Source : Medtech Insight
The Association for the Advancement of Medical Instrumentation (AAMI) has released an emergency-use guidance that targets medical devices that can be used remotely during the coronavirus pandemic.
The consensus report – CR511, “Emergency Use Guidance For Remote Control of Medical Devices” – is an output of the AAMI’s COVID-19 Response Team; it highlights common system elements for engineers, and outlines safety and risk-control measures that manufacturers and caregivers should consider.
The CR “provides targeted design guidance to enable rapid development of remote-control capabilities using an auxiliary HMI [Human Machine Interface] with a medical device to treat patients with COVID-19,” the document says. Such devices include medical ventilators, infusion pumps and vital signs monitors, just to name a few.
The US Food and Drug Administration published in March – and later updated in October – an emergency guidance document meant to help minimize patient-physician interaction during the pandemic. That guidance includes a list of products and product codes that the agency says can be used for remote-monitoring patients. ()
Many of the products on the FDA’s list originally were not meant to be used to remotely monitor patients, but could be modified for remote monitoring as long as they follow certain agency guidelines, without the need for the sponsor to submit a new premarket application.
The AAMI’s new consensus report defines “remote control” as “the operation of a medical device from a location not co-located with the patient, device or its primary HMI.”
Understanding what’s a remote-controlled device can be tricky. For example, some ventilators have a detachable screen interface on a short cord; such a device would not be considered remote-controlled.
“Some hospitals have figured out how to have that screen just outside a patient’s room, so they don’t have to don and doff PPE [personal protective equipment] before adjusting device settings,” explained Julian Goldman, co-chair of the AAMI’s COVID-19 Response Team. “Is that remote control? Actually, no. It’s still the same device. It hasn’t been modified to add remote-control capability.”
Goldman is an anesthesiologist at Massachusetts General Hospital and medical director of biomedical engineering for the Mass General Brigham health network.
By Shawn M. Schmitt