A lot of places are using these handhelds… even though they don’t seem accurate. Thermal imaging is complicated. I just want something that works and doesn’t cost too much. Does this do that?

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 Buyers have noticed that low-cost, imported thermal imaging handhelds, tablets, and other systems are highly inaccurate. The reason they are inaccurate is they are un-scientific. Medical doctors don’t use them in clinics or hospitals because they are not designed to accurately read human body temperatures.

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 NOTE: Most normal adult body temperatures vary 97.5-99.5F. However, many inaccurate thermal imaging devices routinely show:

• Random body temperature reading of <95F, indicating hypothermia

• Random body temperature readings of  >100F, indicating a “false positive” for fever

• Constant “normal” temperatures, like 98.6, for everyone, in every condition

 

 These devices are heavily marketed for their infrared thermal imaging sensor “temperature screening” capability. Typically, they use an infrared sensor which has single pixel of resolution, or a few dozen. Many people have figured out that these cheap devices don’t work. The reading displayed is just a number - more “safety theater” than actual safety.

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Aren’t some carriers of COVID-19 asymptomatic?

 

 Yes, and no screening process is perfect. However, science-based thermal imaging for fever detection is about controlling what can be controlled. Several clinical trials consistently show fever as a primary symptom of COVID-19 (as well as influenza, SARS, H1N1, and other viruses) and the U.S. Food & Drug Administration’s (FDA) most recent guidance on thermal screening during the COVID-19 Public Health Emergency https://www.fda.gov/media/137079/download states, “Fever is a common symptom of COVID-19…” and thermal imaging provides a temperature assessment in “high throughput areas (e.g. airports, businesses, warehouses, factories)” and other settings.

 

 Moreover, according to a published 2018 paper, Best practices for standardized performance testing of infrared thermographs intended for fever screening by U.S. Food & Drug Administration (FDA) staff, “Infrared (IR) modalities represent the only currently viable mass fever screening approaches for outbreaks of infectious disease pandemics such as Ebola virus disease and severe acute respiratory syndrome.” - Ghassemi P., Pfefer TJ, Casamento JP, Simpson R., and Wang Q. (2018), PLoS One. 

 

Is the FIP-S a medical device?

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 Yes, Fever Inspect is a Class II medical device, according to its intended use. However, the FDA’s emergency COVID-19 guidance on thermal imaging used for fever detection notes that the FDA “does not intend to object to the distribution and use” of thermal imaging devices for assessing “initial body temperature.”  In short, the FDA does not appear to, at the moment, be regulating thermal imaging devices used for temperature screening. As a result, a “Wild West” attitude prevails regarding claims and marketing tactics. We expect this to change and for the FDA to start weeding out bad actors. Unlike many others,  Fever Inspect is specifically designed for clinical accuracy.

 

Among the “FDA recommends” in its COVID-19 Public Health Emergency guidance are thermal imaging devices with:

• Accuracy of +/- .5C

• “An accurate blackbody temperature reference source” as well as guidance on blackbody protocols

• Measuring only one subject’s temperature at a time

• Installation guidelines concerning screening background radiation, ambient temperature, airflow and other environmental factors

 

 NOTE: Despite marketing claims by some thermal imaging devices, no thermal imaging system is “approved” by the FDA specifically for fever detection. None.

 

How does Fever Inspect handle regulatory and legal issues involving temperature reading as personal medical information?

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 Very few (if any) thermal imaging devices for fever detection are paying attention to legal and regulatory exposures. Because of Fever Inspect’s expertise in thermal imaging and medical information we designed the FIP-S to protect operators and users. We are aware of law firms in California preparing lawsuits associated with thermal imaging.

