FDA Safety Communication: Improper Use of Thermal Imaging Devices

A fever or higher body temperature is only one possible symptom of a COVID-19 infection. Although thermal imaging systems generally detect a high body temperature accurately when used properly, they do not detect any other infection symptoms. It is understood that not all COVID-19-positive individuals will have an elevated temperature, so temperature should not be the only sign or symptom included in an evaluation for the disease. Therefore, a temperature measurement, including a measurement obtained using a thermal imaging system, should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19. A diagnostic test must be performed to determine if someone has COVID-19.

Improper use of thermal imaging systems may lead to inaccurate body temperature measurements which can present potentially serious public health risks. Such risks may include, but are not limited to, the device incorrectly detecting a normal human body temperature when a person has an elevated temperature and incorrectly assessing a person to have an elevated body temperature when they do not. These risks are more likely to be present where thermal imaging systems scan multiple individuals simultaneously. To help mitigate these risks, the FDA is providing important recommendations to consumers, health care providers and other users about the proper and improper use of these systems.

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