Temperature Screening Kiosks That Stack Up Against FDA Requirements

zortemp 1000 temperature scanner

Zortemp 1000 Body Temperature Scanner

Zortemp 600 Infrared Temperature Reader

Zorpro 6T Temperature Walk Through Detector

There are a few aspects of life that have become such a norm we rarely think about a future life without them. Although the measures being taken for public safety vary across the nation, the most common are mask-wearing and symptom- and/or temperature-screening. 

Studies have proven that commercial and academic communities drastically decrease the number of staff or students contracting the virus when adequate screening measures are in place. 

If you want to be certain that any potential carriers are barred from your facility, you should have a comprehensive upon-entry contactless screening system that includes:

  • Temperature scanning, where anyone with a surface skin temperature of 99 degrees or higher must seek further diagnosis, with a negative covid test result prior to returning to the facility.
  • Screening questions upon arrival, which may vary based on the organization and locale, but generally involve questions regarding potential symptoms or exposure.

But you probably don’t need convincing about the need for temperature screening at your facility if you are already reading this article. The question racing through the minds of most consumers is, “How do I tell these temperature screening kiosks apart?”

Searching for a reliable, facts based, quality tested temperature screening device brings up dozens of pages of links to manufacturers, suppliers, and wholesalers. The pandemic has, of course, made these devices in high demand. Features and price ranges can vary widely, so it is important to know what you are looking for before you commit to a purchase.

One of the ways people generally find reliable medical devices, such as temperature taking instruments, is to look for FDA approved devices. But due to the pandemic, there are many thermographic temperature screening kiosks that meet guidelines without that official stamp of approval. 

The bottom line? Any legitimate temperature scanning device currently on the market is within FDA guidelines, even if they do not have “FDA Approval.” This article will explain why the distinction is important, how we stack up against the competition, and evidence of how our Zortemp 1000 is FDA compliant according to pandemic guidelines. 

Technical Specifications for Thermography Medical Devices

Standards in technical specifications for thermography medical devices are still being developed, but there are some standards required for any temperature screening kiosks sold commercially. These devices must be accurate within a certain range, and they must be tested for quality to ensure that guarantee of accuracy. Manufacturers of these temperature scanning kiosks must also comply with certain testing and quality assurance policies, even though they are not getting FDA approval prior to going to market.

While the FDA has greatly relaxed the registration and listing requirements to get as many of these temperature screening kiosks on the market as possible, all of these screening tools must meet some basic standards. It would be irresponsible for it not to be so, considering a false sense of security can often be the downfall of public health.

All thermographic temperature scanners should follow these minimum technical guidelines:

  • Temperature accuracy within 0.9 degrees Fahrenheit
  • The accurately instructed use of blackbody temperature scanning
  • Electrical and mechanical safety measures standard for similar medical devices
  • Labeling requirements to ensure temperature reading accuracy in on-site applications

An examination of the features and specifications of our body temperature scanners show that our product meets or exceeds these guidelines with the following features:

  • Skin body temperature reading accuracy of up to 0.5 degrees Farenheit
  • Recommended use of a blackbody (background) for more accurate temperature scanning of one individual at a time.
  • Meets all electrical and mechanical safety standards and labeling requirements

In addition, our products share these accuracy-driven characteristics with the currently FDA approved kiosks:

  • Utilizing infrared optical sensors as opposed to thermographic camera technology
  • Dedicated signal processors to block infrared noise that could interfere with the reading
  • Embedded sensors at appropriate heights for readings of all heights, with an emphasis on forehead scanning when possible.

So, you can easily see that our Zortemp 1000 is on par with the other temperature screening devices on the market, even the ones developed prior to the pandemic. Our infrared temperature scanning technology is equal to that of even those of competitors with the FDA stamp of approval.

Zortemp 1000 Temperature Screening Kiosks Meet Market Expectations

There are two primary types of temperature screening kiosks found all over the global market today—those that utilize a camera to locate and scan the exact forehead of the subject, and those that use infrared sensors to detect surface temperature. The infrared sensors that our product is built around have often been found to be more accurate, and it is the technology utilized in similar FDA approved devices. 

