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Liability issue for thermal cameras / register for webinars

June 3, 2020
Title:  selling and installing thermal imaging cameras and liability exposure
When:  June 4, 2020 12 PM EST.
Presented by:  Ken Kirschenbaum,Esq.  Guest panelists: Barry Levine, Pres of Sperry West
Who should attend:  owners, managers, sales people
Title:  Guarantee and hold back issues / valuation in era of coronavirus
When:  June 9, 2020 12 PM EST.
Presented by:  Ken Kirschenbaum,Esq.  Guest panelists:  Mitch Reitman, Rory Russell
Who should attend:  Alarm owners
Liability issue for thermal cameras  
            Thanks for the feedback. I asked you the following question, and your response follows.
            Q. "can the alarm industry install these cameras now, even though they are not FDA approved?  A. Seems to me the answer is yes - in non-medical facilities, like the airport."
            I don't think we disagree on this fundamentally. They "can" install them. But how the device is marketed or operated could have an impact on liability. We asked the FDA about this here
            Here is the FDA's full statement in which I've highlighted a few sections that I believe are relevant:
            The FDA recognizes the increased interest in telethermographic systems during the COVID-19 pandemic. We provided an update to our website to help users and the public understand the benefits and limitations of these devices, and their role during the public health emergency. The update helps explain how to correctly use these devices to accurately measure someone’s temperature and clarifies questions around different environments in which these devices could be used. This information should be used in conjunction with the guidance issued in April.
            This guidance does not change existing regulations or requirements; instead, it announces that the FDA does not intend to object, under the circumstances described in the guidance and where such use does not create undue risk, to the distribution and use of certain devices without compliance with certain regulations and requirements, in order to help protect public health during this emergency.
            As the agency always does, if the FDA receives information that a manufacturer is marketing a medical device in violation of regulations, the FDA prioritizes review of such action based on risk to public health and available resources. If the FDA receives information that indicates manufacturers are marketing thermography devices in ways that pose risks to public health, the same principles would apply to the review of that information.
            Our understanding of the FDA's statement here is that if companies use any of these devices (FDA 'approved' or not), in ways that run counter to FDA guidance, they expose themselves to regulatory and legal risk. 
            For example, the FDA says that only one person should be screened at a time and there should be no face obstructions when screening a person. Yet countless US companies are both marketing and implementing systems that run counter to what the FDA says. And I will add, IPVM's testing results concur with the importance of those things for accurate screening.
            My question to you is: Granting that we agree that they can be installed currently, what risk or responsibility do you believe alarm companies have if they market or operate them counter to FDA guidance?
John Honovich
            We have a webinar on this topic on June 4.  I hope you attend and participate.
            There have been several articles over the past few days devoted to the thermal imaging devices.  I am beginning to wonder how many companies [alarm, integrator, et al] are actually selling and installing these devices.  It's not that they are concerned with liability or regulatory issues, it's that they haven't had any request.
            There is no doubt that you can sell and install the devices.  Because it's something different than what alarm companies routinely sell, install and monitor [fire, intrusion, video cameras, etc] the Standard Form Commercial All in One has been updated to include these devices.  The devices are described, in particular what they should not be used for, and liability provisions have been updated to include these devices.  The Commercial All in One will provide the best contractual protection when you sell the thermal imaging devices, especially in non-medical settings, such as a hospital or medical facility where Covid-19 testing is performed and the thermal imaging device is used by medical professionals for diagnostic purposes.  Can they?  Yes, if the device is FDA approved.  I have no idea if any such devices have been FDA approved.
            During the pandemic the devices can be sold and installed in non-medical settings and devices not approved by FDA can be installed.
            The question poses is what liability does the alarm company have if it markets or operates the devices "counter to FDA guidance"?  The question compels the answer, potential for liability would be increased.  But isn't that the same answer for alarm companies installing any life safety devices?  The alarm industry recognizes AHJ authority over systems and equipment and understands that risk for liability is increased if established guidelines are not followed.  Thermal imaging devices are no different.  If the FDA is the AHJ [and I assume it is] then its guidelines establish what should be manufacturer suggested guidelines and custom and practice in the industry.  
            Companies who intentionally market the devices for use in a way that is contradicted by the contract terms risk increased liability; same for disregarding installation procedures.  If an alarm company provides a service using the devices after installation [and the Commercial All in One does not provide for that, though it can be provided in the Schedule of Equipment and Services] then adherence to AHJ requirements [or even suggestions] increases exposure.
            The Commercial All in One is designed to protect against breach of contract and negligence; no contract will likely shield you for gross negligence and willful misconduct or intentional acts which you know or should know are likely to cause injury to another.  If you get the Commercial All in One and market and install the devices in accordance with the contract terms you should reduce or limit, if not eliminate, liability.

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Ken Kirschenbaum,Esq
Kirschenbaum & Kirschenbaum PC
Attorneys at Law
200 Garden City Plaza
Garden City, NY 11530
516 747 6700 x 301