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research-article

Determining critical design parameters for improved body temperature measurements: a new method and clinical study.

[+] Author and Article Information
Oleg Vesnovsky

FDA Center for Devices & Radiological Health, Silver Spring, MD 20993
oleg.vesnovsky@fda.hhs.gov

Liang Zhu

Department of Mechanical Engineering, University of Maryland, Baltimore County, Baltimore, MD 21250
zliang@umbc.edu

Laurence W Grossman

FDA Center for Devices & Radiological Health, Silver Spring, MD 20993
lwgrossman@icloud.com

Jon P. Casamento

FDA Center for Devices & Radiological Health, Silver Spring, MD 20993
jon.casamento@fda.hhs.gov

Alireza Chamani

Department of Mechanical Engineering, University of Maryland, Baltimore County, Baltimore, MD 21250
chamani1@umbc.edu

Nadeesri Wijekoon

Department of Mathematics and Statistics, University of Maryland, Baltimore County, Baltimore, MD 21250
av02016@umbc.edu

L D Timmie Topoleski

FDA Center for Devices & Radiological Health, Silver Spring, MD 20993; Department of Mechanical Engineering, University of Maryland, Baltimore County, Baltimore, MD 21250
topoleski@umbc.edu

1Corresponding author.

ASME doi:10.1115/1.4041589 History: Received May 16, 2017; Revised September 24, 2018

Abstract

The objective of this study was to determine real-world, clinical design parameters to create next generation, accurate, digital thermometers. The accuracies of three currently available store brand thermometers were compared to those measured by a calibrated reference thermometer. More than 300 healthy or sick pediatric subjects were enrolled in this study. The reference thermometer was placed at the measurement site simultaneously with the store brand thermometer and recorded the temperature continuously. Temperatures were measured both in the mouth and under the arm. The store brand thermometer measurements characteristically deviated from the reference thermometer temperature after 120 seconds, up to 3.7F, and the deviations were not consistent. The store brand thermometers had lower accuracy than the ±0.2F indicated in their Instructions for Use. The data indicated that the transient temperature profiles may not be represented by an exponential function with a single time constant. The store brand thermometers stated in their documentation that they are able to predict a body temperature based on the first 5 to 10 seconds of transient measurements, implying that they use an embedded algorithm to extrapolate to the steady-state temperature. The accuracy of those embedded algorithms was not verified by our study. A thermometer with an error of several degrees Fahrenheit may result in a false positive or negative diagnosis of fever in children. The transient temperature measurements from our clinical study represent unique and critical data for designing the next generation of readily available, highly accurate, home thermometers.

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