The Security Industry Association (SIA) is asking the Food and Drug Administration (FDA) to enforce its own rules concerning the use of thermal imaging systems. Thermogrpahic scanners can determine whether or not someone is running a fever, making them a popular public safety option for establishments that are looking to prevent the spread of COVID-19.
The request itself was made in a letter sent to FDA Commissioner Stephen Hahn, which noted that many establishments have not been following the proper guidelines since implementing thermographic tech. In that regard, the SIA specifically warned about the prevalence of untested systems that do not perform up to any meaningful standard, and that therefore give a misleading and potentially dangerous view of the general public’s health.
The letter was developed by a volunteer group of SIA members, to represent the interests of established technology providers that develop and sell thermal imaging cameras. It alleges that rival vendors have been marketing solutions that do not function as advertised, especially if they claim to be able to take the temperatures of multiple people at the same time, or to be able to take the temperature of subjects with covered faces. Some vendors have also been telling customers that their thermal cameras are not medical devices, and therefore do not need to adhere to FDA guidelines.
The SIA refutes the latter claim, noting that the thermal scanners are expressly being used to assess the health of patrons. That makes them medical devices by definition, since the FDA defines a medical device as one that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”
Untested solutions also undercut the existing market. Companies that develop thermal imaging solutions for the healthcare industry need to pay for expensive third-party testing to make sure those solutions meet the FDA’s 510(k) standards. Products that do not meet that standard can create a false sense of security if they produce inaccurate thermal readings.
“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.”
Dozens of technology providers have released thermal screening solutions since the start of the pandemic. However, SIA did not disclose the identities of the companies that contributed to the letter, or those of the companies whose bad behavior motivated its creation.
November 10, 2020 – by Eric Weiss