SIA Submits Letter to FDA Addressing Thermal Imaging Systems

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. The letter is available here.

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 security industry companies which had a business or general interest in the technology.

As captured through this group and from direct feedback from members, it was clear 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” [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,” 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 ad hoc group of SIA members also plans to follow up with additional guidance to the industry and the public that aligns with the FDA’s guidelines.

Featured

  • Allegion, Comfort Technologies Implement Mobile Credentials at the Artisan Apartment Homes in Florida

    Artisan Apartment Homes, a luxury apartment complex in Dunedin, Florida, recently transitioned from mechanical keys to electronic locks and centralized system software with support from Allegion US, a leading provider of security solutions, technology and services, and Florida-based Comfort Technologies, which specializes in deploying multifamily access control, IoT devices and software management solutions. Read Now

  • Mall of America Deploys AI-Powered Analytics to Enhance Parking Intelligence

    Mall of America®, the largest shopping and entertainment complex in North America, announced an expansion of its ongoing partnership with Axis Communications to deploy cutting-edge car-counting video analytics across more than a dozen locations. With this expansion, Mall of America (MOA) has boosted operational efficiency, improved safety and security, and enabled more informed decision-making around employee scheduling and streamlining transportation for large events. Read Now

  • Security Industry Association Launches New “askSIA” AI Tool

    The Security Industry Association (SIA) has unveiled a brand-new SIA member benefit – askSIA, a conversational AI agent designed to help users get the most out of their SIA membership, easily access SIA resources and find the latest information on SIA’s training and courses, reports and publications, events, certification offerings and more. SIA members can easily find askSIA by visiting the SIA homepage or looking for the askSIA icon in the top left of webpages. Read Now

    • Industry Events
  • Industry Embraces Mobile Access, Biometrics and AI

    A combination of evolving workplace dynamics, technology innovation and new user expectations is changing how people enter and interact with physical spaces. Access control is at the heart of these changes. Combined with biometrics and AI, mobile access control has become increasingly crucial for deploying entry solutions that are seamless, secure and adaptive to user needs. Read Now

  • Sustainable Video Solution Delivered for Landmark City of London Office Development

    An advanced, end-to-end video solution from IDIS, with a focus on reducing waste and costs, has helped a major office development in the City of London align its security with sustainability objectives. Read Now

New Products

  • QCS7230 System-on-Chip (SoC)

    QCS7230 System-on-Chip (SoC)

    The latest Qualcomm® Vision Intelligence Platform offers next-generation smart camera IoT solutions to improve safety and security across enterprises, cities and spaces. The Vision Intelligence Platform was expanded in March 2022 with the introduction of the QCS7230 System-on-Chip (SoC), which delivers superior artificial intelligence (AI) inferencing at the edge.

  • Connect ONE’s powerful cloud-hosted management platform provides the means to tailor lockdowns and emergency mass notifications throughout a facility – while simultaneously alerting occupants to hazards or next steps, like evacuation.

    Connect ONE®

    Connect ONE’s powerful cloud-hosted management platform provides the means to tailor lockdowns and emergency mass notifications throughout a facility – while simultaneously alerting occupants to hazards or next steps, like evacuation.

  • PE80 Series

    PE80 Series by SARGENT / ED4000/PED5000 Series by Corbin Russwin

    ASSA ABLOY, a global leader in access solutions, has announced the launch of two next generation exit devices from long-standing leaders in the premium exit device market: the PE80 Series by SARGENT and the PED4000/PED5000 Series by Corbin Russwin. These new exit devices boast industry-first features that are specifically designed to provide enhanced safety, security and convenience, setting new standards for exit solutions. The SARGENT PE80 and Corbin Russwin PED4000/PED5000 Series exit devices are engineered to meet the ever-evolving needs of modern buildings. Featuring the high strength, security and durability that ASSA ABLOY is known for, the new exit devices deliver several innovative, industry-first features in addition to elegant design finishes for every opening.