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Fingertip Pulse Oximeter Performance in Dyspnea and Low Perfusion During Hypoxic Events

In the last few years fingertip pulse oximeters have been available in the U.S. as “health and wellness” devices without FDA clearance or need for a prescription. In this study, it’s revealed fingertip pulse oximeter with & without FDA clearance comparison among three manufacturers.
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24 November 2016
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In the last few years fingertip pulse oximeters have been available in the U.S. as “health and wellness” devices without FDA clearance or need for a prescription. Patients have begun to purchase and use these devices to guide selfcare. And to a lesser degree, some clinicians are using these uncleared devices as well as similar inexpensive FDA cleared devices in their practice.

The first fingertip pulse oximeter was introduced in 1995 by Nonin Medical. For approximately 13 years, it was the sole device in this form factor in which the entire pulse oximeter was housed in the finger sensor (display, engine, power supply and sensor). Due to convenience of size and, apparently few reported performance issues, it saw rapid adoption in the clinical environment. In the last eight years several new portable fingertip pulse oximeters have been introduced. Many of these devices are low cost and available over the counter. Anecdotal information gathered from clinicians indicate that some devices have poor performance which might be due to a combination of poor signal strength (lower perfusion) and labored breathing (dyspnea) resulting in inaccurate SpO2 and/or pulse rate.

 

Which oximeters are accurate in tracking desaturations?

Many of the new oximeters are made by two manufacturers:
• Beijing Choice Electronic Technology Co Ltd. (Beijing, China)
• Contec Medical Systems Co Ltd. (Qinhuangdao, China)

These two companies make over 30 different oximeter brands and models – major retailer brands, distributor brands, and internet brands. Some are FDA-cleared while some are “health and wellness” devices

In this study the Beijing Choice and Contec Medical fingertip pulse oximeters performed significantly worse than the Nonin Medical fingertip pulse oximeter in dyspneic, low perfusion conditions.

 

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