FDA-Violating Eagle Eye Fever Screening Endangers SchoolsBy Robert Wren Gordon and Gurami Jamaspishvili, Published Aug 05, 2021, 08:52am EDT
Eagle Eye is flagrantly and knowingly violating FDA guidelines with fever screening at a US school district, plus running a marketing campaign for it. Even after IPVM informed them of this violation, Eagle Eye replied 'no comment' and refused to remove the marketing.
Watch the 2-minute video to learn more:
Plus, the Alabama Eagle Eye reseller used deceptive marketing to sell a local school district 30 faulty, non-NDAA-compliant fever cameras that risk violating the NDAA if using federal funds.
Florence City Schools is an eight-institution school district with 4,200 students in Lauderdale County in northwestern Alabama.
The Eagle Eye 'Client Success Story' claims that Alabama-based reseller nSide installed 30 Eagle Eye ST Series Thermal Cameras "at 11 locations," including, presumably, each of the district's eight schools as well as "the Board of Education building, technical resource center, and community learning center."
Nearly $300,000 of sales from nSide to the school district match the timing of the fever camera installation last year, excerpt from GovSpend:
nSide marketed using federal funds (specifically CARES), claiming they would be 'FREE'. However, Eagle Eye / Sunell temperature screening historically used Huawei chips which makes use of federal funds a violation of the NDAA / US law. Neither the school nor the reseller would comment.
Eagle Eye / Sunell
Sunell is the original manufacturer of Eagle Eye's relabelled fever camera. Sunell received an FDA warning letter in March 2021 for marketing its thermal cameras as having the ability to scan multiple people simultaneously, as IPVM previously reported.
FDA Violating Implementation
The doorway entrance screening combined with no inner canthus measurement makes this installation particularly egregious.
1: Multiple People Not Indoors
Per the FDA and international standards ISO/TR 13154:2017 and IEC 80601-2-59:2017, screening should be performed one subject at a time and within climate controlled conditions. This is not the case at Florence City Schools, as the photo clearly shows multiple students being screened while the doors are open:
As reported in our international fever camera standards post, temperature and humidity controls are important to ensure accurate readings:
To produce consistent and reliable results of the temperature screening process, it is imperative that the screening thermograph be situated in a reserved stable indoor environment with a temperature range of 20 °C to 24 °C and relative humidity range from 10 % to 50 %. [emphasis added]
Florence's average humidity ranges above 70% year-round. High humidity is likely to decrease temperature measurements as it reduces emissivity. Additionally, subjects in humid environments are more likely to sweat, also reducing surface skin temperature.
2: Sun-Facing Windows; Sources of Cold
The ISO adds that "sun-facing windows [such as those seen on buses], radiant heaters, or sources of cold (cold windows or outside walls) can also “interfere” with accurate readings.
The Eagle Eye case study photo clearly shows a glass entrance.
Depending on the time of day and the sun's position, sunlight shines directly into the screening area, potentially resulting in false-positive readings as students enter the school.
Lending credence to this point, nSide acknowledged in the Eagle Eye 'Client Success Story' that false positives caused "frustration" at Florence City Schools:
There was a level of frustration at the volume of false positives. We quickly understood we needed to provide more education around the understanding that false positives are okay. It’s the statistical norm; it’s what you should see. [emphasis added]
4: Screening Is Not Orderly/Faces Obscured/Heads Covered
Also violating standards, multiple students are being screened simultaneously with their faces obstructed by facemasks, hats, hair, etc:
5: No Inner Canthus Measurement
Eagle Eye/Sunell 'fever' cameras (see tweet below) only measure temperature from the forehead, and not the inner canthus, therefore, sun shining directly onto a person's forehead contributes to errors.
'Eye Duct' Screening
nSide claims on its website that its temperature screening measures from the inner canthus:
nSide|Live + ETS locates and scans each person’s eye ducts, providing the core and most accurate body temperature possible. [emphasis added]
However, the Eagle Eye/Sunell product that nSide resells does not do inner canthus/'tear duct' screening and measures forehead temperature only, something IPVM confirmed in our Sunell testing and with Sunell itself.
Eagle Eye/nSide Willingly Violate FDA Guidelines
Nonetheless, both Eagle Eye and nSide willingly violated FDA temperature screening guidelines.
Eagle Eye: "No Comment"
Eagle Eye declined to respond to an IPVM request for comment:
[O]ur response for this story will be 'no comment.'
IPVM had asked the Texas cloud company to confirm the NDAA compliance of its fever cameras, since nSide has promoted CARES Act funding for its 'Elevated Temperature Screening':
nSide: "No Comment"
nSide founder Dr. Steven B. McKinney (pictured), who holds a PhD in Environmental Health Engineering from the University of Alabama at Birmingham, declined to explain nSide's Florence implementation and his company's questionable fever camera marketing:
Please accept my official response as “no comment”.
Florence City Schools: No Response
No response was received from Florence City Schools despite us contacting the Superintendent's office, the Chief School Finance Officer, and the Director of Instruction and Technology at Florence City Schools repeatedly.
Not Following FDA Guidelines
The FDA is clear about the accuracy problems of multiple person screening:
Thermal imaging systems have not been shown to be accurate when used to take the temperature of multiple people at the same time. The accuracy of these systems depends on careful set-up and operation, as well as proper preparation of the person being evaluated. [emphasis added]
Already Warned Sunell
Eagle Eye is well aware that they are violating the FDA as their supplier Sunell received an FDA warning letter for such violations 5 months ago:
School District Risks
School districts in Alabama such as Florence City and Baldwin County Public Schools as well as elsewhere in the US are under great pressure to get students back in class. But poorly selected, planned, and implemented fever cameras systems are not only costly financially but a risk to the health and safety of their very own students.
For related coverage, see:
- Hikvision Temperature Screening Outdoors And In Buses
- CDW Sells School District 36 Low-Res, No Blackbody Hikvision Fever Cameras With Federal Funds
- Hikvision Impossible 30 People Simultaneously Fever Claim Dupes Baldwin Alabama
- School District Admits Not Following FDA Guidelines With 144, No Blackbody, Hikvision Fever Cameras
- Alabama Schools Million Dollar Hikvision Fever Camera Deal
3 reports cite this report:
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