“NCITs may be used to reduce cross-contamination risk and minimize the risk of spreading disease. While typically 98.6°F (37.0°C) is considered a “normal” temperature, some studies have shown that “normal” body temperature can be within a wide range, from 97°F (36.1°C) to 99°F (37.2°C). Before NCITs are used, it is important to understand the benefits, limitations, and proper use of these thermometers. Improper use of NCITs may lead to inaccurate measurements of temperature.”
Visit fda.gov for more information on non-contact infrared thermometers
Figure 1: Correct Use – Forehead unobstructed, and NCIT perpendicular to forehead and used at distance identified in manufacturer’s instructions.
Figure 2: Incorrect Use – Not perpendicular to forehead
Figure 3: Incorrect Use – Forehead exposed to direct sunlight outdoors
References
Note, this information is applicable to NCITs which are intended for a medical purpose which means that the NCIT 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 Federal Food, Drug and Cosmetic Act.
- Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers
- U.S. National Library of Medicine: MedlinePlus. (2019 February). Body Temperature Norms. https://medlineplus.gov/ency/article/001982.htm
- ASTM E1965-98(2016),Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature ASTM International, West Conshohocken, PA, 2016, www.astm.org DOI: 10.1520/E1965-98R16
- ISO 80601-2-56:2017(E) Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
2017, International Organization for Standardization