 

 It is only a matter of when, not if, the FDA will regulate thermal imaging devices. Much like the FDA’s regulatory pushback on methanol-laced hand sanitizers, as noted here: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use

Fever Inspect is Made in America. Its mission is the safety of organizations who use it, the people who are being screened, their families and friends. Therefore, it is uniquely designed to accommodate U.S. regulatory changes associated with a Class II medical device. As such, the Fever Inspect ensures legal and regulatory matters, such as the FDA, Protected Health Information (PHI), the Health Insurance Portability and Accountability Act (HIPAA), Occupational Safety and Health Association (OSHA), U.S, Equal Employment Opportunity Commission (EEOC),  Americans with Disabilities Act (ADA), and others, are addressed. 

 

 A few examples of how Fever Inspect does this operationally:

•  ADA: Fever Inspect is designed to capture temperature readings of people who are 7-feet tall while also detecting temperatures for individuals in wheelchairs

• PHI, HIPAA: Fever Inspect captures and displays temperature readings. It does not attach specific reading data to specific individuals, nor does it retain such data. This minimizes the operating organization’s PHI and HIPAA regulatory exposure. (However, organizations may choose to align temperature reading data and individuals via custom integrations of Fever Inspect as is appropriate to their organization.)

 

As the U.S. regulatory situation continues to evolve and organizations differ, we will continue to provide our best guidance to ensure the safety of organizations and people.

 

Where is Fever Inspect made?

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Fever Inspect is proudly Made in America. The Fever Inspect team is composed of individuals from Minnesota with expertise in imaging physics, thermography, and high-tech innovative products and companies. Fever Inspect components are primarily sourced from the United States and Europe. Manufacturing takes place in Minnesota.

 

Why are blackbodies so important for accurate temperature screening?

 

Despite many marketplace claims, the best degree-of-accuracy an infrared thermal camera without a blackbody can maintain is +/- 4F.  

A 4F temperature range is too wide to accurately detect fevers while avoiding false positives. That is why even very high resolution infrared cameras marketed for temperature screening also strongly recommend an additional blackbody piece of equipment. Even the best infrared thermal imaging cameras “drift” overtime and require calibration with a blackbody to maintain accuracy.

 

External blackbodies need to be set up and maintained by trained personnel, and preferably a thermographer. Introducing multiple pieces of equipment to a location like an external black body and a seperate infrared camera means adjustments to the operating setup will also throw off the calibration. By contrast, Fever INspect’s integrated blackbody means the calibration process is automated. Ease of use means Fever Inspect operators can simply plug the device in and begin screening. 

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Organizations won’t get “stuck” with an expensive thermal imaging camera and an external blackbody that gets out of calibration - and ends up sitting in a storage locker.

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Some devices also have small operating footprints.  What makes the Fever Inspect small operating footprint unique? 

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As noted by the FDA and industry experts, blackbodies are the “gold standard” for creating the degree-of-accuracy needed for detecting low grade fevers (~100.4F) while avoiding the disruption and cost of false positives.  Fever Inspect is unique because instead of using a single external blackbody it has dual internal blackbodies. As a result, Fever Inspect does not require the additional space a thermal imaging device with an external blackbody needs. In fact, it has the smallest operating footprint for highly accurate temperature screening using blackbody temperature references. 

 

Example of a thermal imaging camera using a single, external blackbody next to a person being scanned. The operating footprint is 6 feet wide by 6-16 feet long (36 - 96 square feet) to accommodate multiple pieces of  equipment, cords, traffic flows....

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The unique Fever Inspect dual, internal blackbody operating footprint is 2-3 feet wide by 2-5 feet long (4 to 15 square feet). 

 

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For organizations seeking to avoid over-sized kiosks and large operating footprints creating chokepoints with multiple pieces of equipment in high-traffic areas exposed to cords and fall damage (and injuring people)

the Fever Inspect- Standalone is used in smaller, more secure areas,

• school foyers, 

• elevator entrances and exits, 

• hallways, 

• cubbies,  

• side doors, etc…

 

where it is used effectively and without causing chokepoints.  As a result, organizations can deploy highly accurate blackbody based temperature screening flexibly.