Infrared temperature screening kiosks have several advantages, including:

  • Higher accuracy in surface temperature readings
  • Extends the radius of the temperature scan to encourage distancing
  • Alay privacy concerns due to the use of cameras to scan faces
  • The entire screening process takes seconds, keeping it efficient at one subject per screening

The Zortemp 1000 is better than many other temperature scanning kiosks available commercially, keeping your staff, students, and/or guests safe on-site with accurate readings. Part of that means that we ensure those utilizing our product do so as it was intended for the success of the program. 

We also know that we have a responsibility to those facilities using the Zortemp 1000 to be realistic in its capabilities. While our kiosk has a temperature sensor at about wrist level, it is more designed for use with children or disabled whose foreheads would not reach the kiosk’s recommended height.

Finally, like many other thermographic temperature scanners on the market, we offer AI software that integrates with your kiosk to allow for a complete self-service experience that still gives you and your staff a modicum of security. Unlike our competitors, our software is simple to implement and monitor, with an intuitive user interface.

Of course, every product has its downsides. Some studies would argue that temperature scanning kiosks are not accurate when they are not able to detect the forehead. It is true that the forehead is the most accurate part of the body to scan. 

However, the feedback from our clients is overwhelmingly in favor of infrared over cameras with face detection. Those with privacy concerns about “Big Brother” watching do not like the idea of face detecting, and therefore scanning, software. And, since this is only a screening tool and a more accurate temperature reading is called for, our temperature kiosk is still a worthwhile screening tool.

Temporary Pandemic FDA Guidelines for Temperature Scanners

Under normal circumstances, medical device developers and/or manufacturers must file certain paperwork to have their device approved by the FDA, even if it is just for measuring the surface temperature of the skin to determine if additional screening is necessary. But the FDA recognizes the need for these temperature screening devices, and as such they have relaxed the rules somewhat.

This means that a contactless temperature kiosk such as ours can be FDA compliant without having that FDA Approved rubber stamp. When the crisis dies down and business can resume as usual, there will be a rash of approved medical devices on the market. That all being said we don’t officially claim our devices to be for “medical use”. 

Even though the FDA has suspended some of the requirements for approval (mostly what the average person considers the “red tape”), temperature screening kiosks are still legally required to meet certain pandemic guidelines in order to be FDA compliant. Any products out of compliance are being marketed illegally, but that doesn’t mean you can assume that all are adequate.

Here are some of the FDA guidelines that are currently in place to protect consumers against illegitimate or inaccurate temperature scanners.

Meets testing requirements and performance specifications

Just because some of the red tape has been cut out, doesn’t mean our products don’t have to meet certain specifications. In order to be considered safe for public use, these medical devices must meet the following minimum testing requirements:

Temperature Accuracy Testing

Any thermographic temperature scanning medical device must be accurate to a minimum of 0.9 degrees Fahrenheit within a temperature range of 93.2 to 102.2 degrees. This ensures that anyone with a questionable temperature is further screened for possible infection. If a blackbody is required to obtain an accurate temperature reading, as will most infrared devices, this must be prominent in the product’s labeling and instruction manual.

Device and related software risk, security, and safety assessments

It is still a requirement for companies to ensure that their products are safe for public consumption. All medical devices must meet certain standards for electrical and mechanical safety. Temperature scanners must have accurate controls and instruments as well, with an easy to understand information display.

When software will be used with a temperature scanner to improve screening accuracy and completeness, as well as mitigating outbreaks in your facility, you should ensure that software has undergone rigorous testing. Our software, although a seemingly bare bones application, is above par in the areas of usability and security of personnel information.

Tested using alternative performance specifications

Many of the temperature scanners being marketed for use in company entryways aren’t designed for this purpose. Many of these devices were developed to discern temperatures in industry or other commercial applications. Although they have been modified to measure skin surface temperature, that doesn’t mean they are accurate to do so automatically.

This is where alternative performance specifications come into play. The temperature scanning kiosks you install in your facility should have been painstakingly tested in different performance situations to ensure its accuracy in different applications.

Labeling requirements

How will the FDA hold manufacturers liable with relaxed reporting and registration requirements? By enforcing labeling requirements. We at Zorpro believe in being 100 percent honest with our customers and partners, which means we meet and exceed these labeling and instruction requirements.

For any thermal temperature scanner being marketed during the pandemic without FDA approval must include specific, accurate labeling to be within compliance:

  • Prominent notice that an elevated temperature scan cannot be used to diagnose covid or other illnesses, and should be backed up with secondary evaluation
  • Prominent notice that the device is only designed to measure the temperature of one subject at a time, even if the second subject is a child
  • Note the differences in design and indications when compared to FDA approved models (Our model works essentially the same as the FDA approved model, excluding some features.)
  • Prominent notice that the device has not yet been FDA approved, but can state that the product meets the current requirements of the FDA per temporary covid guidelines relating to temperature scanners.

