Companies that sell thermometers that measure skin temperature and claim they can detect fever are breaking the law and would face fines of up to NT$25 million (US$892,953), the Food and Drug Administration (FDA) said on Monday.
Only forehead, ear, oral, armpit and rectal thermometers are approved by the government to measure body temperature and gauge whether a person has a fever, the FDA said.
The government has not approved for medical purposes devices that measure the temperature of the skin using an infrared tympanic thermometer, it said.
Skin temperatures detected by such devices, which are commonly incorporated into sanitizer dispensers at convenience stores, supermarkets and government agencies, can only be used as a reference, because the devices are not approved for medical use, the FDA said.
Hand temperature is easily affected by peripheral circulation or the environment, and varies significantly from true body temperature, FDA Medical Devices and Cosmetics Division specialist Lin Hsin-hui (林欣慧) said.
There are also no clinical trials that prove hand skin temperature is a valid determintor of whether a person has a fever, Lin said.
Importing, manufacturing or selling such devices for medical purposes is illegal, and those who do could face a jail term of up to three years and a fine of up to NT$10 million for contravening the Medical Devices Act (醫療器材管理法), she said.
Those who claim that the devices can be used to check for a fever can be fined NT$600,000 to NT$25 million, she said.
As most people who catch COVID-19 develop a fever in the initial stages of the infection, the FDA urged people to monitor their temperature with a thermometer approved for medical purposes.
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