The FDA is alerting consumers that improper use of thermal imaging systems could lead to a false analysis of temperature that many companies include in their COVID-19 screening protocols.
“While thermal imaging is not an effective diagnostic device for COVID-19, it can determine if someone has an elevated temperature, which can be an important risk management tool during the pandemic when used properly,” said William Maisel, Chief Medical Officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health in a statement.
This week, the FDA also issued several warning letters to firms that are currently offering for sale unapproved, uncleared, and unauthorized thermal imaging systems.
Thermal imaging systems are also known as telethermographic systems, infrared thermographs, thermal cameras, and “fever cameras,” that are intended to measure a person’s surface skin temperature and are regulated by the FDA.
They work by detecting infrared light emitted from a person’s skin and then converting that information into a temperature reading. Thermal imaging systems are currently in use as a screening tool to detect temperature in many institutions, as part of a larger approach to COVID-19 risk management. In public areas such as airports, grocery stores, offices and schools, the use of thermal scanners allows an organization to provide initial temperature assessments and then triage individuals into preset protocols should the thermometer return a result displaying an elevated temperature reading.
When designed and used correctly, thermal imaging systems have been shown to accurately measure someone’s surface skin temperature, said the FDA.
“But improper use and marketing of thermal imaging systems may lead to inaccurate temperature readings and pose a potential danger to public health,” said Maisel. “As part of the FDA’s ongoing commitment to transparency to the American public, the agency is providing important information to users about the correct use of these devices and is warning certain firms that the FDA will not tolerate their marketing of misbranded and adulterated products.”
The FDA has issued Warning Letters to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd., and Thermavis.
“Warning Letters are issued only for violations of regulatory significance,” is the position of the administration, reads the issued press release regarding this matter. Warning Letters that have been issued by the FDA are published on the FDA Warning Letters page, and COVID-19 related Warning Letters are published on FDA’s Fraudulent Coronavirus Disease 2019 (COVID-19) Products page.
