FAQs - Entry Scan IR

SARS-CoV-2 is the novel coronavirus that causes coronavirus disease 2019 (COVID-19).

On April 16, 2020 the White House and Centers for Disease Control (CDC) came out with:

as guidance for US citizens and US companies in three phases to safely reopen the United States. In all three phases, employers are asked to do temperature checks on employees and visitors. This means Fever Screening.

Taking the temperature of humans to make sure they do not have a fever before they enter a building. Officially, it is called Human Febrile Temperature Screening.

Normal core body temperature average is 37°C or 98.6°F. A fever is considered any core temperature above 38°C or 100.4°F. Infections cause the body’s temperature to rise. The most common symptom (found in 99% of symptomatic cases of COVID-19 viral infection) is a fever.

There are no official specific standards for check points, only physical distancing guidance that suggests that everyone be separated by 6 feet and people are screened for fever before entry to the building is granted.

The best is a two-part approach: Primary Fever Screening -using thermal infrared measuring of skin temperatures, and Secondary Fever Screening, using thermometers.

Primary Fever Screening: Since there is a relationship between the internal and external body temperatures of humans, it has been determined that; a) to reduce screening times, and b) to reduce the risk of cross-infection between the incoming person and the screener, that thermal infrared measuring of the skin on the face (specifically the inner canthus of the eye or tear ducts area) has an acceptable level of accuracy and repeatability to be used confidently as a primary screening method of fever screening. So in the primary fever screening process, when people with a skin surface temperature higher than that of a given set point are found by using thermal infrared methods, this apparent elevated body temperature warrants that person should be directed to Secondary Fever screening, using thermometers to determine if they actually do have a fever.
Secondary Fever Screening: This is accomplished by checking the internal temperature of a human being by placing an analog or digital thermometer in the mouth, armpit or rectum. Also, tympanic thermometers (infrared ear thermometers) have gained popularity because they are mostly accurate, more non-contact and faster than other types. If the person has a fever, they are denied access to the building.

Here are a bunch of good reasons:

• First, temperature guns (spot radiometers) are notoriously inaccurate.

• The screener and the person entering the building would have to violate the 6-foot stand-off distance guidance because spot radiometers must be closer than that to read a temperature anywhere near accurately, which risks cross-infection. Also, with respect to the laser on many spot radiometers – the laser is just a guide and does not represent the exact spot or area where the temperature is being taken.

• The screeners would have to be extremely well-trained and would have to execute a perfect procedure every time in order to have any sort of repeatable results.

• The environment where the temperatures are taken would have to be at steady state, meaning that the people and the room where the screening takes place cannot be outside at the gate or in any unconditioned space.

• This is an extremely slow and inaccurate process, especially in a facility any larger than a 20-30 people/hour traffic flows. Imaging systems can handle 400-500 people/hour and document the results.

• Issues for your company:

o This unprofessional method will show that the company is not serious about reducing the risk of infection in their buildings.

o There is ZERO documentation of the temperature of every person screened each day. When an employee sues the company because they were infected with the COVID-19 virus at work, a diligent company will have image records and complete documentation showing that each person passed the fever test on each entry to the building -and the time when they did not and were denied entry. This can only be documented with a thermal infrared imaging system, connected to a computer.

International and US protocols recognize Thermal Infrared Imaging as a valid method of detecting Elevated Body Temperature in humans by using Skin Temperature Measurement which will significantly speed the process of employees and visitors safely entering buildings by using Human Febrile Temperature Screening.

In the United States, the US FDA “clears” medical devices (they do not approve them). As it relates to thermal imaging: if a company wants to market a medical device, the company must obtain, submit, have evaluated and get 510(k) clearance for that device. In the past, many companies have obtained 510(k) Clearance, entitled: ‘Applications for Medical Device Product Code “LHQ” (System, Telethermographic (Adjunctive Use))’.

The main two ISO standards related to the US FDA 510(k) documents are:

ISO/TR 13154:2017 – ‘Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph’.
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’.

Only two companies have FDA Clearance specifically for Human Febrile Temperature Screening for some (not all) of their series and/or models:

Infrared Cameras, Inc. (ICI)

Note: Clearance is for imager, including a blackbody complete system.

FLIR Systems, Inc. (FSI)

Note: Clearance is for imager only

Because on April 16, 2020, the FDA Center for Devices and Radiological Health, Office of Product Evaluation and Quality released a document entitled:

‘Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency’.

The document relaxes FDA regulations on the marketing and sale of Telethermographic Systems for medical use. In the document, the FDA uses words “recommends” and “should” throughout, and not the word “shall”. So, until the FDA withdraws this guidance and goes back to pre-April 16, 2020 standards, all manner of equipment and procedures are available to the public -sort of Carte Blanche to sell any and all “heat thingies”.

Many standards have been relaxed during this “Public Health Emergency” -not just this one. Below, our assumptions, based on much reading about this subject:

We assume that FDA was worried that the existing IR imager stock in the US would not meet demand (that was certainly true).
It would have been too time-consuming and/or too complicated for them to sort through all the documents in a short period of time and figure out how to relax the guidance just a little, in order to allow established companies to help meet the demand.
We like to think, some of the above, but also because they wanted to open the flood gates to stimulate innovation and at the same time introduce competition to drive prices down for the consumers.

But we do not know.

Again, we do not know, but reading on the FDA web site, there are many references to keeping the current policies until at least the end of the “Public Health Emergency”, which again, from the web site, will be at least December 31, 2020. We anticipate that the “New Normal” operations for companies will include fever screenings for months or years to come.