The FDA communication states: “To date, these systems have not been shown to be effective or accurate when used to take the temperature of multiple people at the same time and should not be used for “mass temperature screening.” The accuracy of these systems depends on careful set-up and operation, as well as proper preparation of the person being evaluated. Customers and health care providers who use thermal imaging systems should be aware of their limitations and the proper and improper use of these systems.
Conor Healy, lead researcher IPVM, a surveillance research group, came in his recent study which is going to be set for publication in the Journal of Biomedical Optics, to the conclusion that the utility of devices as fever screeners is highly questionable, and arguably a risk to public health, because they actively report fevers as normal. He and his team found that seven widely used scanners attempt to compensate for the imprecisions of lower-cost sensors and the unpredictable factors of real-world tests by “normalizing” the readings of people’s temperatures. But that “compensating algorithm,” they argue, severely undermines the devices’ medical usefulness. A feverish person with a core temperature of 100.4 degrees, their research found, could be assessed by the test devices as having a temperature of 98 degrees, well within the healthy range.
Bill Maisel, the chief medical officer and director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said the research identified several systems that “didn’t have the level of accuracy that the FDA would expect”. To read the whole FDA communication, please click the link below.
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