SIA recently submitted a letter to the Food and Drug Administration (FDA) commissioner Stephen Hahn with a focus on an awareness that some companies are not following FDA guidelines related to the use of thermal imaging systems during the COVID-19 pandemic. The letter also encouraged the enforcement of FDA’s guidelines.
According to SIA, the organization received reports from member companies and had dialogue with those members who shared with additional information, and it became clear this was an issue, which was further reinforced by SIA’s thermal camera ad hoc working group discussions on this issue.
“SIA had been concerned about the potential misuse of this technology by some companies that had offerings that seemed out of line with the FDA guidance, particularly after the detailed May 13 guidance,” the organization said.
SIA developed and issued the letter in October with input from an ad hoc group of SIA members who responded to a call for volunteers. The ad hoc group represents producers and resellers of thermal camera systems in addition to other security industry companies which had a business or general interest in the technology.
As captured through this group and from direct feedback from members, many SIA members were concerned with thermographic camera systems for a variety of reasons. Some of these concerns that were voiced included:
- Many companies have spent extensive resources on research and development testing their solutions against standards so that they can be used as a medical device. This included third-party testing and or the FDA’s 510(k) clearance process. Companies were concerned that tested products were being undercut by untested (and thus less expensive) products.
- There were media reports of a number of products that did not work as marketed — particularly claims related to detecting temperatures of multiple subjects at a time, including while those multiple subjects were in motion, and claims that solutions were able to return accurate body/surface temperatures when the procerus region (the area around the bridge of the nose and corners of the eyes) was covered.
- There were also reports of vendors and resellers claiming that their thermographic camera solutions are not medical devices and are therefore not subject to FDA guidelines. The group noted that there appears to be confusion as to what constitutes a medical device. The FDA’s definition of a medical device includes thermographic cameras that screen for temperature — or plainly any device that 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.”
The input from members was that there are products being installed with the intention of disease management and mitigation, and that management and mitigation ultimately do not occur, because some of the products are unable to work as advertised, and this then leads to a false sense of safety.
“SIA believes it is extremely important that these thermographic solutions are marketed appropriately and implemented in line with the FDA’s guidelines,” said SIA CEO Don Erickson. “Circumventing the implementation guidelines can lead to market confusion and create a false sense of public safety related to the mitigation of the COVID-19 pandemic.”
The SIA thermal camera ad hoc working group will continue to work on this guidance.
“SIA has produced webinars and informational articles on this topic in the past, and plans to continue providing informational resources on this topic, particularly with the intention of helping to educate the public and any firms installing these solutions,” it said.
SIA says there is no specific count for the number of companies and solutions that are not following FDA guidelines.
“Enforcement of FDA’s guidelines is managed by the FDA and our letter encourages enforcement, however SIA also has an ethics policy for its members,” it said.
The letter is available here.