FDA: Policy Allows for Expanded Use of Certain Remote Patient Monitoring Devices

The Food and Drug Administration is allowing expanded use of certain noninvasive, vital sign measuring devices to help monitor patients remotely during the coronavirus disease 2019 (COVID-19) public health emergency. 

Expanding the use of remote patient monitoring capabilities allows for increased access to patient physiological data and facilitates patient management while reducing the need for in-office or in-hospital services during the COVID-19 pandemic. The Agency believes the policy may ease the burden on hospitals, healthcare facilities, and healthcare professionals while reducing the potential risk of exposure. 

The Agency stated that it does not “intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.” The policy includes the following noninvasive remote monitoring device types: 

• Clinical electronic thermometer
• Electrocardiograph (ECG) 
• Cardiac monitor 
• Electrocardiograph software for over-the-counter use
• Pulse Oximetry
• Noninvasive Blood Pressure 
• Respiratory Rate/Breathing Frequency 
• Electronic Stethoscope 

“Allowing these devices to be used remotely can help healthcare providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “This policy reflects the FDA’s commitment to ease burdens on healthcare providers and facilities as they face this public health emergency.” 

The policy is intended to remain in effect only for the duration of the COVID-19 public health emergency declared by the Department of Health and Human Services (HHS).

On the heels of the FDA’s announcement, AliveCor announced that it’s 6-lead personal ECG device, KardiaMobile 6L, can now be used to measure a patient’s QTc to detect potential QT prolongation. In a press release, the Company noted that this expanded use may be important for COVID-19 patients being treated with off-label hydroxychloroquine and azithromycin as both drugs have the potential to prolong the QT interval.  

For more information visit fda.gov.