With new FDA guidance and an Emergency Use Authorization, and support from stakeholders such as ResMed and Syneos Health, the use of noninvasive or invasive bilevel positive airway pressure devices is encouraged in appropriate COVID-19 patients as an emergency solution to the mechanical ventilator shortage.
The COVID-19 pandemic has placed the ingenuity and adaptability of the medical device manufacturing and regulatory community front and center. Healthcare providers the world over are working tirelessly, and under previously unimaginable circumstances, to use any and all tools at their disposal to save lives. In the US, FDA has been easing the regulatory barriers to allow them to do so, via new guidance and an emergency use authorization (EUA) intended to address the current and anticipated shortage of mechanical ventilators in some of the hardest-hit regions. Emphasis is now being placed on optimizing ventilator use, including ensuring the availability of alternatives such as repurposed anesthesia and bilevel positive airway pressure machines—the latter delivering alternating inhalation and exhalation pressures and typically used in obstructive sleep apnea. These actions could help to conserve ICU beds and mechanical ventilation equipment for critically ill COVID-19 cases, and reduce the risk of long-term cognitive and physical effects of heavy sedation and intubation while on mechanical ventilation, especially for elderly patients.
Market Pathways spoke with Carlos M. Nunez, MD, Chief Medical Officer of ResMed Inc., a leading global sleep and respiratory device maker, as the company faces this pandemic head-on. Nunez talked about his close, ongoing discussions with FDA that have helped propel recent guidelines and EUAs for leveraging bilevel machines to treat life-threatening COVID-19 respiratory complications, as ResMed has maximized the production of devices.