AAMI

gone through the proper pre-COVID approval channels will no longer be allowed to be used or sold. And yet, those who followed the emergency CRs may have an edge as they consult established standards and seek regulatory approval. That’s because, in following the ten CRs, manufacturers and caregivers have already been exposed to a refined sampling of what is the state-of- the-art for the safe (and potentially regulator compliant) development and use of medical devices. To write these CRs, “we’ve leveraged existing device standards while narrowing the scope, slicing up the apple and only taking the immediately useful parts,” Weininger explained. COVID Response Team member Bob Kopotic, senior manager of clinical and medical affairs for critical care at Edwards Lifesciences, added that the communal effort put into creating these CRs also created a culture of information sharing rarely seen in the medical device field. “It was tremendous to see the number of otherwise competitor ventilator companies come together in a very collegial way, “he said. Contributing manufacturers “realized that they are in some way supporting use of devices where otherwise their own device would be in place,” and yet, it didn’t seem to matter. “I see these people passionate about patients, and that, I think, really was the drive.” The New York Stock Exchange thanked Samantha Moriarty, a bio- medical equipment technician for GE Healthcare in Melrose, MA, for ensuring ventilators at hospitals are operating safely.