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.
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“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. The rationale is straightforward: if a device or application can reduce how often healthcare providers need to be in the same room as their COVID-19 patients, it will be harder for the SARS-CoV-2 virus to spread. However, what remained unclear to device developers was where to begin.
“Early in the pandemic, there was uncertainty,” said Weininger. “You had this perfect storm of scarcity of parts, testers who aren’t in labs, and constructors trying to innovate in spaces they’re not entirely familiar with. So, we’ve leveraged existing device standards while narrowing the scope, slicing up the apple and only taking the immediately useful parts.”