United States. Don Erickson, CEO of the Safety Industry Association (SIA), recently sent a letter to Food and Drug Administration (FDA) Commissioner Stephen Hahn with a focus on 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 application of FDA guidelines.
The 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 represented established producers and resellers of thermal camera systems, in addition to other companies in the security industry that had a commercial or general interest in the technology.
As captured through this group and direct feedback from members, it was clear that many SIA members were concerned about thermal imaging camera systems for a variety of reasons. Some of these concerns that were expressed were:
- Many companies have invested extensive resources in research and development to test their solutions with standards so that they can be used as medical devices. This included third-party testing or the FDA's 510(k) authorization process. Companies were concerned that tested products were being undervalued by untested (and therefore less expensive) products.
- There were reports about a number of products that did not work as marketed, in particular claims related to temperature detection of several subjects at once, even while those multiple subjects were on the move, and claims that the solutions were able to return a 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 from vendors and resellers claiming that their thermal imaging camera solutions are not medical devices and therefore not subject to FDA guidelines. The group noted that there appears to be confusion about what constitutes a medical device. The FDA's definition of a medical device includes thermal imaging cameras that detect temperature, or simply any device that is "intended to be used in the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals" [emphasis added by SIA].
The opinion of the members was that products are being installed with the intention of managing and mitigating diseases, and that management and mitigation ultimately do not happen, because some of the products cannot work as advertised, and this leads to a false sense of security.
"SIA believes it is extremely important that these thermographic solutions are properly marketed and implemented in accordance with FDA guidelines," said SIA Executive Director Don Erickson. "Circumventing implementation guidelines can lead to market confusion and create a false sense of public safety related to mitigating the Covid-19 pandemic."
The ad hoc group of SIA members also plans to follow up with additional guidance for industry and the public that aligns with FDA guidelines.
See the full report here.
