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

Hudson, Arlene J.; Benjamin, John; Jardeleza, Timothy; Bergstrom, Curt; Cronin, William A.; Mendoza, Mario; Schultheis, Lex

doi:10.1370/afm.2317

Cited by 12 publications

(11 citation statements)

References 6 publications

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“…In one of the only studies to specifically examine NMU oximeters, Hudson and colleagues ( 12 ) compared oxygen saturation measurements from eight NMU devices with those from a single medical use oximeter or cooximetry and found that NMU devices had a positive predictive value of only 33% and a negative predictive value of 99% for identifying patients with hypoxemia (defined as an oxygen saturation <90% on the medical use device or cooximetry). The authors claim that there were no clinically significant differences in measured values between the NMU devices and the medical use oximeter, but a review of their modified Bland-Altman analysis indicates that there were not an insignificant number of cases in which the NMU device yielded saturation values more than 5% below the medical device, even when the true saturation was >95%.…”

Section: Available Data On Pulse Oximeter Accuracymentioning

confidence: 99%

Pulse Oximetry for Monitoring Patients with COVID-19 at Home. Potential Pitfalls and Practical Guidance

2020

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During the ongoing coronavirus disease (COVID-19) pandemic, reports in social media and the lay press indicate that a subset of patients are presenting with severe hypoxemia in the absence of dyspnea, a problem unofficially referred to as “silent hypoxemia.” To decrease the risk of complications in such patients, one proposed solution has been to have those diagnosed with COVID-19 but not sick enough to warrant admission monitor their arterial oxygenation by pulse oximetry at home and present for care when they show evidence of hypoxemia. Though the ease of use and low cost of pulse oximetry makes this an attractive option for identifying problems at an early stage, there are important considerations with pulse oximetry about which patients and providers may not be aware that can interfere with successful implementation of such monitoring programs. Only a few independent studies have examined the performance of pocket oximeters and smart phone–based systems, but the limited available data raise questions about their accuracy, particularly as saturation falls below 90%. There are also multiple sources of error in pulse oximetry that must be accounted for, including rapid fluctuations in measurements when the arterial oxygen pressure/tension falls on the steep portion of the dissociation curve, data acquisition problems when pulsatile blood flow is diminished, accuracy in the setting of severe hypoxemia, dyshemoglobinemias, and other problems. Recognition of these issues and careful counseling of patients about the proper means for measuring their oxygen saturation and when to seek assistance can help ensure successful implementation of needed monitoring programs.

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Section: Available Data On Pulse Oximeter Accuracymentioning

confidence: 99%

Pulse Oximetry for Monitoring Patients with COVID-19 at Home. Potential Pitfalls and Practical Guidance

2020

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“…There exist a limited number of studies comparing reasonably priced commercially available handheld devices to medical-standard-devices. These studies indicate that “low-cost” handheld devices provide sufficiently accurate SpO 2 values in the range of about 90–100% compared to medical devices, however, below 90%, non-medical devices decrease in accuracy [ 16 , 24 , 25 , 26 ]. This property might be a drawback for measurements at high altitudes.…”

Section: Part 1: Basic Principles Of Functioning Most Relevant Pimentioning

confidence: 99%

The Use of Pulse Oximetry in the Assessment of Acclimatization to High Altitude

Dünnwald

Kienast²,

Niederseer

et al. 2021

Sensors

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Background: Finger pulse oximeters are widely used to monitor physiological responses to high-altitude exposure, the progress of acclimatization, and/or the potential development of high-altitude related diseases. Although there is increasing evidence for its invaluable support at high altitude, some controversy remains, largely due to differences in individual preconditions, evaluation purposes, measurement methods, the use of different devices, and the lacking ability to interpret data correctly. Therefore, this review is aimed at providing information on the functioning of pulse oximeters, appropriate measurement methods and published time courses of pulse oximetry data (peripheral oxygen saturation, (SpO2) and heart rate (HR), recorded at rest and submaximal exercise during exposure to various altitudes. Results: The presented findings from the literature review confirm rather large variations of pulse oximetry measures (SpO2 and HR) during acute exposure and acclimatization to high altitude, related to the varying conditions between studies mentioned above. It turned out that particularly SpO2 levels decrease with acute altitude/hypoxia exposure and partly recover during acclimatization, with an opposite trend of HR. Moreover, the development of acute mountain sickness (AMS) was consistently associated with lower SpO2 values compared to individuals free from AMS. Conclusions: The use of finger pulse oximetry at high altitude is considered as a valuable tool in the evaluation of individual acclimatization to high altitude but also to monitor AMS progression and treatment efficacy.

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“…Some key considerations are as follows: Form factor options include clip and strap/band. Both medical use and nonmedical use pulse oximeters can be accurate under normal conditions. The main gap is accuracy under hypoxic conditions 94105 Devices receiving 510(k) clearance are a better choice because of the requirement to establish accuracy under hypoxic conditions. Results from independent validation studies 105,106 can be a reliable source for information on product accuracy. …”

Section: Vital Signs ‐ Respiratorymentioning

confidence: 99%

“…The main gap is accuracy under hypoxic conditions 94105 Devices receiving 510(k) clearance are a better choice because of the requirement to establish accuracy under hypoxic conditions. Results from independent validation studies 105,106 can be a reliable source for information on product accuracy. …”

Section: Vital Signs ‐ Respiratorymentioning

confidence: 99%

An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID‐19

Manta

Jain

Coravos

et al. 2020

Clinical Translational Sci

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The novel coronavirus disease 2019 (COVID‐19) global pandemic has shifted how many patients receive outpatient care. Telehealth and remote monitoring have become more prevalent, and measurements taken in a patient’s home using biometric monitoring technologies (BioMeTs) offer convenient opportunities to collect vital sign data. Healthcare providers may lack prior experience using BioMeTs in remote patient care, and, therefore, may be unfamiliar with the many versions of BioMeTs, novel data collection protocols, and context of the values collected. To make informed patient care decisions based on the biometric data collected remotely, it is important to understand the engineering solutions embedded in the products, data collection protocols, form factors (physical size and shape), data quality considerations, and availability of validation information. This article provides an overview of BioMeTs available for collecting vital signs (temperature, heart rate, blood pressure, oxygen saturation, and respiratory rate) and discusses the strengths and limitations of continuous monitoring. We provide considerations for remote data collection and sources of validation information to guide BioMeT use in the era of COVID‐19 and beyond.

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

Cited by 12 publications

References 6 publications

Pulse Oximetry for Monitoring Patients with COVID-19 at Home. Potential Pitfalls and Practical Guidance

Pulse Oximetry for Monitoring Patients with COVID-19 at Home. Potential Pitfalls and Practical Guidance

The Use of Pulse Oximetry in the Assessment of Acclimatization to High Altitude

An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID‐19

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