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US Food and Drug Administration (FDA) Issued an alert For consumers, healthcare providers, and other users of thermal imaging systems that measure body temperature where improper use can produce inaccurate measurements.
The system is used to check for fever in schools, workplaces, airports, grocery stores and other public buildings and is provided as the first line of defense to safely open during a pandemic. However, a new study by surveillance research organization IPVM may miss important indicators of coronavirus infection.The study is set to be published in Journal of Biomedical Optics, according to The Washington Post.
FDA warning on Thursday night Position We shared the survey results with the agency, Include Position Report..
This system is known as a remote thermography system, infrared thermograph, thermal camera, and “fever camera”.This alert is not it According to the FDA’s press, it is associated with a portable non-contact infrared thermometer (NCIT) used for personal screening.
The FDA states that risks are likely to exist if the thermal imaging system scans multiple individuals at the same time.
The FDA also issues warnings to companies that sell unapproved, unapproved, and unauthorized thermal imaging systems. Certify Global Inc, Kogniz Inc, Opgal Optronic Industries Ltd,and Thermabis..
Researchers have found that many thermal imaging devices use software that can make people who have a fever look good.
The· Position Seven popular scanners reportedly try to “normalize” people’s temperature readings to compensate for low-cost sensor inaccuracy and unpredictable factors in actual testing. ..
“But that’compensation algorithm’ [researchers] Claim and significantly undermine the medical usefulness of the device. According to their study, enthusiasts with a core temperature of 100.4 degrees can be evaluated by test devices as having a temperature of 98 degrees, which is within a healthy range. “
Useful even when “properly used”
William Maisel, MD and MPH, Chief Medical Officer and Director of the Product Evaluation and Quality Department of the FDA’s Device and Radiation Health Center, said in an alert announcement: “Thermal images are not an effective diagnostic device for COVID-19, but they can determine if someone is hot. This can be an important risk management tool when used properly during a pandemic. However, improper use and sale of thermal imaging systems can lead to inaccurate temperature readings and pose a potential risk to public health. “
FDA offers to mitigate risk Recommendations for consumers, healthcare providers, and other users About proper and improper use of these systems.
In these recommendations, the FDA’s advice includes measuring only the temperature of one person at a time. And the temperature of the human skin gives time to adapt to changes in the environment, for example when entering a building. In addition, read the recommendations. People who are scanning the temperature should not wear hats or glasses. Hair should be pulled away from the face.
The FDA typically requires thermal scanners and other medical devices to test for safety and effectiveness under 510 (k) clearance.But in april Position “The agency said it no longer requires pre-marketing reviews or objections to unexamined devices that” did not create undue risk. ” “”
Researchers estimate that 200 companies currently manufacture or promote their devices. They say untested systems can fuel false reassurance that endangers public health.
In addition, fever is the only possible symptom of COVID-19 infection, and not all infected people become hot.
Marcia Frellick is a freelance journalist based in Chicago. She has previously contributed to the Chicago Tribune, Science News, Nurse.com and was the editor of the Chicago Sun-Times, Cincinnati Enquirer, and St. Cloud (Minnesota) Times. Follow her on Twitter. @mfrellick ..
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