英文摘要 |
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. |