Clinical Interpretation of Peripheral Pulse Oximeters Labeled "Not for Medical Use".
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 30420372.
- Also identified by DOI 10.1370/afm.2317 and PMC identifier 6231944.
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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 (SpO<sub>2</sub>) in patients from 1 medical use (MU) pulse oximeter to 8 NMU pulse oximeters. Measured arterial oxygenation (SaO<sub>2</sub>) was compared with SpO<sub>2</sub> when available. In patients who were normoxic (SpO<sub>2</sub> ≥90%), all oximeters exhibited similar readings. This finding suggests that NMU pulse oximeters may be able to rule out hypoxemia in clinical settings.
Medical subject headings
- Blood Gas Analysis
- Hypoxia
- Off-Label Use
- Oximetry
- Primary Health Care