Of course, all other normal FDA labeling still applies, such as including all device performance specifications, simplified  easy to read instructions for its use, description of the blackbody reference source and body site used for temperature readings, and how environmental conditions can alter the accuracy of the device. Instructions must also include installation process, appropriate viewing angle, and other specifications necessary for accurate use.

Our Zortemp 1000 temperature screening kiosks come with detailed, clear instructions in its installation and use. With proper set up and integration of our proprietary software, you should be able to protect your facility with little physical interaction with the system.

FDA Reporting and Listing Requirements Being Waived Due to the Pandemic

These FDA rules are normally required when a device goes from commercial use to medical use, but are being waived due to the pandemic. These rules have been waived in the interest of speeding up the process of getting these temperature scanners installed in facilities across the nation. The more organizations and agencies utilizing temperature scanners and other screening measures, the closer we will be to combating this virus.

These reporting and listing requirements are necessary for a medical device to receive FDA approval. In fact, all legitimate temperature scanners on the market meet FDA guidelines for accuracy and technology, but most are not FDA approved because they were adapted to this use after the pandemic was well underway.

Still, understanding what rules have been sidetracked will help you understand that they have little to do with the accurate use of our temperature scanners.

Premarket Notification

Generally when a company wants to market a medical device to consumers, they must issue a premarket notification. This notification statement alerts the FDA to the fact that they are going to be marketing a Class II or Class III device (those categories under which most temperature scanners fall). As long as there are no objections to testing or quality and accuracy reports, the product can usually move into public consumption.

In reality, this requirement exists simply to alert the FDA to the production of a new medical device created for the purpose, in this case temperature scanning.

Reports of corrections and removals

These reports are normally required when moving a device from commercial to medical use. This is very important right now, because many of these temperature scanners are being adapted from other purposes. Normally those changes and adaptations would have to be approved by the FDA, but for now this requirement has been waived to speed up the process.

There are also some quality system regulation guidelines that normally govern thermometers and other temperature scanning devices. These quality guidelines are still required of the devices, and our Zortemp 1000 meets those specifications. It is only the reporting that has been suspended.

But What Does It All Mean? Is the Zortemp 1000 FDA compliant?

In short, all of this mumbo jumbo really means is that the FDA has bigger fish to fry right now than monitoring the manufacture and distribution of temperature scanning kiosks. But that doesn’t mean the rules don’t apply. If you run into a temperature scanner that is being marketed as accurate without the required labeling and testing requirements, they can still be held liable in court for violating FDA recommendations.

And, it is accurate to say that the Zortemp 1000 is FDA compliant. We ensure that all required labelling, as well as additional information we feel is important to our customers, is well above par to the temporary pandemic requirements of the FDA for thermographic temperature scanners. Our scanners are accurate and use the same technology as FDA approved scanners in the same category.

Still, some people see the notice that something is not FDA approved, and automatically assume that a product does not have merit. This is simply not the case with thermographic temperature screening in our current pandemic world. When things die down and bureaucracy returns to normal levels of operation, more and more temperature scanners will receive that stamp of approval.

To allay some of your concerns, here are some commonly asked questions and their answers.

What kind of technology do FDA approved contactless temperature scanners use?

The only temperature scanning kiosk to be developed and FDA approved prior to the pandemic utilizes our same infrared sensor technology. In fact, our products are very similar, but we strive to make ours more simple and user-friendly to operate, both mechanically and with the integrated software. Other temperature scanners use thermographic imaging with cameras, which have been found to be less accurate.

Would your product pass FDA certification if it were necessary?

The Zortemp 1000 meets all of the same performance specifications as the similar FDA approved version of temperature scanning kiosks. It also utilizes similar technology, with some improvements made to eliminate user error to increase accuracy of screenings. Even the intuitive, user-friendly integrated software can be easily used by any staff member.

Does the Zortemp 1000 meet all current FDA guidelines for temperature scanning devices?

Absolutely! We are 100% compliant with FDA requirements as to technical specifications, performance specifications, and labeling requirements. It is our number one responsibility to ensure that our products are being used responsibly and accurately in the interest of public health.