棉花製品之無菌性品質進行監測調查。本研究調查經函請地方政府衛生局配合至轄區內藥局、醫療器材販售商、製造廠及代理商等針對滅菌紗布及棉花進行抽查，並依據中華藥典第七版補篇進行無菌性檢驗。105年度共計抽樣78件產品（紗布48件，棉花30件），結果顯示抽查之78件產品無菌試驗結果全數合格。而監測調查結果亦發現部分產品外包裝標示之中（英）文品名及地址等與藥事法之規定不符，標示不符合產品分屬11張許可證（紗布8張，棉花3張）；上述標示不符合之檢體已函送地方政府衛生局處辦，並同時進行產品之下架及回收改正相關作業，以保障國人之健康及醫療品質。

Cotton balls and gauzes are medical devices used at home or in medical facilities to stop bleeding, surgical prepping, wound cleaning and other personal care. For wound care the above-mentioned products must be sterile. The risks of wound infection may be increased if the products are not completely sterilized or not maintained during transportation or storage. Therefore, the sterility assurance of such products is very essential. The past sterility surveys of the products available in the market showed that the sterility of the wound care gauzes and cotton balls used in the hospitals is better than the over-the-counter ones. In order to ensure the safety of medical devices, a sterility survey of the medical gauzes and cotton balls was conducted in 2016 with the help of local health authorities. 78 samples (48 gauzes and 30 cotton balls) were collected from hospitals, pharmacies and manufactories. The sterility test was conducted according to Chinese Pharmacopoeia Ⅶ Supplement published in 2015. The results showed that all of the samples were complied with the sterility requirements. However, 15 samples from 11 licenses failed to comply with labeling requirements, such as failed to label complete addresses and names of the manufacturers and/or the dealers according to the Pharmaceutical Affairs Act. To protect public health and medical quality, these results have been forwarded to the local health authorities as references, and the suppliers were requested to recall products and correct labeling mistakes.