301.519.9237 exdirector@nesaus.org
SIA recently sent a letter to the FDA expressing concerns about companies offering temperature screening solutions that are not following the agency’s guidelines.
(Photo courtesy Milkos/bigstockphoto.com)

11.4.20 – SIW – Link to Story

Association calls on agency to enforce its own guidelines regarding solutions that miss the mark

The Security Industry Association (SIA) on Wednesday announced that it recently sent a letter to the U.S. Food and Drug Administration expressing concerns about companies offering temperature screening solutions that are not following the agency’s guidelines and thus endangering public safety with regards to the spread of COVID-19 while also harming the reputation of reputable vendors.

In the letter, SIA points to guidance issued by the FDA that spells out the requirements for systems used to detect elevated human body temperatures during the pandemic and calls upon the agency to enforce them.

“Many of our member companies are taking measures to ensure these guidelines are followed, but it has become increasingly clear that there have been some products introduced during this time that are missing the mark when it comes to enhancing public safety,” SIA CEO Don Erickson wrote in the letter.

SIA said it developed and issued the letter 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 security industry companies which had a business or general interest in the technology.

As a result of direct feedback from members as well as that generated by the group, SIA said it was apparent that members were concerned with thermographic camera systems for a variety of reasons, including:

  • 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” [emphasis added by SIA].
  • 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,” Erickson said in a statement. “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.”