FDA-approved remote pulse oximetry monitoring is effective in managing several health conditions. Additionally, it adds significant benefits in healthcare such as improved health outcomes and boosted patient safety. This guide addresses conditions that can be monitored with pulse oximeters, patient safety, effectiveness, and 5 benefits associated with remote pulse oximetry monitoring. 

What is Remote Pulse Oximetry Monitoring? 

Remote patient monitoring involves using FDA-approved medical devices to measure vital signs such as lung capacity and blood-oxygen levels from home. With remote patient monitoring (RPM), patients must take their measurements on a regular basis. In other words, at least 16 days a month. In brief, pulse oximetry determines how well a patient’s lungs are functioning by using a light that measures oxygen levels in red blood cells. 

Blood-oxygen levels are typically tested at the fingertips with a pulse oximeter to measure how well oxygen is being distributed to areas furthest from the heart. FDA-approved pulse oximeters give clinicians accurate measures of blood oxygen level, pulse rate, and perfusion index to help in developing patient treatment plans. 

Pulse Oximetry RPM: Which Conditions Can be Monitored? 

As according to many medical conditions, monitoring blood oxygen levels for pulmonary conditions is important to effectively treating patients. Because respiratory symptoms of COPD are not always noticeable, frequent monitoring of lung capacity or blood oxygen levels promotes early detection and timely treatment. For instance, patients with symptoms of mild chronic obstructive pulmonary disease (COPD) can experience critical drops in blood-oxygen levels and not even know it. 

In general, a good saturation number (SpO2) is above 90-92%. A good pO2 is over 60-65. If a patient’s blood oxygen saturation level (SpO2) is under 90%, the remote patient monitoring platform automatically alerts the clinician for quick intervention. To enumerate, the clinician and patient can access the readings whenever they want.

Pulse oximetry may be used for many clinical conditions. Some use cases include:

• COPD: Monitoring leads to early identification and prompt treatment, preventing symptoms from worsening.
• Congestive Heart Failure: Keeps check on low oxygen saturation, which is a common symptom. 
• Asthma: When an asthmatic’s oxygen levels trend downward, it can be a sign of impending respiratory failure. 
• Lung cancer: Used to predict cardiopulmonary morbidity after lung resection in cancer patients.
• COVID-19: Shows effectiveness and safety for monitoring lung deterioration at-home. 

Pulse Oximetry Devices: What’s Safe? 

According to the FDA, two categories exist for pulse oximeters: prescription use and over-the-counter (OTC). COVID-19 caused a surge in pulse oximeters usage. Meanwhile, one study found that over-the-counter pulse oximeters can be flawed. For one thing, the risk of inaccuracy under certain circumstances can be dangerous. This caused the FDA to issue urgent alerts warning patients and health care providers that OTC pulse oximeters have limitations.  

Below is a list of details of prescription vs. OTC pulse oximeters: 

Prescription Pulse Oximeters

The FDA requires that these pulse oximeters undergo clinical testing to confirm their accuracy.

• Fully reviewed by the FDA
• Receive 510(k) clearance
• For use in hospitals, physician offices, and health clinics 
• Available only with a prescription when prescribed for home use

Over-the-counter (OTC) Pulse Oximeters

 It is important to note: these OTC oximeters are not cleared by the FDA and should not be used for medical purposes. 

• Sold directly to consumers in stores or online
• This may include smartphone apps developed for estimating oxygen saturation
• Sold as general wellness products; not intended for medical purposes
• Do not undergo FDA review

Effectiveness & Benefits of Remote Pulse Oximetry Monitoring

In particular, the key to effective management of chronic conditions is focusing on proactive care. Overall benefits of remote patient monitoring include making quality healthcare more accessible and convenient. In addition, RPM reduces the risk of hospitalization by focusing on preventive care. With RPM patients are encouraged to engage in healthier choices because the results of their lifestyle choices can be evidenced in their regular biometric readings.  

1) RPM & Pulse Oximetry Means Accurate & Reliable Data 

Before remote pulse oximetry monitoring patients had to log vital sign measurements and present them to their physician during an office visit. The data provided to a physician or other qualified healthcare professionals could be invalid and  unreliable for several reasons, such as human error, missed medication, and so on. 

Accurate data is key to reducing the risk of hospitalization by focusing on prevention over treatment. One study assessed the reliability of a remote patient monitoring system. The researchers reported that the device was ‘quite’ effective in providing accurate remote health data. In fact, they noted that the device functioned remarkably well among the geriatric population. In addition, it was noted that well-designed systems have the potential to provide significant at-home support for seniors and chronic care patients.

Another benefit of remote monitoring is that remote patient monitoring services companies provide devices as well as qualified clinical staff that can perform RPM services to assist with managing patient data. The exact capabilities of even FDA-approved remote monitoring devices and HIPAA compliant software platforms vary considerably. Therefore, devices and software quality should be researched prior to choosing a RPM service company. Quality and reputation are essential in providing real-time monitoring, data accuracy and analysis.

2) Improving COVID-19 & Chronic Condition health outcomes.

Ultimately, remote patient monitoring allows clinicians to keep tabs on their at-risk patients between visits for optimal care. Regular monitoring also puts patients in better control over their health. Because respiratory symptoms aren’t always noticeable, frequent monitoring of lung capacity or blood oxygen levels can promote early detection and timely treatment.

UC Davis Medical center introduced remote patient monitoring for high-risk patients with Chronic Obstructive Pulmonary Disease (COPD). The motivation to build out this program came from research showing that among Medicare beneficiaries admitted to the hospital for COPD, 19.6% were readmitted within 30 days. Likewise, a 2022 systematic review published in the Lancet reported that monitoring COVID-19 patient’s pulse oximetry level at-home was deemed safe and could help pinpoint signs of condition deterioration. 

3) Reducing Costs with Remote Pulse Oximetry

Chronic diseases are the leading causes of illness, disability, and death in the United States. By utilizing remote physiological monitoring, chronic disease patients are much less likely to require emergency care or be admitted to the hospital. This significantly reduces healthcare costs. 

The cost-effectiveness of RPM can be worthwhile in terms of a better quality of life. Healthcare IT News estimated that for every 500 high-risk Medicare patients with multiple chronic conditions, health systems can realize $5.2 million in annual cost savings. In addition, remote patient monitoring allows clinicians to manage more patients, making efficient use of their time and resources while increasing revenue.

4) Remote Monitoring Shows Improved Patient Adherence 

With traditional at-home vital signs monitoring, patients are not reminded to take regular readings. As a result, providers do not know if patients are compliant with taking measurements. Moreover, the time between taking the reading and a face-to-face visit with a provider is quite long and their health might deteriorate during that period.

Remote patient monitoring improves patient treatment and medication adherence. A 2019 study found that chronic disease patients who utilized RPM devices had increased knowledge of their conditions and improved ability to manage their health and make care decisions.

5) RPM Pulse Oximeters: No Real Risks Involved

The final benefit is best said by the American Lung Association: there are no known risks or dangers of using an FDA-approved pulse oximeter when the values are reviewed and monitored by a qualified healthcare professional. As mentioned previously there can be risks associated with OTC pulse oximeters.

If you have a problem with a pulse oximeter, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

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