SIA’s Don Erickson has written to Stephen Hahn of the U.S. Food and Drug Administration, on behalf of the association, to advise that “some companies and solutions that are not following FDA guidelines and the standards within, while claiming to detect elevated human temperatures for the purpose of mitigating the spread of disease…potentially endangering public safety”.
Erickson pointed out that the guidance released by the FDA – Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency – dictates clear guidance for devices and systems that are used to detect elevated human body temperatures amid the global pandemic.
“Many of our member companies are taking measures to ensure these guidelines are followed, but it has become increasingly clear that there have been some products introduced during this time that are missing the mark when it comes to enhancing public safety,” Erickson wrote.
“These failures come as a result of not following the guidance, specifically when it comes to being labeled consistent with IEC 80601-2-59:2017:
Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening or an alternate standard. Some products are deviating from this standard by being marketed as:
* Able to scan multiple subjects at a time
* Able to scan subjects with an obscured procerus region (hats and glasses)
* Able to scan subjects outdoors
* Able to scan subjects with windows in the background.
“These claims are not supported by the guidelines or standards, and without enforcement of the FDA guidelines, the result has been confusion in the market which can lead to a false sense of public safety.
“The proliferation of solutions that cannot function as marketed also negatively affects makers, resellers and users of solutions that do follow the guidelines.”
Erickson said SIA believes there is an opportunity for the FDA to support the agency’s mission of protecting public health and safety by enforcing the guidelines that were released in April 2020.
In Australia, the TGA categorised all BTM products as being medical testing devices that require certification 6 months ago. It’s understood the products of many manufacturers have applied for certification.
Suppliers and integrators could be forgiven for assuming some of these solutions might have been certified by now but it appears there’s no process of certification and no clarification on whether such a process will be established.
You can take a look at the TGA’s position on BTM solutions here.
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