Industry Study: 83% of US Temperature Screening Sellers Falsely Say Not Medical Devices
By Joey Walter, Published Jun 29, 2020, 11:31am EDT
83% of US companies selling temperature screening devices, aka 'fever' detectors, claim they are not medical devices, contrary to FDA definition, showing widespread abuse and undue public risk.
Executive Summary – FDA Positions, Seller Responses
The FDA considers devices used to detect elevated skin temperature as medical devices, while sellers acknowledge these purposes and promote them as benefits to sell products, they claim they are not medical devices.
This is causing undue risk to the public and, as our study shows, is widespread. We have forwarded a copy of this report to the FDA so they are aware.
Sellers Not Medical Devices
25 out of 30 sellers are claiming their devices detecting elevated skin temperature are not used for a medical purpose, instead claiming:
"from our perspective we educate dealers that they are not medical devices, not FDA approved, not a fever diagnosing camera" (Brooklyn Low Voltage Supply, reseller)
"These are not medical devices or medical grade devices. Our use is for general purpose temperature" (Nelly's Security, reseller)
"It is not a diagnosis, merely a tool to sort out people faster" (ENS Security, reseller)
"not a fever diagnosing camera" "We are a security company, not a medical company" (123 Security Products, reseller)
Clearly, these products have the ultimate goal of finding potentially febrile individuals during a pandemic. This is a "medical purpose" regardless of what wording the sellers we surveyed use.
30 Sellers Surveyed by IPVM
IPVM surveyed 30 companies who either manufacturer, relabel, or resell these products, including:
We did not survey manufacturers of FDA approved products, since those are, by definition, medical devices.
For the phone calls we conducted, we called the general sales numbers for each company to reflect the normal practice of buyers. When asked what company we were from, we did identify that we were from IPVM.