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Research ArticleResearch Briefs

Clinical Interpretation of Peripheral Pulse Oximeters Labeled “Not for Medical Use”

Arlene J. Hudson, John Benjamin, Timothy Jardeleza, Curt Bergstrom, William Cronin, Mario Mendoza and Lex Schultheis
The Annals of Family Medicine November 2018, 16 (6) 552-554; DOI: https://doi.org/10.1370/afm.2317
Arlene J. Hudson
1Department of Anesthesiology, Uniformed Services University of the Health Sciences, Bethesda, Maryland
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  • For correspondence: Arlene.hudson@usuhs.edu
John Benjamin
2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland
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Timothy Jardeleza
2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland
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Curt Bergstrom
2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland
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William Cronin
2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland
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Mario Mendoza
3Center for Device Evaluation and Rehabilitation Health, Anesthesia Devices Branch, Food and Drug Administration, Silver Spring, Maryland
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Lex Schultheis
4Fischell Department of Bioengineering and Director of Regulatory Science Initiative, University of Maryland, College Park, Maryland
5FDA Center of Excellence in Regulatory Science, College Park, Maryland
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Abstract

The purpose of our study was to clarify limitations of off-label use for low cost nonmedical use (NMU) pulse oximeters by primary care providers. These devices are widely marketed over the Internet and in drugstores but are not intended for medical use or reviewed by the Food and Drug Administration (FDA). Our study compared oxygen saturation (SpO2) in patients from 1 medical use (MU) pulse oximeter to 8 NMU pulse oximeters. Measured arterial oxygenation (SaO2) was compared with SpO2 when available. In patients who were normoxic (SpO2 ≥90%), all oximeters exhibited similar readings. This finding suggests that NMU pulse oximeters may be able to rule out hypoxemia in clinical settings.

Key words
  • device
  • oximetry
  • regulation
  • safety
  • Received for publication May 21, 2018.
  • Revision received September 5, 2018.
  • Accepted for publication September 11, 2018.
  • © 2018 Annals of Family Medicine, Inc.
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The Annals of Family Medicine: 16 (6)
The Annals of Family Medicine
Vol. 16, Issue 6
November/December 2018
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Clinical Interpretation of Peripheral Pulse Oximeters Labeled “Not for Medical Use”
Arlene J. Hudson, John Benjamin, Timothy Jardeleza, Curt Bergstrom, William Cronin, Mario Mendoza, Lex Schultheis
The Annals of Family Medicine Nov 2018, 16 (6) 552-554; DOI: 10.1370/afm.2317

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Clinical Interpretation of Peripheral Pulse Oximeters Labeled “Not for Medical Use”
Arlene J. Hudson, John Benjamin, Timothy Jardeleza, Curt Bergstrom, William Cronin, Mario Mendoza, Lex Schultheis
The Annals of Family Medicine Nov 2018, 16 (6) 552-554; DOI: 10.1370/afm.2317
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