Consulting

FAQS

• What is COVID-19?

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

• What does COVID-19 have to do with Fever Screening?

  On April 16, 2020, the White House and Centers for Disease Control (CDC) came out with “Opening Up America Again“ 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.

• What is 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.

• What is the definition of a fever, and what do fevers have to do with infections in general—and COVID-19 virus in particular?

  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.

• What are the standards for setting-up checkpoints to accomplish fever screening at the entry point of buildings?

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

• What types of checkpoints work best to accomplish Fever Screening at the entry point of buildings, and what does that have to do with thermal infrared imaging?

  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, 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 setpoint 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 will be denied access to the building.

• What, if any ISO standards are cited in the FDA 510(k)?

  The two primary 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.

• If many companies have obtained 510(k) Clearance, which companies have approval specifically 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 complete blackbody system.

  • FLIR Systems, Inc. (FSI)

  Note: Clearance is for imager only.

• If the FDA regulates the marketing and sale of medical devices and adjunctive devices and procedures, and there are only two companies that have obtained FDA clearance for Human Febrile Temperature Screening, why are there hundreds of companies currently selling devices for Fever Screening?

  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 the 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.”

• Why would the FDA relax the standards?

  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 the 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 in order to allow established companies to help meet the demand.
  • We 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.

• If infrared works, why not just get a bunch of temperature guns at Home Depot and let the guards check everyone coming through the gate?

  Here are some good reasons:

  • Issues for your company to consider:
    • This unprofessional method will show everyone that your company is not serious about reducing the risk of infection in your buildings.
    • 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.
  • Technical Issues to consider:
    • 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.

• There has been a lot of confusion about naming the thermal imaging part of fever screening, i.e. skin temperature measuring, elevated body screening, etc. What is a good definition of how thermal imaging is tied to any official terms?

  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.

• Who regulates Fever Screening (Human Febrile Temperature Screening) in the United States?

  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 received a 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)).”

• When will the FDA Enforcement Policy for Telethermographic Systems be reinstituted?

  Again, we do not know, but on the FDA website, there are many references to keeping the current policies until at least the end of the “Public Health Emergency,” which again, from the website, 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.

• What are some of the different types of entry point systems available?

  Below, a table with the different types, flow rates, best uses, advantages, and disadvantages:

  Type System	Maximum Traffic Flow – Best Use	Advantages	Disadvantages
  Spot Radiometers	30/hour Single small operations	Inexpensive.	Very inaccurate and zero documentation.
  Single-Entry Point	30/hour High-security bldgs./small offices	High security but could also be used in small offices.	Must be integrated into the existing security system.
  Kiosks	50/hour Small to medium operations	Looks modern.	Expensive, given what is inside the box.
  Stand Alone IR Camera	100/hour (varies) Small to medium operations	Flexible designs at moderate cost.	Image quality, size, capabilities and documentation is variable.
  High Flow Systems	500/hour Medium to large operations	Higher quality w/100% documentation.	Higher cost and takes staff to operate the system.

• Since our company may be purchasing many thermal infrared systems for the purpose of fever screening and the fact is that this will become a SOP for many companies far into the future—past the emergency period, should we buy only FDA-cleared equipment?

  Here are some considerations you should take before moving forward with any purchases:

  • There are many different types of systems; one size does not fit all, and cheap is not necessarily better.
  • Even the most expensive systems on the market will NOT make much difference at all in the overall cost of your program.
  • Supplies (as of mid-May 2020) for thermal imaging systems of any kind are extremely low. Many companies are estimating 90 days minimum for delivery. So, availability is a huge factor. If you cannot get an imaging system for three months, you should get one that is available now and that you can live with for as long as you need to.

  The bottom line is that the selection of the imaging system is best made for you by a consultant, who will have a better handle on which, how many, and the type of IR imaging systems that will be needed to accomplish the goals that you set in your policy. Considerations are budget, entry points, traffic flows, shift schedules, and other logistical considerations at a single entry point, a particular site, or across the entire corporate inventory of facility stock.