Clipping Board » Medical Affairs and Administration ─ Medical system, pharmaceuticals, and medical community-related reports
【China Times Health / Yang Gefei Report】2010.10.07
Acupuncture is one of the traditional Chinese medical treatments, and many people have experienced it for rehabilitation, disease treatment, or weight loss, with certain effectiveness. To ensure public safety, the Department of Health recently conducted sterility tests on commercially available acupuncture needles. The results revealed that a batch of needles imported from Vietnam was found to contain bacteria and mold.
Luo Jifang, a section chief at the Research and Testing Division of the Food and Drug Administration under the Department of Health, pointed out that acupuncture needles are devices used to puncture the skin for acupuncture procedures. If they are not properly sterilized, they can easily cause tissue damage or infection. For example, if pathogens are transmitted through acupuncture to diabetic patients, the risk of infection may increase.
As early as 2003, inspections were conducted on acupuncture needles, and substandard products were also detected at that time. Through source management, inspectors visited factories to ensure that the public would not face infection risks when receiving acupuncture.
To comprehensively monitor the sterility quality of acupuncture needles, the Food and Drug Administration requested local health bureaus in June this year to assist in sampling, conducting nationwide source sampling of acupuncture needle specimens.
According to the Department of Health’s data, 18 licenses for acupuncture needles have been issued so far. This time, 14 samples were collected (covering 12 licenses, including 9 domestically produced and 5 imported products) for sterility testing. Among them, one specimen failed the bacteria and mold tests, with a non-compliance rate of 7.1%.
Luo Jifang noted that the non-compliant product was an imported item manufactured in Vietnam, branded as "Gao’s Acupuncture Needles" (Medical Device Import License No. 019334). Local health bureaus have been instructed to handle the matter in accordance with the law. Additionally, the health bureaus have completed the recall and seizure of the non-compliant product and logged it into the national defective medical product reporting system.
To ensure drug safety and medical efficacy, the Department of Health has established a drug safety monitoring mechanism to promptly track domestic and international drug safety information. In addition to setting up adverse drug reaction and defective product reporting systems, the safety and efficacy of drugs are continuously reassessed.
Source: http://health. chinatimes. com/ contents. aspx? cid=5,61& id=11871
Sterility Test of Acupuncture Needles: Vietnam-Made Gao's Needles Failed
Acupuncture is one of the traditional Chinese medical treatments, and many people have experienced it for rehabilitation, disease treatment, or weight loss, with certain effectiveness. To ensure public safety, the Department of Health recently conducted sterility tests on commercially available acupuncture needles. The results revealed that a batch of needles imported from Vietnam was found to contain bacteria and mold.
Luo Jifang, a section chief at the Research and Testing Division of the Food and Drug Administration under the Department of Health, pointed out that acupuncture needles are devices used to puncture the skin for acupuncture procedures. If they are not properly sterilized, they can easily cause tissue damage or infection. For example, if pathogens are transmitted through acupuncture to diabetic patients, the risk of infection may increase.
As early as 2003, inspections were conducted on acupuncture needles, and substandard products were also detected at that time. Through source management, inspectors visited factories to ensure that the public would not face infection risks when receiving acupuncture.
To comprehensively monitor the sterility quality of acupuncture needles, the Food and Drug Administration requested local health bureaus in June this year to assist in sampling, conducting nationwide source sampling of acupuncture needle specimens.
According to the Department of Health’s data, 18 licenses for acupuncture needles have been issued so far. This time, 14 samples were collected (covering 12 licenses, including 9 domestically produced and 5 imported products) for sterility testing. Among them, one specimen failed the bacteria and mold tests, with a non-compliance rate of 7.1%.
Luo Jifang noted that the non-compliant product was an imported item manufactured in Vietnam, branded as "Gao’s Acupuncture Needles" (Medical Device Import License No. 019334). Local health bureaus have been instructed to handle the matter in accordance with the law. Additionally, the health bureaus have completed the recall and seizure of the non-compliant product and logged it into the national defective medical product reporting system.
To ensure drug safety and medical efficacy, the Department of Health has established a drug safety monitoring mechanism to promptly track domestic and international drug safety information. In addition to setting up adverse drug reaction and defective product reporting systems, the safety and efficacy of drugs are continuously reassessed.
Source: http://health. chinatimes. com/ contents. aspx? cid=5,61& id=11871