Business View Magazine | Volume 8, Issue 11

182 BUSINESS VIEW MAGAZINE VOLUME 8, ISSUE 11 representatives from AAMI Standards join crucial discussions with other international standards developers in global committees. When the COVID-19 pandemic created an unprecedent need for the fast development of new devices and maintenance practices under FDA Emergency Use Authorization (EUA), companies and amateur engineers alike hastened to invent inexpensive solutions for COVID-19 patient care. Unfortunately, when hospitals are filling, there’s no time to develop new standards for emergency-use devices. Nor were some well- meaning companies aware of the existing standards for medical devices. “Early in the pandemic, there was uncertainty,” said Sandy Weininger, senior engineer at the FDA’s Center for Devices and Radiological Health and member of AAMI’s Anesthetic and Respiratory Equipment (AR) committee. “You had this perfect storm of scarcity of parts, testers who aren’t in labs, and device constructors trying to innovate in spaces they’re not entirely familiar with.” “We weren’t really sure at that time what problems were going to surface or how clinical practice might have to change abruptly,” added Julian Goldman, anesthesiologist, medical director of biomedical engineering, director An example of a ventilatory assistance helmet already in production for emergency use in Italy. Non Invasive Ventilation Helmet. DIMAR S.r.l. – Medolla – Italy