The FDA issued guidance for expanded use of certain remote monitoring devices to facilitate patient management while limiting physician-patient contact during the COVID-19 pandemic.
The guidance, issued March 20, is in effect only during the national COVID-19 public health emergency declared by HHS, the FDA stated in an enforcement policy notice.
The remote patient monitoring devices affected include those used to monitor BP, heart rate, respiratory rate and body temperature.
“FDA believes the policy set forth in this guidance will help address these urgent public health concerns by helping to expand the availability and capability of remote patient monitoring devices,” the agency wrote in the guidance. “Modified use of these devices may increase access to important patient physiological data without the need for in-clinic visits and facilitate patient management by health care providers while reducing the need for in-office or in-hospital services during the COVID-19 public health emergency. Increased utilization of noninvasive remote patient monitoring devices may ease burdens on hospitals and other health care facilities and reduce the risk of exposure for patients and health care providers to SARS-CoV-2.”
The specific devices mentioned in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, electrocardiograph software for over-the-counter use, pulse oximeters, devices to measure respiratory rate and breathing frequency, and electronic stethoscopes.
“These noninvasive monitoring devices have the potential to be connected to a wireless network through Bluetooth, Wi-Fi or cellular connection to transmit a patient’s measurements directly to their health care provider or other monitoring entity,” the agency wrote in the guidance. “Some of these devices also have the potential to apply algorithms to transform a patient’s physiological parameters into a novel index or alarm that may aid a health care professional in the diagnosis of a particular condition or disease state/severity.”
During the period the guideline is effective, the FDA will not 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 during the declared public health emergency without prior submission of a premarket notification.”
These changes include addition of monitoring statements related to patients with COVID-19 or coexisting conditions such as hypertension and HF, changes in indications or claims regarding use in the home care setting and changes to hardware or software to increase remote monitoring capability. – by Erik Swain
FDA. Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. Accessed March 23, 2020.