UPDATE: The content under “Food and Drug Administration” was updated on April 20, 2020, to reflect new guidance from the FDA. See “UPDATE TO FDA GUIDANCE” section.
With the ongoing challenges surrounding COVID-19, we – along with the rest of the security industry – continue to see an influx in demand in human temperature detection devices.
Many organizations are deploying or seeking to deploy these devices for an extra layer of screening and detection for their facility. In these cases, the technology – which uses thermal imaging sensors – is intended to detect elevated temperatures of people entering a facility.
Like many other security providers, we’re in the process of understanding and determining what these devices can and can’t do, what they should and shouldn’t be used for and how they may potentially complement an organization’s broader safety and security plan.
As we continue to research potential applications for human temperature detection, we wanted to share with you some considerations that you may need to take into account when investing in this technology.
Compliance with Appropriate Regulatory Bodies
Some organizations deploying human temperature detection devices may not be aware that there are certain standards and regulations in place that govern this technology.
As your facility is considering implementing it, be sure you understand the implications and potential restrictions you might face, and how that may impact your organization in the short and long term. To start, here are some of the standards, regulatory bodies and laws that could affect your implementation and that you should familiarize yourself with:
International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) Guidance
IEC 80601-2-59:2017 governs the “particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening.” As a complement to the IEC standard, the ISO implemented ISO/TR 13154:2017. This standard provides guidelines for the implementation of thermographs “to minimize the spread of infectious diseases”. The ISO standard provides guidance on the process for deploying solutions that measure febrile conditions of humans, specifically in relation to slowing the spread of diseases such as COVID-19.
Food and Drug Administration (FDA)
Among other things, the FDA regulates medical devices. To determine whether a product is a medical device, the question turns largely on the “intended use” of the product. In regard to a thermal camera, the question largely is whether the camera is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals”. 21 U.S. Code § 321(h)(2)
If a device is considered a medical device by the FDA, there are different types of FDA submissions and approvals that can be required prior to marketing the device, such as a “premarket approval” or the less stringent “510(k) premarket notification”. Some thermal camera manufacturers are taking the position that their devices are not medical devices because they are not intended for the diagnosis of medical conditions, but rather are simply to screen entrants to buildings on the basis of elevated temperature. Other manufacturers, however, have already obtained 510(k) approvals for using the cameras in conjunction with FDA-approved thermometers.
UPDATE TO FDA GUIDANCE (4/20/20)
The FDA has now issued an “Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”.
In it, the FDA noted that generally, manufacturers of systems “intended for adjunctive diagnostic screening” would be required to file a 510(k) premarket notification. However, it goes on to indicate that in light of the public health crisis, “FDA does not intend to object to the distribution and use of telethermographic systems intended for initial body temperature assessment for triage use” for failure of such systems to comply with various regulatory requirements, so long as the devices “do not create an undue risk ” (emphasis added).
The guidance sets forth what the FDA believes would make a device not present an undue risk, which includes both performance and labeling requirements as well as the requirement that the thermographic system be used in conjunction with a confirming secondary evaluation method (i.e., either a non-contact or contact thermometer).
Notable among the labeling recommendations: “The technology should be used to measure only one subject’s temperature at a time.” Thus, it appears that choke-point scanners that scan one person at a time are in line with the FDA’s recommendation, whereas mass scanners that scan multiple people at once are not recommended.
It is important to note that the FDA guidance is just that – guidance : “It does not establish any rights for any person and is not binding on the FDA or the public.” Further, the “policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS.” As such, while the FDA appears to be relaxing its enforcement and standards during the COVID-19 crisis, companies seeking to implement thermal temperature scanning for the long term should be aware that compliance with various regulatory requirements may be required at a later date.
The Americans with Disabilities Act (ADA) and Other Privacy Laws
As businesses have begun to screen their employees for body temperature, some may question whether doing so is an allowable practice. The EEOC has issued guidance that “employers may measure employees’ body temperature” in regard to the COVID-19 crisis. However, it is important to be aware that there may be privacy concerns related to collecting a person’s body temperature, whether that person is an employee or not. The EEOC has noted that “the fact that an employee had a fever or other symptoms would be subject to ADA confidentiality requirements.”
Further, you will need to make sure you’re complying with appropriate regulations like GDPR, HIPAA and other local and regional data privacy regulations regarding personally identifiable information. You may need to obtain consent, provide disclosures about what you’re doing with that information or how it’s stored; requirements could vary based on where you are located.
National Defense Authorization Act (NDAA)
Just as you exercise your due diligence with the ADA, GDPR and HIPAA, you may also need to consider whether you need a product that is NDAA-compliant. If you are a government agency or government contractor, this is a particularly sensitive concern.
What Thermal Cameras Can and Cannot Do
There is no thermal camera that can diagnose COVID-19. Thermal cameras can detect human temperature with varying degrees of accuracy, with some being accurate to within (or less than) 1° F. Related software can allow notifications or alarms to be issued in the event a person’s temperature exceeds a set threshold such as 100.4° F – the CDC’s definition of a fever – which can allow security personnel to decide if additional action is necessary. Further, it is important to note that someone infected with COVID-19 can spread the disease without having symptoms such as a fever.
Keeping an Eye Toward the Future
Much like the approach to cyber threats within business environments, this is about reducing risk and mitigating as much as possible. There is not one single solution you can implement to solve today’s challenges; you must follow guidelines, build a process, define procedures and train resources to manage and follow those procedures and processes.
Thermal imaging sensors are not intended to diagnose COVID-19 or any other medical disease or virus affecting personnel or visitors. They are solely to detect temperature beyond a specified range or threshold and engage the individual by following a clearly defined company process that aligns with the aforementioned standards and regulatory requirements.
As such, this technology may be one of many solutions that your organization is considering in the context of your broader safety and security plan. It may potentially complement existing security solutions or provide your organization with an additional screening approach; however, it’s important that it be considered as part of a holistic security program, not a complete solution in and of itself that will safeguard your organization.
Although demand for human temperature detection devices has exploded as a result of increased concerns around COVID-19, this technology can serve a broader purpose in the future as organizations rethink their visitor management, access control and screening procedures.
If you’re considering investing in this technology, keep an eye toward the future and consider how it can be part of a long-term strategy, as opposed to a short-term solution.