Deceptive Meridian Temperature Tablets Endanger Public SafetyBy John Honovich, Published Oct 21, 2020, 01:22pm EDT
Meridian has sold these devices to school districts in at least 9 states as well as the US Air Force and the US Veteran's Administration (re-sellers include CDW and Staples), according to a government records review IPVM has done, highlighted below:
'Not A Medical Device'
We bought the device from Meridian and the unit itself plainly declares that "This is not a medical device" as the excerpt below shows:
It Is A Medical Device, Per The FDA
However, it is a medical device, per the FDA. All devices that screen for elevated human temperatures are considered medical devices by the FDA.
Country of Origin Not Disclosed
Secondly, the unit has no country of origin marked on the unit. However, US law requires devices to be marked with their country of origin, see 19 U.S.C. § 1304 - U.S. Code Title 19. Customs Duties § 1304 | FindLaw.
The closest Meridian gets to addressing where this is made is their FAQ where they avoid answering their own question of where it was made, saying:
Where is the Personnel Management Kiosk manufactured?
We have parts from USA, China, and Germany that make up the Personnel Management Kiosk, with all final assembly, testing, software setup and shipping from Aberdeen North Carolina USA.
Verified Made in China
However, we verified that the unit was made in China by buying the Meridian unit (for $2,600) and the same fundamental unit from China ($600), as the hardware side by side below shows:
Moreover, we examined the software and UI for both models which matched with only minor cosmetic differences, as shown below:
Meridian separately sells MzeroManagement, an add-on management software.
Performance / Accuracy Problems
Most importantly, we tested the Meridian device we bought from them and found it had fundamental accuracy problems detecting elevated temperatures:
The Meridian, much like the China tablets we have tested, normalized temperature readouts, which has the positive impact of making people think that they are safe but the negative public health risk of missing people who are febrile.
For more, see IPVM's temperature tablet shootout.
We previewed our concerns with Meridian. Meridian sent a 2-page response to IPVM.
On the China sourcing, Meridian first said they could provide evidence to disprove us:
None of our components are sourced through BEMS or other resellers, thus we are not a relabel of the BEMS unit. We can provide further evidence to this fact if needed.
However, when we asked for that evidence, they declined to provide. The evidence from our testing clearly shows its China sourcing.
On the made in US element, Meridian said it does not represent that it is "made in the USA" but that the "full kiosk is manufactured and assembled in the USA":
Meridian does not represent that our product, as a whole, is “made in the USA”. Our product contains components sourced from the US, China and Germany, as made clear in our documentation. The head unit, made in China, and the Thermopile Sensor, made in Germany, are components of the full kiosk which is manufactured and assembled in the US.
The 'head unit', as they call it, is the fundamental device itself. It is the core hardware and the software that runs the system, the stand they attach it to is ancillary, at best, and not transformative.
On the medical device element, Meridian told IPVM that they are "currently pursuing 510(k) certification". However, an FDA 510(k) is only needed by medical devices yet Meridian's device is labeled 'not a medical device'. We noted this discrepancy to Meridian but they declined to comment further.
Furthermore, Meridian provided us an Opinion Letter RE: Regulatory Status of Kiosk with Thermal Camera, with their attorney noting that the FDA considers such devices "regulated as medical devices":
In this enforcement policy, FDA states that telethermographic systems intended for a “medical purpose,” are regulated as medical devices. FDA construes “medical purpose” broadly, to include body temperature assessment, even when not in a healthcare environment.
We agree with this attorney. The FDA does consider their device to be a medical device, contrary to Meridian's labeling on their product.
Simplistic Test Process Disclosed
Notably, the letter also gives insight into the simplistic testing process Meridian claims, saying:
Laboratory temperature accuracy was assessed over a temperature range of 34- 39°C, and the measurement uncertainty was confirmed to be less than or equal to ±0.5°C. The system uses the NightinGale blackbody temperature reference source, which is set at 12 inches from the sensor face.
This testing process is significantly easier to achieve than what Meridian actually markets, much closer and much larger than the area of a human elevated temperature. For example, the subject distance Meridian recommends is 75% farther away, at 20 inches versus the 12 inches this test specifies. Moreover, the blackbody they used has a "3” Square Emitting Aperture", which is much larger and more uniform than the area of a face that typically shows the subject's maximum temperature. This is, of course, not the fault of the blackbody but the test process used.
While the letter provides no further details on the test and the attorney author did not respond to our request for comment, this 'test' reveals a process that does not properly represent their use case and the flaws risked in doing so.
Risk To Public Safety
As IPVM has reported throughout 2020, this fits an ongoing trend of significant amounts of money being spent on devices that may not help public safety. Worse, the false sense of security these devices contribute to could make things even worse, while deceptive sellers like Meridian profit.
2 reports cite this report:
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