CR511 focuses on highlighting common system elements for engineers and outlining safety and risk control measures that both manufacturers and caretakers should consider. The document also carefully defines what “remote-control” is when referring to medical devices.
For example, some mechanical ventilators are built with a detachable screen interface on a short cord.
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“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 before adjusting device settings,” Goldman explained. “Is that remote control? Actually, no. It’s still the same device. It hasn’t been modified to add remote control capability.”
The document describes a remote-control innovation as an “auxiliary human machine interface” that allows caretakers to operate a medical device “from a location not co-located with the patient, device, or its primary interface.” This even includes the concept of apps for controlling many devices installed on a common platform, such as a secure tablet.
It’s a future for patient-care environments that Goldman has been envisioning for years. As part of a national initiative requested by the White House in 2014, Goldman and his colleagues at the Medical Device Plug and Play Interoperability & Cybersecurity Program at MGH first demonstrated how the remote control of medical devices would be ideal for patient care during an Ebola outbreak.
“We developed a reservoir of knowledge and working prototypes during the 2014 Ebola initiative. For instance, we know that it can take 10 to 15 minutes to put on PPE before going into a patient room. By then, a patient could be in dire straits if they’re waiting for critically important treatment such as turning up the oxygen level on a ventilator or adjusting an infusion pump,” said Goldman. “Fast forward to COVID-19, and now there’s real interest.”
“Now the opportunity is here to apply this knowledge expeditiously,” added Colleen Elliott, director of standards at AAMI. “This consensus report resulted from a collaboration between AAMI’s Interoperability Working Group and our COVID-19 Response Team. We deeply appreciate the subject matter experts and industry leaders who offered their knowledge for the sake of safe and effective medical device innovation.”
AAMI CR511, Emergency Use Guidance for Remote Control of Medical Devices is available for download alongside more than a dozen freely available resources on the AAMI COVID-19 Emergency Guidance web page.
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