FDA Guidance On Fever Detection
Using Infrared Thermal
Athena Meets Or Exceeds The April 2020 FDA Guidance On Elevated Human Body Temperature Detection
The FDA has issued guidance on infrared thermal elevated human body temperature detection. Athena is proud to announce that we meet or exceed the device specifications. including the same recommendations as Athena:
*Heat Source Reference Point, aka Blackbody, is necessary.
*Must be highly accurate infrared thermal sensor, better than +-.5°C
*0.2°C or less Drift
*One person at a time. No groups.
*Adjunct to a holistic approach. Athena’s System should be used for fast triage. And those alerted to have an elevated temperature should then be checked with an FDA approved medical thermometer.
*And more guidance including labeling, calibration,
“Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”:
The FDA is “issuing this guidance to provide a policy to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.”
An Elevated Body Temperature Detection System like Athena’s is simply for the initial triage.
"FDA believes such telethermographic devices will not create such an undue risk when the following circumstances related to the performance of the device and the transparency and clarity of information in the product labeling are present."
And the FDA goes on to give specific recommendations on characteristics of the device. Athena is proud to meet or exceed:
1) Is tested and labeled consistent with the following standard: 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
2) Is tested using alternative performance specifications that provide similar results to IEC 80601-2-59:2017. This could include:
a) The laboratory temperature accuracy of a screening telethermographic system, including the measurement uncertainty, is less than or equal to ±0.5°C (±0.9°F) over the temperature range of at least 34-39°C (93.2-102.2°F);
b) The system includes an accurate blackbody temperature reference source;
c) Both stability and drift are less than 0.2°C (0.36°F) within a timeframe specified by the manufacturer; and
d) The device risk assessment addresses all potential safety issues, including:
- i) Electrical safety;
- ii) Electromagnetic compatibility;
- iii) Mechanical safety;
- iv) Excessive temperatures and other hazards;
- v) Accuracy of controls, instruments, and information display;
- vi) Considerations for software associated with Programmable Electrical Medical Systems including network connections; and