Clinical Interpretation of Peripheral Pulse Oximeters Labeled “Not for Medical Use”
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 Admin...
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Veröffentlicht in: | Annals of family medicine 2018-11, Vol.16 (6), p.552-554 |
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creator | Hudson, Arlene J., MD, MA Benjamin, John, MD Jardeleza, Timothy, MD Bergstrom, Curt, MD Cronin, William, MD Mendoza, Mario, MD, MS Schultheis, Lex, MD, PhD |
description | 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. |
doi_str_mv | 10.1370/afm.2317 |
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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. 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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. 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subjects | Comparative analysis Family Medicine/General Medicine Internal Medicine Licensing, certification and accreditation Pulse oximeters Research Briefs |
title | Clinical Interpretation of Peripheral Pulse Oximeters Labeled “Not for Medical Use” |
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