KEN KIRSCHENBAUM, ESQ
ALARM - SECURITY INDUSTRY LEGAL EMAIL NEWSLETTER / THE ALARM EXCHANGE
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More on Thermal Imaging cameras and if you can sell them
Hello Mr. Kirschenbaum,
Thanks for your replies and for updating your legal analysis on fever cameras following our requests. However, there is one important part of your post which requires correcting:
“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.”
As shown by our article, which is based on information given to us directly by the FDA itself, all fever detection cameras are medical devices. It is incorrect to suggest that some fever cams are medical devices, and some are not. the FDA states quite clearly that thermal cams are medical when they're being used to measure elevated skin temperature:
“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.”
Thanks very much,
I don’t believe my conclusion requires correction. The alarm industry can install the thermal cameras as long as they are marketed and labeled correctly. The thermal imaging cameras should be used for “initial body temperature measurement for triage use.” The FDA guideline is unclear because it defines medical use when the device is intended for “diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease”. FDA considers the thermal imaging cameras medical devices requiring FDA approval unless used for purposes other than detecting elevated skin temperature, which is how the alarm industry intends to use the devices during this pandemic. FDA will not object to selling and installing these devices during the pandemic [which is the only time customers have expressed an interest in the devices], so I am not sure what all the fuss is about. Alarm dealers can sell and install the devices presently. When the pandemic is over, presumably along with the demand for these products, the manufacturers can decide if they want to get FDA approval. At least during the pandemic crisis the FDA will not object to using the devices for “triage”, which has a different meaning than “diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease”, the definition of a medical device.
As used here the word “triage” can only mean “to quickly separate”. A device used for triage is not a device used for medical purposes: diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
The alarm industry is not installing thermal imaging devices for medical purposes, at least not during this pandemic. FDA guidelines do not prohibit the sale and use of these non-FDA approved cameras during the pandemic crisis. While some are interpreting the FDA position to inhibit the sale, installation and use of the thermal imaging camera, the stated goal of the FDA is to actually promote the use of the devices during the pandemic.
This is from the FDA regarding its April 2020 Guidelines:
“Docket Number: FDA-2020-D-1138 Issued by: Center for Devices and Radiological Health, Office of Product Evaluation and Quality
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide a policy to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act (42 U.S.C. 247d(a)(2)).”
Perhaps I am addressing a different issue than IPVM and others who are expressing opinions. I am not caught up with whether the device is medical or non-medical, whether it needs FDA approval or not. At least for now, alarm companies can sell and install the cameras. To those that caution that the cameras can only be installed in installed correctly, what can I say? What alarm equipment can be installed the wrong way? An alarm dealer is expected to install equipment in accordance with manufacturer guidelines and any AHJ requirements. FDA may very well be the AHJ and it has promulgated installation and use guidelines that should be consistent with manufacturer guidelines.
My analysis that the devices can be sold and installed, based on currently available information, hasn’t changed, but to clarify, alarm dealers [I am not addressing manufacturers] should be careful to describe the service and equipment properly. The Commercial All in One has been updated to include language, and protection, for these thermal imaging devices. Be sure to update your contract before selling these devices. To avoid having the thermal camera device come under possible FDA regulations for medical devices be sure not to describe the purpose or intended use as “measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body.” The description you can use is that the device is intended as an “initial body temperature measurement for triage use; that the equipment is intended to be used for adjunctive diagnostic screening only so that elevated body temperature must be confirmed with another evaluation method; and the seller and end user should agree that the equipment does not create undue risk.
If you want to see how I arrive at this conclusion, keep reading.
Charles has an article in IPVM on May 28, 2020 which states:
“The FDA referred IPVM to its official policy on this, How To Determine If Your Product Is A Medical Device, which states that a product is a medical device not based on labeling but on whether it 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 animal”
Charles then concludes that: “Clearly, the fever cameras part of the current pandemic-induced Gold Rush are intended to help "in the diagnosis of disease" (by helping find fevers) and aid in the "mitigation" and "prevention" of disease, i.e. COVID-19.”
I am not convinced that conclusion is accurate. The cameras are intended for “triage” not diagnosis of any illness. The FDA position is clear, but Charles’ conclusion is based on deeming the devices for diagnosis. Thermal Imaging cameras are medical devices when “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 animal”. This definition is indisputable. However, a thermal imaging camera installed in a non-medical facility and non-medical purposes is not intended for diagnosis. The cameras cannot identify Covid-19 or any other illness. And why does this matter? Clearly the FDA has stated that the cameras can be installed and used. ACLU is not the AHJ and its concerns for privacy and liberty are for another day.
The latest word from the FDA is its April 2020 Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff. The policy recognizes that “There is currently an outbreak of respiratory disease caused by a novel coronavirus.”
“FDA believes the policy set forth in this guidance may help address urgent public health concerns raised by shortages of temperature measurement products by helping to clarify the regulatory landscape and expand the availability of telethermographic systems used for initial body temperature measurements for triage use during this public health emergency.”
The term “triage” is not defined in the Guideline. While it may be defined and well understood by those expert in FDA terminology and papers, here it can only mean to quickly separate; those identified by the camera as having elevated skin temperature can then be evaluated with a proper medical device approved by the FDA for diagnosis purposes.
Next, let’s examine the scope of what FDA intends to govern:
“There are many products marketed in the United States as telethermographic systems that detect infrared radiation and convert such measurements into a temperature measurement.
Telethermographic systems that meet the definition of a device under section 201(h) of the FD&C Act (21 U.S.C. 321(h)) are regulated by FDA.
Generally, telethermographic systems fall within the definition of a device when they are intended for a medical purpose, including for use by health care professionals or others for body temperature assessment.8 Telethermographic systems that are not intended for a medical purpose are not medical devices as described in further detail below.
8 As used in this guidance “intended for a medical purpose” means that the device is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease and, therefore, meets the definition of “device” set forth in section 201(h) of the FD&C Act (21 U.S.C. 321(h)).
Thermographic systems may be marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, when marketed for these non-medical applications, FDA device marketing authorization is not required, and all the other medical device requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products.”
”Telethermographic systems are 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. When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether:
1) They are labeled or otherwise intended for use by a health care professional;
2) They are labeled or otherwise for use in a health care facility or environment; and
3) They are labeled for an intended use that meets the definition of a device, e.g., body temperature measurement for diagnostic purposes, including such use in non-medical environments (e.g., airports).”
The third criteria raises concern, but shouldn’t. First of all, criteria 3 is linked to criteria 2. Properly construed, the device would need to be labeled or for use in a health care facility or environment AND labeled as a device intended to body-temperature measurement for DIAGNOSTIC purposes, including such use in non-medical environments (e.g.airports).”
FDA then cautions:
“The enforcement policy outlined below is intended to apply to all telethermographic systems that are intended for medical purposes for the duration of the public health emergency related to COVID-19. As such, FDA recommends that manufacturers of telethermographic systems that were not previously intended for medical purposes, but that are now intended for medical purposes, review the enforcement policy in Section IV.C.”
Are the cameras to be used for diagnostic screening? No, they are intended for “initial body temperature measurement for triage use.”
“In general, manufacturers of telethermographic systems intended for adjunctive diagnostic screening are required to submit a premarket notification pursuant to section 510(k) of the FD&C Act (21 360(k)) and 21 CFR 807.81 to FDA and receive FDA clearance prior to marketing these devices in the United States, as well as comply with postmarketing requirements.
To help ensure the availability of products that might offer benefit to health care providers and the general public during the public health emergency, FDA does not intend to object to the distribution and use of telethermographic systems intended for initial body temperature assessment for triage use as described in the Scope (Section III) without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: submission of a premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR 807.81, Reports of Corrections and Removals requirements in 21 CFR Part 806, Registration and Listing requirements in 21 CFR Part 807, the Quality System Regulation in 21 CFR Part 820, and Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR 801.20.”
Manufacturers and alarm dealers who intend to sell and install the cameras should make sure to promote and label the product and service properly to comply with this further guideline:
An example of such a modification includes a change to the indications for use from the “measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body” to providing an “initial body temperature measurement for triage use.”
FDA believes devices included in this enforcement policy will not create such an undue risk where:
· The performance and labeling elements in Section IV.D are met, and
· An elevated body temperature measurement is confirmed in the context of use with secondary evaluation methods (e.g., non-contact infrared thermometer (NCIT) or clinical grade contact thermometer).
FDA then makes non-binding recommendations on the use of the cameras, which has nothing to do with whether you can sell or use the devices, just how to if you do use them:
“FDA recommends that the device:
1) Is tested and labeled consistent with the following standard: IEC 80601-2-59:2017: Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening; OR
2) Is tested using alternative performance specifications that provide similar results to IEC 80601-2-59:2017. This could include:
a) The laboratory temperature accuracy of a screening telethermographic system, including the measurement uncertainty, is less than or equal to ±0.5°C (±0.9°F) over the temperature range of at least 34-39°C (93.2-102.2°F);
b) The system includes an accurate blackbody temperature reference source;10
c) Both stability and drift are less than 0.2°C (0.36°F) within a timeframe specified by the manufacturer; and
d) The device risk assessment addresses all potential safety issues, including:
i) Electrical safety;
ii) Electromagnetic compatibility;
iii) Mechanical safety;
iv) Excessive temperatures and other hazards;
v) Accuracy of controls, instruments, and information display;
vi) Considerations for software associated with Programmable Electrical Medical Systems including network connections;11 and
Finally, FDA recommends certain labeling, which falls on the manufacturers, not the dealers, though dealers may want to use devices that have the following information on the device label:
“In addition, FDA recommends that the devices described above use labeling that helps users better understand the device, such as:
1) The labeling includes a prominent notice that the measurement should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease;
2) The labeling includes a clear statement that:
a) Elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer):12
12 This labeling recommendation is consistent with IEC 80601-2-59: 2017.
b) Public health officials, through their experience with the device in the particular environment of use, should determine the significance of any fever or elevated temperature based on the skin telethermographic temperature measurement;
c) The technology should be used to measure only one subject’s temperature at a time; and
d) Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement.
3) The labeling includes a clear description of:
a) Device performance specifications and the methodology and frequency of any calibration needed to maintain the labeled specifications;12
b) How to use the thermal image to make a temperature measurement to within the stated device accuracy;
c) A description and purpose of the blackbody reference source (used for thermal drift compensation) and its importance in obtaining an accurate temperature assessment;
d) The reference body site used for temperature estimation, including any calibration or correction needed to estimate the temperature at that location, and the accuracy of the measurement at the reference site (e.g., oral, tympanic membrane);
e) How different environmental and system setup factors can affect the measurement, including the body site chosen for measurement, the condition of the screening site (e.g., screening background, ambient temperature and humidity, airflow);13
f) Different factors to consider in the design of the facility protocol (e.g., installation, viewing angle, blackbody temperature reference source);14
g) The installation procedures and qualification testing that should be performed during installation or when imaging equipment is being relocated;15 and
h) The appropriate imaging distance based on the spatial resolution and performance of the camera.16
4) The labeling references and is consistent with the guidelines in ISO/TR 13154: 2017: Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph; and
5) The labeling highlights the differences in design, indications, or functions, as applicable, compared to the unmodified, FDA-cleared version of the product or includes a clear identification that the device is not FDA-cleared or approved.
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