Remotely controlled hospital wards may sound like something out of science fiction, but they’re already becoming reality, and an innovation that could save time and even lives during the COVID-19 pandemic.
That’s why the Association for the Advancement of Medical Instrumentation (AAMI) has published a new consensus report (CR) detailing guidelines for the implementation of remote control for many critical medical devices. Notably, the U.S. Food and Drug Administration (FDA) has already issued emergency use authorizations for many remote devices.
AAMI CR511, “Emergency use Guidance for Remote Control of Medical Devices,” is the latest in a suite of consensus reports that represent the combined expertise of clinicians, the medical device industry, and regulators on AAMI’s COVID-19 Response Team.
“We’re following where the greatest need is,” said Dr. Julian Goldman, an anesthesiologist at Massachusetts General Hospital (MGH), medical director of biomedical engineering for the Mass General Brigham health network, and co-chair of the Response Team. “We started when a demand for inexpensive ventilators created what was basically a ‘wild west’ of innovation. Since then, the situation has evolved. We’ve provided emergency design and user guidelines for resuscitators, BiPAP, ventilatory helmets, and now remote-control capabilities.”
“This is the time to innovate,” added Sandy Weininger, co-chair of the Response Team. “The FDA has paved the way for innovation with very low overhead because the clinical need is recognized.”
Weininger is a senior electrical/biomedical engineer at the FDA’s Center for Devices and Radiological Health, which is responsible for the FDA’s regulation of medical devices. In March, the FDA issued a new enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 emergency, followed by emergency use authorizations for certain remote or wearable patient monitoring devices.