KEN KIRSCHENBAUM, ESQ
ALARM - SECURITY INDUSTRY LEGAL EMAIL NEWSLETTER / THE ALARM EXCHANGE
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Contract update for Thermal Imaging and can you install these devices
May 27, 2020
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Contract update for Thermal Imaging and can you install these devices
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Ever step on a hornet’s nest? In the alarm industry we don’t have enough to worry about with licensing agencies, consumer affairs and attorney generals, unscrupulous competitors, employment issues, corporate issues, insurance companies, lawyers, accountants and lawsuits; now we have to worry about the Federal Drug Administration? Apparently yes. How did I get involved with this mess?
John from IPMV refers the topic of thermal imaging to me. Mike, an insurance broker [not listed on The Alarm Exchange] suggests that alarm contracts be updated to deal with coronavirus issues. So in my article on May 21, 2020 I conclude you could and should sell thermal imaging devices [cameras that detect high fever and more, like check for masks and count number of people coming and going, and probably more by the time you read this article]. That results in an email from an ADT VP and house counsel, who prefers to remain unnamed and doesn’t want her email circulated, who concludes, essentially, that FDA approval is required to sell and install these devices. According to ADT’s website, ADT is using FDA approved devices, as ADT is “… focused on bringing the best, FDA-cleared products to our customers”. Then I get an email from another IPVM reporter who wants to set the record straight. His email, and follow up email is below. Make what you will of it.
Here is my current conclusion. Commercial customers are asking for the thermal imaging devices and alarm companies are installing the devices. These devices are apparently available from different manufacturers. I don’t know if all or any of these manufacturers have requested or obtained FDA approval. The devices should indicate on them if they are FDA approved. Apparently, FDA does not make a distinction between medical grade and non-medical grade thermal imaging devices; any of these devices require FDA approval whether installed in medical or non-medical facilities, whether intended for medical or non-medical purposes.
But these devices are being requested now in response to the pandemic; customers want them now. We have read the latest FDA directive. I agree it states that thermal detection devices need to be cleared by the FDA. The exception is when used for industrial / construction purposes. If it is intended to screen a person’s temperature then it must be cleared through the FDA 510(k) process. The FDA 510k(k) process requires companies to submit its plan to sell the product at least 90 days before marketing it to the public. But the FDA will not object to these devices being distributed unless it “creates an undue risk in light of the public health emergency”.
So where does that leave the alarm industry, who may be asked by customers to install these fever detection devices? I am sticking with my original recommendation: sell and install the devices. The Standard Form Commercial All in One has been updated in several ways to deal with this new service. It’s made clear that the devices are not necessarily FDA approved or medical grade. The devices are not intended for medical purposes, treatment or cure. The alarm company will assume no liability for the accuracy of the device or the consequences if the device fails to detect, or prevent, whatever the end user installed it for. [this is not the language in the contract, by the way, but the gist of it.]
The change to the Commercial All in One will also be useful to insulate against claims alleging virus contamination from your employees. Sounds a little much, but just wait. Look, if you can get FDA approved devices, that’s great. If you want to submit an application for FDA approval before selling the devices, that’s great. With any luck this pandemic will be over before the 90 day approval period and no one will want the devices anymore. Years from now alarm owners will want to know why the provisions are in the contract in the first place.
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Ken,
This is Charles Rollet. I'm a reporter for IPVM.com and have been covering the FDA's fever-detection camera policies since the outbreak of COVID-19.
We have some concerns about your analysis of fever camera regulations and the FDA's policies. You state " th e quick answer is, yes, sell and install these cameras in non-medical settings. Unless you are contracting with a hospital or other medical facility you are not selling or installing medical grade devices intended for diagnostic or cure purposes. [emphasis added]". However, this is not accurate, per the FDA's new guidance itself and our own correspondence with the FDA.
There is no legal distinction between setting up fever cameras in "non-medical settings" vs. medical ones. I think you misinterpreted a passage in the new guidance, which states that industrial thermal cameras "may be marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications."
However, this passage is not referring to fever cameras, but to industrial thermal cameras i.e. the kind used for detecting fires at an electrical substation. Fever cameras are definitely considered medical devices by the FDA, regardless of where they are used. This is explicitly stated in the new FDA guidance:
telethermographic systems fall within the definition of a [medical] device when they are intended for a medical purpose
telethermographic systems are [medical] devices when they are intended for a medical purpose, such as measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body
The FDA itself confirmed to IPVM that fever-detecting cameras are considered medical devices subject to 510(k) clearance; the new guidance temporarily lifts this requirement but says nothing about fever cameras not being considered "medical grade devices" if they're installed in a supermarket or any other "non-medical setting", as your analysis states.
A final point: your citation of the FDA language "intended for diagnostic or cure purposes" is not accurate. This language is specifically used by the FDA to mean that fever cameras cannot diagnose someone with a disease or a fever, it can only detect "an elevated body temperature measurement" which is "confirmed in the context of use with secondary evaluation methods" such as a clinical thermometer.
Since your analysis thanks IPVM, we are concerned this will mislead your readers into thinking we endorse and agree with your analysis, which we consider incorrect. This is of concern to us especially since there is already significant misinformation about what fever cameras can and cannot do.
We are reaching out to you as we are writing an article about your analysis and why we don't endorse its views. We wanted to ask:
Will you be issuing a retraction/update to your readers about your analysis, given our clarifications above?
We also noticed you did not mention the FDA's new guidance in your initial analysis - was this also an error?
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Thanks for your reply. No, we are not suggesting alarm companies cannot install fever cameras - as we see it, what the FDA did in its new guidance was basically to allow manufacturers/integrators/etc to sell fever cameras (regardless of the location of end use) without getting 510k clearance beforehand. Put simply, 510k clearance for fever cameras is temporarily no longer required, due to the pandemic. We wrote an article elaborating this, see here: https://ipvm.com/reports/fda-new
What we take issue with in your analysis is that there is some kind of distinction between fever cams in 'non-medical settings' versus elsewhere (like hospitals, clinics, etc) - having read the FDA guidance and spoken with the FDA directly, that is not the case. Fever cams are considered medical devices regardless of where they are used and when the COVID-19 crisis is over, they will likely be required to obtain 510k clearance once again. (The FDA's new policy is explicitly temporary).
As to your question on your contracts covering camera installations - we can't provide advice on this matter to your firm. Please review the new FDA guidance and feel free to contact the FDA directly, in our experience they were quite responsive.
Thanks and all the best,
Charles Rollet, reporter
IPVM
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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
ken@kirschenbaumesq.com
www.KirschenbaumEsq.com
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