FDA allows expanded use of remote health monitoring devices, to limit in-person patient—provider contact during the COVID-19 outbreak
The US FDA has issued guidance concerning the expanded use of certain remote, non-invasive health monitoring devices – such as ECG monitors – to facilitate patient monitoring while reducing patient—provider contact and exposure to the novel coronavirus, COVID-19.
The outbreak of the novel coronavirus – COVID-19 – is a rapidly progressing public health emergency. In a bid to simultaneously enhance remote patient monitoring and limit face-to-face interactions between patients and healthcare providers, the US FDA has published guidance concerning the expanded use of certain non-invasive, remote health monitoring devices – such as ECG monitors. The guidance has been issued with immediate effect, without prior public comment, and is to remain in place only as long as the outbreak remains a declared public health emergency.
In the guidance, the FDA explains: “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. 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.”
The guidance highlights various non-invasive health monitoring devices that can connect to wireless networks and transmit patients’ physiological health data directly to healthcare professionals – some devices can even apply algorithms to the data, which may help healthcare providers diagnose a condition and/or its severity. The list of devices the guidance is applicable to includes ECG monitors, electronic stethoscopes and pulse oximetry devices.
Under the guidance, the FDA may allow for modifications to the hardware of the specified devices, which will enhance their remote usability. Further, so long as they do not lead to unduly elevated risks, the FDA may allow amendments to approved indications, claims or functionalities of the devices without prior submission of a premarket notification. However, such modifications would be objected if, for example, the device is intended to determine when patients need immediate clinical intervention or is to be primarily relied upon for making clinical diagnoses or treatment decisions concerning COVID-19 or coexisting conditions, as such alterations would create undue risk.
“Increased utilization of non-invasive remote patient monitoring devices may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure for patients and health care providers to SARS-CoV-2,” commented the FDA in the issued guidance.
US FDA. Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency.