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New Guidance From the FDA on Fever Detection Devices

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As the world slowly returns to work and public spaces, technology is being leveraged to keep the coronavirus in check and prevent spread of the contagion. Many in the workforce and others will soon find themselves part of new efforts to contain the virus, such as thermal imaging and fever detection cameras used as a first defense in spotting elevated body temperatures.

Thermal imaging cameras have been part of traditional physical security surveillance, especially outdoor perimeter detection, for many years. These surveillance systems can read and distinguish temperature differences in a person or object and many are now sophisticated software solutions with artificial intelligence. They can be integrated with other technology, such as facial recognition and access control. In the instance of thermal fever products for physical security, the devices detect whether a person has an elevated skin temperature and are then paired with a secondary method of gathering data, such as forehead or skin temperature detection.

Now these solutions have a reimagined niche targeting those returning to work. It’s a different twist on deployment, with new products and designs flooding the market. As such, there’s been confusion over what these devices can do, how to properly install and calibrate them and even claims the technology doesn’t work. The Washington Post called it the “nationwide gold rush for thermal scanners” as companies clamor to compete in the space.

In April 2020 the Food and Drug Administration (FDA) issued a guidance covering thermal/fever products and placed them under the category of medical devices and subject to its regulatory control. Issued by the Center for Devices and Radiological Health, Office of Product Evaluation and Quality, the publication was developed  aid in the public health emergency caused by COVID-19 and provide information on proper deployment and effective implementation.

“FDA is issuing this guidance to provide a policy to help expand the availability of telethermographic (thermal fever) systems used for body temperature measurements in triage use for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020,” it stated.

Thermal cameras as medical devices

The FDA defines the technology in this usage as “devices intended for a medical purpose, such as measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body.”

The guidance cites potential use of the technology as high-traffic and throughput areas, such as airports, businesses, warehouses, factories and areas where other temperature assessment products are not readily available.

Manufacturers, importers and distributors of thermal imaging products deployed in construction or industrial applications and marketed as nonmedical applications are exempt from 510(k) marketing authorization clearance that makers of devices for medical purposes must follow. This exemption is temporary and only in effect related to the duration of the COVID-19 public health emergency. The FDA will be on the lookout for products that create an “undue risk.”

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. The FDA recommends that manufacturers of telethermographic systems that were not previously intended for medical purposes, but now are, to review the enforcement policy in Section IV.C of the guidance.

The FDA further recommends the devices use labeling that helps users better understand the solution and its deployment. Such labeling could include a prominent notice and statement that the measurement should “not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease; and an elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g., non-contact infrared thermometer or clinical grade contact thermometer).”

In this time of uncertainty, one thing is clear: the world is going to look very different post-COVID-19 in comparison to just a few months ago. Using thermal imagers as fever detection devices may be just the first example in a line of repurposed tools.

About the Author

Deborah L. O’Mara

O’MARA is a journalist with more than two decades experience writing about security, life safety and systems integration, and she is the managing director of DLO Communications in Chicago. She can be reached at dlocommunications@gmail.com or 773.414...

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