SIA Asks FDA For Crackdown on Non-Compliant Temperature Systems

IPVM worked with the Security Industry Association (SIA) on a letter sent to the FDA calling on them to take action "protecting public health and safety by enforcing the guidelines."

This 1-minute video explains the issues involved, and why a crackdown is needed:

SIA Letter Overview

The letter calls out solutions not following FDA screening guidelines, and those that sell them:

I am writing to bring attention to the issue of some companies and solutions that are not following FDA guidelines and the standards within while claiming to detect elevated human temperatures for the purpose of mitigating the spread of disease. These non-compliant systems have the potential to endanger public safety. [emphasis added].

Further stating:

Some products introduced during [the pandemic] are missing the mark when it comes to enhancing public safety. These failures come as a result of not following the guidance.

In particular, the letter identifies lacking enforcement of guidelines by the FDA as a cause:

Without enforcement of the FDA guidelines, the result has been confusion in the market which can lead to a false sense of public safety.

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It further states concern over the risk to the industry at-large:

The proliferation of solutions that cannot function as marketed also negatively affects makers, resellers and users of solutions that do follow the guidelines.

Wall Street Journal Report on SIA Letter to the FDA

On November 3, 2020, the Wall Street Journal covered SIA's letter in a piece exploring problems with the market for temperature screening, in particular, the consequences of the FDA's decision to not enforce guidelines for these medical devices during the pandemic:

The move prompted many new sellers, including many with little or no experience with medical devices. Many of these sellers rely on inexpensive imports from China that they rebrand, sometimes using misleading marketing materials to target school districts, airports, hospitals and businesses at a steep markup, longtime vendors and scientists say.

The piece also covered the $1 million purchase of Hikvision thermal cameras without blackbodies and intending to screen 30 per second, reported in an investigation by IPVM.

IPVM Research on Thermal Cameras

In the past 6 months, IPVM has tested 26 of these systems.

Guidelines for Usage: FDA Gives Guidance on 'Coronavirus' Thermal Fever Detection Systems, and World IEC Fever Screening Standards Explained.