Business View Magazine | Volume 8, Issue 11

183 BUSINESS VIEW MAGAZINE VOLUME 8, ISSUE 11 of the Medical Device Interoperability & Cybersecurity Program at the Mass General Brigham Health System and member of the AR committee. “Many of us are used to working together. And so, we asked AAMI to leverage existing relationships and help us convene meetings very quickly.” The resulting team was dubbed the AAMI COVID-19 Response Team. With Goldman and Weininger as co-chairs, the committee of well over 100 experts has addressed some of the most pressing device-related concerns for caregivers and regulators during the COVID-19 pandemic. This included emergency design and user guidelines for resuscitators, BiPAP, ventilatory helmets, and even guidance for introducing remote-control capabilities for devices in high-risk patient rooms. In all, the team rapidly produced 10 emergency guidance documents which were made immediately and freely available to the public. These documents are a first-of-their-kind standards resources, called consensus reports (CRs). “CRs are intended to provide a very concise and practical guidance on a really narrow topic,” added Amanda Benedict, vice president of standards, AAMI. “The emergency response CRs are useful for responding to areas where there’s an immediate need for guidance. So, they’re perfect for a public health emergency.” This Isn’t the End Naturally, once the emergency ends, the FDA and other regulating bodies across the world will be lifting their EUAs. Case in point, the FDA has already revoked EUAs for disposable respirators not approved by National Institute of Occupational Safety and Health (NIOSH), as well as some decontamination equipment. Once an EUA is lifted, devices that have not