For immediate release:

The United States Food and Drug Administration today alerted consumers, healthcare providers, and others to thermal imaging systems intended to measure human body temperature – also known as telethermographic systems. , infrared thermographs, thermal cameras and “fever cameras” – the systems can provide inaccurate temperature readings due to a variety of factors. In addition, the FDA has issued several warning letters to certain companies offering unapproved, unauthorized, and unauthorized thermal imaging systems for sale.

“Although thermal imaging is not an effective diagnostic device for COVID-19, it can determine if a person has an elevated temperature, which can be an important risk management tool during the pandemic when it is. used correctly, ”said William Maisel, MD, MPH, Chief Medical Officer and Director of the Office of Product Quality and Assessment at the FDA’s Center for Devices and Radiological Health. “But improper use and marketing of thermal imaging systems can lead to inaccurate temperature readings and pose a potential danger to public health. As part of the FDA’s continued commitment to transparency to the American public, the agency provides important information to users on the correct use of these devices and warns some companies that the FDA will not tolerate their marketing of products. mislabeled and adulterated.

Thermal imaging systems for measuring the temperature of the skin on a person’s surface are regulated as devices by the FDA. Thermal imaging systems detect infrared light emitted by a person’s skin and convert that information into a temperature reading. The FDA is aware that thermal imaging systems can be used as a means of sensing temperature as part of a broader approach to COVID-19 risk management, for example in combination with wearing a mask, social distancing and hand washing, to provide initial temperature assessments or triage individuals for high temperatures in public spaces such as airports, grocery stores, offices and schools. When designed and used correctly, thermal imaging systems have been shown to accurately measure the temperature of the skin on a person’s surface.

Misuse of thermal imaging systems can lead to inaccurate body temperature readings which can present potentially serious risks to public health. These risks can include, but are not limited to, the device incorrectly sensing normal human body temperature when a person has an elevated temperature and incorrectly rating a person as having an elevated body temperature when they do not. . These risks are more likely to be present when thermal imaging systems scan multiple people simultaneously. To help mitigate these risks, the FDA provides important recommendations in safety communication to consumers, healthcare providers, and other users on the appropriate and inappropriate use of these systems.

The FDA is also aware that some companies market unapproved, unauthorized, and unauthorized thermal imaging devices for measuring human body temperature, including measuring the temperature of multiple people at the same time, and has issued letters d warning to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd. and Thermavis. The FDA’s position is that warning letters are only issued for violations of regulatory significance. Warning letters issued by the FDA are posted on the Warning Letters page and COVID-19 related warning letters are posted on the Fraudulent Coronavirus Disease 2019 (COVID-19) Products page of the FDA.

The FDA can take additional steps, if necessary, to protect consumers.

If you would like to report a problem with a thermal imaging system, you can do so through the MedWatch Voluntary Report Form.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.

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