Mark Poler, MD, FASA
If ever there were a time to ensure timely and safe access to ventilators, it’s now. That’s behind the longstanding engagement of the FDA Centers for Devices and Radiological Health (CDRH) and members of the Society for Technology in Anesthesia (STA). These collaborations that began long before COVID-19 provided a foundation for rapid response to the pandemic.
The original concept for Saturday’s session “Medical Device Innovation in Anesthesiology: FDA Wants to Help and to Have Your Help!” was to present and discuss the regulatory functions of the FDA as they interact with innovation and advancing anesthesiology practice. The first part of the session will continue to be devoted to the ordinary functions of the FDA.
How the pandemic affected urgent response is the second “current events” focus of the session. Mark Poler, MD, FASA, of Geisinger Medical in Danville, Pennsylvania, will moderate the session, which spotlights anesthesiology’s role in continuing to shape the future of high-quality and innovative emergency medical devices.
“The second half of the session will plunge right into the pandemic response to the ventilator shortage, the use of split-circuit or multiplex ventilation for two patients, and lessons learned from a project developing an inexpensive, rapidly manufacturable ventilator,” Dr. Poler said. “Unfortunately, most pandemics go on for two or three years. We’re okay for now, but if we see another surge, we might be a little better prepared.”
Featured Session: Medical Device Innovation in Anesthesiology: FDA Wants to Help and to Have Your Help!
3-4 p.m. CT
Saturday, October 3
According to Dr. Poler, the use of stand-alone hardware and software devices is on the rise as part of an integrated approach. Not surprisingly, anesthesiology has produced many innovations over the course of its history and is critical to advancing products into the future. During the session, a panel of experts will address how the FDA regulates the development of new products, while supporting safety and innovation.
As part of the discussion on pandemic response, Dr. Poler said the session will focus on how to select patients and employ split-circuit or multiplex ventilation as an emergency intervention. Common concerns arising from this approach include differing lung compliance and oxygen uptake impairment per patient.
“Cross contamination is less of a concern when both patients are likely to have the same infectious agent. It can be dangerous for two patients if you can’t provide the balance you need to serve two patients who are fairly well matched,” Dr. Poler said.
Because of the shortage of ventilators in some places during the height of the pandemic, widely usable medical device innovations are needed. One approach is mechanical self-inflating resuscitator “AMBU squeezers,” an alternative to prolonged manual ventilation. According to Dr. Poler, these basic ventilators are inexpensive to manufacture and easy to reproduce quickly – possibly even in third-world countries.
Is another surge of the same magnitude expected this fall and winter? Perhaps, Dr. Poler said. However, innovations, such as squeezers, can benefit the masses. India, he said, is currently having more new COVID-19 cases per day than any other nation. Sudan has only 80 ventilators in the whole country.
“We cannot assume that it’s over. We need to push for innovation,” Dr. Poler said. “The squeezers are a decent little ventilator and an engineer in Sudan could adapt local materials to make them.”
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