School District Admits Not Following FDA Guidelines With 144, No Blackbody, Hikvision Fever CamerasBy Charles Rollet, Published Aug 21, 2020, 09:02am EDT
The Baldwin County School District has admitted it is not following FDA guidelines for its Hikvision fever camera system. This is in response to IPVM reporting such risks and CBS affiliate WKRG's investigation.
The FDA declared, in May, that these systems "work effectively only" when these guidelines are followed.
The district also released its contract for the system, confirming it does not use blackbody devices, which are crucial for accuracy. Yet school officials doubled down at a press conference, saying the cameras "have done exceptionally well" since schools reopened last week and potential accuracy issues "doesn't concern us", even while stating system accuracy is not being tracked.
The district even wrongly claimed that Hikvision cameras were the only reasonable/ affordable choice, telling local news "it was these cameras or none at all."
Finally, the district defended its usage of Hikvision - a Chinese government-controlled company that has been sanctioned over human rights abuses - by dismissing "conspiracy theories out there" and stating "we haven't had any conversations with China, I don't call China up, China doesn't call me".
Not Following FDA Guidelines
The school district's CFO admitted, even emphasized, that they were not following FDA guidelines to WKRG:
The full quote is below:
WKRG News: But the Chief Financial Officer for the school system says they never intended to buy that [blackbody] device or follow FDA guidelines.
School Chief Financial Officer John Wilson: We're not looking for that, we're just looking for an early warning system that will allow us to identify the children or employees that have above normal temperature so then we can move forward with individual screenings [emphasis added]
Work Order Released, Confirms No Blackbody Devices
The district released the single-page million dollar order, screen-capped below:
While the document confirms no blackbodies were obtained, the document does not even list the model number of the Hikvision thermal cameras sold.
Risk For Children
The school defended the system the deployment in a press conferencing emphasizing 'no false readings':
The full quote was said at this point in the press conference and is reproduced below:
Reporter: Some have said that you may not be able to register temperatures at 30 [people] per second, it should be more of a one-at-a-time, the camera needs more time to really register that temperature accurately, it's been brought up as a reliability...
Anthony Sampson, Director of Prevention & Support Services: it hasn't been brought up as a reliability from our nurses. We rely on Hunter Security to vet the technology so that we can use the technology. The nurses have not given me any indication that they're being inundated with false readings or this reading or that reading, it's doing what it is designed to do and it's helping them facilitate their assessment of students [emphasis added]
While it is quite possible that there have been no false positives (i.e., students without fevers detecting as having fevers), the most significant risk is false negatives (i.e., students with fevers that the system does not detect as having a fever). Indeed, this is the most significant risk we have found with Hikvision and other 'fever cameras' especially when deployed without a blackbody.
False negatives are particularly problematic as they give the impression that the system is running smoothly (with no errors or 'false' reads). During the conference, Anthony Sampson stated that the cameras "have done exceptionally well" since schools reopened last week.
The full press conference is embedded below:
"No Need" For Tracking Accuracy
In the press conference, Superintendent Eddie Tyler stated the district is not currently tracking system accuracy because "right now there is no need for that":
If you're coming in and you got 100.4 [from the camera system] or higher you're going to the nurse, and the nurse puts the infrared to the forehead and it's 98.6, are we tracking those things? If we felt that was something that was becoming an issue then we would hear that from the nurse. But right now we rely on Hunter Security, so that's a valid question, but right now there is no need for that, we feel comfortable with what we're doing and if all of a sudden it seems like it was just getting really sideways we would address it with Hunter Security, but right there everything seems to be good [emphasis added]
Clearly, if accuracy is not being tracked, there is even less of a chance the district will realize there are any accuracy issues. However, on the accuracy, Anthony Sampson, Director of Prevention & Support Services, stated it "doesn't concern us" because the system is "front-line, first-line" defense:
Reporter: when someone or anyone questions the accuracy and reliability of the cameras, I mean does that concern all of you, are you saying maybe we should take a second and look...?
Anthony Sampson: it doesn't concern us because at the end of the day the thermal camera that's above your head it's a screening mechanism. As Mrs Broughton [Principal of Fairhope East Elementary] said, it's a front-line, first-line defense. So if it gives us an indication, OK, maybe I need to go check on that. Nurses then fall in and they check and they validate and they look for the symptoms and they follow the appropriate protocol and if a kid needs to go home, they go home. [emphasis added]
Nonetheless, a "front-line" system is of little use if it misses fevers in the first place.
"These Cameras Or None At All"
In another local news report, the school district was quoted as stating "it was these cameras or none at all":
Ask Hunter Security, Says School District
The school district superintendent admitted not knowing about the technology, deferring to Hunter Security who sold them these cameras, saying:
I'm sorry, you're not going to get an intelligent answer from a superintendent that is involved in education. but we're dealing with Hunter Security. they are subject matter experts. and so I would direct any further questions that you might have about the cameras to Hunter Security.
There could be some that are FDA approved, and that's terrific. They probably cost ten times than what the school board was able to budget for this project
That is not true. There are many options at equal or significantly lower prices that follow FDA guidelines, such as:
- FDA cleared FLIR has EST specific models in the same price range as Hikvision.
- Seek, whose Scan product does follow FDA guidelines costs just ~$2,000 for a full system including a blackbody, a fraction of what Hunter charged the school district plus actually scans the inner canthus, unlike Hikvision which only measures the forehead.
- Kentix has a model under $1,000 that scans the inner canthus, following FDA guidelines
- And for really low-cost options, there is the K3 / K7 models for a few hundred dollars that are wall-mounted IR guns, similar to commonly used hand-held IR guns but faster and without the risk of cross-contamination.
All of these, in IPVM testing, had better accuracy than Hikvision without a blackbody. And the later 3 options listed (one US-made, one German-made, one China-made) would all have saved the schools hundreds of thousands of dollars.
"I Don't Call China Up, China Doesn't Call Me"
IPVM's investigation also noted the ethical issues with buying cameras from Hikvision, a PRC government-controlled company that has been sanctioned by the US government over human rights abuses. In response, Superintendent Eddie Tyler dismissed "conspiracy theories out there" saying "everything we're doing is legal":
we haven't had any conversation with China, I don't call China up, China doesn't call me. I know there's all kind of conspiracy theories out there, but everything we're doing is legal. We have one of the best law firms around, it's Stone Crosby. They advise us, they guide us, so we're very comfortable with what we're doing in our schools to protect our students and our employees. [emphasis added]
No one has claimed any 'conversations' between the school district and 'China'.
Problems With No Blackbody
Blackbody devices are crucial to accuracy as they provide a reference temperature for the system to properly calibrate. IPVM's own testing of Hikvision's thermal system found it became less accurate without the blackbody, with both increased false alerts and missed detections. Hikvision itself recommends blackbody usage for its thermal cameras:
Not Following FDA Guidelines Problems
The FDA is clear that screening multiple people at once is inaccurate:
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]
'Fever cams' are considered medical devices by the FDA, meaning the FDA regulates their sale and use. The FDA has told IPVM that it "does not intend to object" to these devices' usage only as long as they are used "under the circumstances described in the guidance and where such use does not create undue risk".
While many users, in practice, violate FDA guidelines, this is the first instance IPVM has found of a user announcing they do not follow FDA guidance. Penalties for FDA violations run the gamut, from a "warning letter" to fines and criminal prosecution.
Districts are certainly under great pressure to get back to school but poorly selected, planned, and implemented fever cameras systems are not only costly financially but to the health and safety of the public.
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