Contact: Tsai, Ying-Chiu
Telephone: 037-558211
In response to epidemic prevention in the community, all units and public places have recently purchased body temperature monitoring devices. The most common one is a device designed to measure hand temperatures and provide an alcohol mist spray. It is used to determine whether the body temperature of a person is normal when they enter and exit a space. According to the Public Health Bureau of Miaoli County Government, this type of device has not been approved with a medical device license by the Taiwan Food and Drug Administration. Because of this, it can only be used referentially. It is advised that all units prepare an approved thermometer with a medical device license as the main protocol to measure body temperature and fever.
According to the Medical Devices Act, a device used to measure body temperature must be approved with a medical device license. There are five types of medical devices: forehead thermometers, ear thermometers, oral thermometers, digital thermometers to take underarm temperature, and rectal thermometers. The stores that sell medical devices must provide information on the maintenance and regular inspection of such. Considering that hand temperature can easily change in an individual (including by peripheral blood circulation) and the environment, it is currently not used as definitive proof for a fever diagnosis. In addition, the devices used to measure hand temperature have not been approved as medical devices by the Taiwan Food and Drug Administration.
Thermometers are medical devices and so the Pharmaceutical Affairs Division of the Public Health Bureau reminds people to purchase medical devices that have a license and are registered by the Ministry of Health and Welfare. Moreover, three steps can assist people in choosing a registered medical device. The first step is to find out if a thermometer is a medical device. Secondly, check the registration number of the medical device license that is printed on the package or label when purchasing a product. The last step is to read the instructions of use carefully before using the device. By following these steps, you can purchase a registered medical device and feel assured of its license when using it. Please contact the Public Health Bureau of the Miaoli County Government by phone at (037) 558080 or go to your nearest public health center for inquiries.