Remote Operation of Medical Devices Designed for Bedside Use Introduces Insidious Risks
January 28, 2021 | Evaluations & Guidance
During surge periods of the COVID-19 pandemic, remotely operated therapy and monitoring solutions have been devised and deployed in some healthcare facilities. This has been done as a way to conserve personal protective equipment (PPE), minimize healthcare worker exposure to infected patients, and allow more rapid response to clinical conditions that require an adjustment to device settings by avoiding delays associated with donning PPE in order to enter the patient room.
The use of such solutions was fueled by FDA Emergency Use Authorizations (EUAs) that permitted the new or expanded use of some remote control features. Reported use cases include,...