Telethermography Devices: Current FDA Considerations
Adapting thermography machines to address COVID-19 issues qualifies them as medical devices, which can pose unique challenges for businesses that are unfamiliar with the FDA.
- By Susan Kohn Ross
- May 19, 2020
In the current return to work environment, there is a significant focus among building operators, employers and just about everyone else on temperature taking as the singular criteria by which to determine who may return to work, enter a building and otherwise return to some semblance of the new normal. Those who sell and operate telethermographic equipment are looking at how their devices can be adapted to take advantage of this unexpected business opportunity. To that end, these units are being repositioned for a different market, and any time one enters a new market, there are challenges to keep in mind which, if not properly factored into the operation from the outset, can become significant hurdles later in time. Adapting thermography machines for this new use qualifies them as medical devices, which is certainly a situation that can become quite challenging and, if not done right, quite costly in terms of the downside consequences.
To start, because a thermography device will now be reporting an individual’s temperature and the degree of the temperature reported will be used to determine whether that person is well enough, thermography units are now considered medical devices. As such, they are subject to the laws, regulations and guidance administered by the Food and Drug Administration (FDA), and those rules are quite complex and can easily entrap the inexperienced. By way of an example, the typical seller and buyer consider labeling to consist of what is on the product, any written materials which accompany the product and its inner and outer packaging. While those are certainly accurate examples, the FDA includes in its definition of labeling what you put on your website and in your advertising and even goes so far as to consider what your customers say in their marketing materials as well.
Many who import products are familiar with the jurisdiction of Customs and Border Protection at the borders. FDA certainly has similar jurisdiction, but it also has domestic jurisdiction and has been using it liberally over the years, only more so during the COVID-19 pandemic. On May 7, 2020, the FDA distributed a press release advising it has issued 42 warning letters focused on companies it deemed to be conducting scams by way of making bogus claims. FDA also trumpeted the efforts of Operation Quack Hack, in which “hundreds” of “fraudulent” products have been intercepted, including drugs, testing kits and personal protection equipment (PPE), due to their false claims. To be clear, when FDA uses the phrase “false claims,” it means there are statements being made on or about the product which cannot legally be made because the product cannot do what is claimed, but also because the product does not qualify to make those claims due to how it is regulated. The simplest example relates to the sale of a soda can – you cannot legally say, “Drink this liquid, and it cures cancer”!
Seeking to facilitate the importation of PPE and other products in order to deal with the pandemic, the FDA enacted certain emergency use authorizations (EUAs). This is the FDA’s way of loosening the restrictions to allow the badly needed equipment to become more widely available as quickly as possible. You can find the most up-to-date information on this topic here. The guidance regarding telethermographic devices can be found here. It is important to understand from the outset that a guidance document is not the same as a law or regulation, although the FDA interprets its guidance documents as equivalent to both. Certainly, when it comes to the pandemic, other agencies will treat the guidance similarly.
FDA Label Requirements
If the thermographic equipment is being used, for example, at an airport to detect items which are not permitted aboard a plane, nothing has changed, but when used for the measurement of self-emanating infrared radiation that reveals temperature variations on the surface of the human body, these thermographic units are considered medical devices. As noted, there are limits to the claims that can be made about them, but the FDA also demands to know:
- Whether the devices are labeled or otherwise intended for use by health care professionals
- Whether they are labeled or otherwise for use in a health care facility or environment
- Whether they are labeled for an intended use that meets the definition of a device (e.g., body temperature measurement for diagnostic purposes).
Do your products comply? Are the labels provided to users clear? Are the directions user-friendly? Do your labels comply with the current version of the FDA Recognized Consensus Standards Database?
Is the variance of the temperatures registered within tolerance? Is the blackbody emissivity properly compensating for thermal drift? Are the relevant safety issues adequately addressed? Are all the other criteria met correctly? Typically, all of this would be addressed in advance by the filing of a pre-marking or 510(k) notification; however, that is suspended for now, which means the FDA is not going through the same vetting as it would under normal circumstances.
Because the need for the pandemic-related equipment is so strong, one of the key headaches will be identifying and vetting suppliers. In some cases, new suppliers will present themselves. All suppliers need to be checked, as everyone is in newly chartered waters, and not just for the quality and capability of their equipment, but also their backgrounds, their financial stability and their ability to perform. Put the other way, you need to figure out if you are being presented with a scam.
One of the more significant challenges is payment for the equipment. Often, letters of credit and similar payment methods are employed. The new norm is for funds to be put in escrow which are released when certain conditions are met. Who will be the escrow holder? What are those conditions? What is the relevant timing? Don’t make the rookie mistake of thinking just because the air waybill or bill of lading was issued that the goods are on board the transporting carrier.
Also, be sure to clarify what trademarks and copyrights appear on the product and its packaging. Is any of the technology subject to a patent? Getting the intellectual property analysis right is a significant challenge at the best of times, magnified now by the speed which currently applies. It is a real nightmare now, as all too often the goods are not seen before they are shipped. Given the circumstances, consider using an inspection service. If you get this topic wrong, CBP has the ability to seize the equipment at the border, if any unauthorized or counterfeit trademarks or copyrights appear. To make matters worse, not only could you have the goods seized with no ability to get them back due to the trademark or copyright infringement, but the law also permits the imposition of a civil fine for trading in counterfeit goods! Patents are enforced differently at the border, but not getting the intellectual property issue right can at the very least result in a domestic lawsuit for infringement and significant damages, so this is not a topic to gloss over.
You also want to make sure you are using up-to-date terms and conditions in your contracts, including an updated force majeure clause. Existing contracts often have a very general force majeure clause which does not specifically mention pandemics, widespread public health crises and similar conditions. If you cannot get your goods because the area around where they will be shipped is quarantined, you want to be able to get out of your contract. Are you sure you can with your current force majeure clause?
Given the experienced nature of most telethermographic equipment traders, only for the sake of completeness do we mention the need to be clear about the details of the commercial deal, including timing, but also obviously the quality of the product and how it is labeled. The key in the current context is to be certain the stated intended use and how the product is actually labeled (use the FDA’s broad definition) are in sync. Make sure that expected delivery terms and timing clearly. Also make sure to include any agreed services, such as warrantees, technical support, training, service and responsibility for and calibration of the equipment.
Insurance. Another key point is to check your insurance coverage. What does it include and exclude? If you sell equipment for uses or that make claims about which your insurance carrier has not been advised, will your existing coverage still apply? Remember that as a general rule, everyone in the chain of distribution could be liable for any products liability (and other injury) claims made.
Customer service. In addition to making sure the equipment is well suited for its intended use, is delivered on time and does as promised, you may also want to have a conversation with your customers about their developing a written policy and procedure for the use of your equipment. You might want to recommend it include such topics as:
- The temperature reading that will cause someone to be denied access.
- In the case of an employee who is not permitted access, who in the company will be notified
- How to handle a troublesome party.
- What records will be maintained about the scans performed and the access denied.
- Who receives those records.
- If the facility is an employer, decide whether visitors should be given a privacy notice.
- If the site where the equipment will be used is in California, has the employer determined whether or not the temperature taking process is subject to disclosure under the California Consumer Privacy Act.
- Have you implemented such a policy?
A best practice is to provide signage indicating that the temperature of every individual will be taken and anyone who objects should not enter. This is, of course, in addition to the Centers for Disease Control and Prevention-recommended signage cautioning that anyone who is sick is asked not to enter the building, and so on.
Some additional points the signage might include are:
- The screening is not a diagnostic test and only measures fever. There are many causes of fever and someone might be ill and not have a fever. If you are unwell, call your doctor.
- An employee who is denied access due to their fever reading must report their absence to their employer following regular procedure.
Finally, as noted above, there are significant privacy issues the temperature-taking and reporting process involves. Is the equipment recording the temperature readings? If so, what is done with that data? Will names be taken and temperatures recorded against those names?
What data can your equipment record? How long can it retain that data? Is the data reported to a central server? What is being done to maintain confidentiality over the data? Who is responsible to maintain that confidentiality?
Are these points made clear in the contract you have with the buyer of your equipment? Does your contact include appropriate representations and warranties? Is there adequate limitation of liability language in that contract?
Potential consequences. When dealing with the sale of equipment of any sort, there are generally standard clauses which companies employ that cover the topics mentioned just above, but they cannot insulate you from action by the FDA, so along with making sure the commercial deal to acquire and sell/install the equipment is clear, you also want to make sure your record keeping is proper. If you ordered goods that are nonconforming and because of their nonconformity, law enforcement comes knocking at your door, can you produce documents that clearly show the nonconformity in question? How good is your record-keeping system right now? Do you have your advisory team well established, whether that is your banker, lawyer, insurance agent/broker and/or accountant.
The expectation is that once the pandemic subsides and the urgency of the circumstances is relieved, a lot of fraud (intentional and unintentional), or at least serious irregularities, will be discovered. Can you defend yourself if that happens? It’s not enough to make the deal if it costs you the company later. Are you ready?