Elevated Body Temperature Screening Process
Infrared Imaging is an approved and recognized method for determining Elevated Body Temperatures. It was used and studied during the SARS virus outbreak in 2003 and then again in the Swine Flu epidemic of 2009 as a method for temperature screening. There is established research and guidelines that cover the use of Infrared Imaging for identifying human febrile (fever) body temperatures.
Deployment, implementation and operational guidelines for using medical equipment for a screening thermograph is covered by ISO/TR 13154:2017. Basic safety and essential performance of screening thermographs under controlled environmental conditions is covered by IEC 80601-2-59:2017. The safe and effective manner for thermographic application and equipment requirements to measure Elevated Body Temperatures is covered by these documents.
Recent advances in IR camera technology has made most of that research dated. The standards and guidelines that provide little instruction on thermography’s use for triage in business settings. Current infrared devices have a greater sensitivity and ability to detect elevated temperature readings. Modern equipment can be more easily integrated with software for a more automated process with digital images and telemetry functions.
Current Telethermography Guidelines
Infrared Cameras and IR Thermometers that are approved for medical use are regulated under 21CFR 884.2980 (a) and have a product label of LHQ. Many of the Non-Contact Infrared Thermometers (NCIT) meet this standard and are used for temperatures taken at the forehead. These devises have a temperature sensitivity of 0.9° F. Some high-end Infrared cameras also meet this standard and are labeled for this use.
The April 2020 FDA Guidelines basically suspend all the prior standards to help meet the needs of this pandemic. These guidelines required a 320 x 240-pixel resolution camera, with a Black body incorporated to help provide an accurate temperature reading.
They also requiring that the face fill over 50% of the screen to meet focal level and spot size criteria. With the suspension of those guidelines, many of the Infrared products coming on the market do not meet any guidelines. Businesses will have to make choices to go with Infrared systems that can meet their immediate needs and may not be compliant if and when those original guidelines are reestablished.