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

doi:10.1370/afm.2317

Clinical Interpretation of Peripheral Pulse Oximeters Labeled "Not for Medical Use"

Ann Fam Med. 2018 Nov;16(6):552-554. doi: 10.1370/afm.2317.

Authors

Arlene J Hudson¹, John Benjamin², Timothy Jardeleza², Curt Bergstrom², William Cronin², Mario Mendoza³, Lex Schultheis^{4

5}

Affiliations

¹ Department of Anesthesiology, Uniformed Services University of the Health Sciences, Bethesda, Maryland Arlene.hudson@usuhs.edu.
² Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland.
³ Center for Device Evaluation and Rehabilitation Health, Anesthesia Devices Branch, Food and Drug Administration, Silver Spring, Maryland.
⁴ Fischell Department of Bioengineering and Director of Regulatory Science Initiative, University of Maryland, College Park, Maryland.
⁵ FDA Center of Excellence in Regulatory Science, College Park, Maryland.

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.

Keywords: device; oximetry; regulation; safety.

Publication types

Observational Study

MeSH terms

Adolescent
Adult
Aged
Aged, 80 and over
Blood Gas Analysis / methods*
Clinical Competence
Clinical Decision-Making / methods
Cross-Sectional Studies
Decision Support Systems, Clinical
Female
Humans
Hypoxia / diagnosis*
Male
Middle Aged
Off-Label Use*
Oximetry / methods*
Primary Health Care / methods*
Young Adult