Medical Tech Industry Asks FEMA To Oversee Ventilator Distribution Decisions


On March 24, 2020, CEO Scott Whitaker of AdvaMed medical industry sent a letter to administrator Peter Gaynor at the Federal Emergency Management Agency (FEMA) asking for help distributing ventilators across the United States. The medical device industry advocacy group seeks to ensure that ventilators are being allocated to locations that need them the most.


Ventilator manufacturer production across the United States has rapidly increased since the COVID-19 outbreak to control the number of deaths associated with the virus. The breathing machines provide critical care for those who are severely in need. They can be used to help the patient start breathing on their own again. COVID-19 has notably been more severe and predominant among those with underlying medical conditions over the age of 50. However, reports have shown that even the young and seemingly healthy have fallen victim to the deadly virus. There is a race against time to get ventilators into the hands of those whose patients cannot survive without them.


In his letter, Whitaker stated that AdvaMed manufacturers medical devices that are critical in the diagnosis and treatment of COVID-19, including diagnostic tests and ventilators. He stated that an AdvaMed membership includes major manufacturers of ventilators in the United States, and that their products are reviewed by the Food and Drug Administration for safety and effectiveness. He stated their ventilators are the finest in the world, but they are having a problem meeting the unprecedented demands for them from health care providers all over the world.


Whitaker stated they are having a hard time distributing their products. Specifically, they are having problems allocating the devices to those who need them the most. He stated that many health care centers are trying to buy ventilators. However, some potential purchases should have a higher priority based on the number of patients who need them based on the number of COVID-19 cases in the area. Manufacturer companies do not have the information necessary to establish these priorities and need FEMA’s help deciding where these ventilators should go. Instead of using a first-come-first-serve basis, Whitaker suggested that the ventilators should be distributed to patients in areas where the pandemic is the most life-threatening.


Whitaker stated that these decisions are best handled by a federal corporation that has enough technology to make these critical decisions. He asked FEMA to oversee the allocation decisions with active input of other clinical experts, such as the CDC. Whitaker stated that once these decisions are made, ventilator manufacturers can then commit their supply to the Strategic National Stockpile where they would be distributed wherever FEMA sees fit. Manufacturers would also provide support to help install, service, and train users on how to use their products.


According to an article published in the New England Journal of Medicine, the toughest part about allocating ventilators during a pandemic is determining how to ration them if needed. The United States is not yet facing a shortage of ventilators, according to Robert Truog, a professor of anesthesia and director of Harvard’s Center for Bioethics. Zoll Medical Corporation, which has been producing the preferred ventilator of the U.S. Department of Defense for more than 10 years, is set to make 10,000 ventilators per month in response to the pandemic. This is a 25% increase in volume for the company. Other companies in aerospace, automotive, and information technology industries are also set to contribute to ventilator production.


However, depending on the pace and location of the pandemic’s spread, it may be necessary to ration the ventilators in the future, despite the new sources of production. The authors of the study noted that making the choice to put a patient on a ventilator is truly a life or death decision. It’s necessary to have adequate supplies on hand to save the most lives. This means having ventilators ready before the decision to put a patient on one has to be made. The CDC estimated that nearly 21 million Americans could be hospitalized from the COVID-19 virus.


The authors of the study stated that based on Italy’s experience, we could see 25% of the American population in need of a ventilator at some point during the pandemic. Manufacturers in the United States are racing to produce enough, but as AdvaMed suggests, the majority of ventilators should be sent to buyers with a higher priority than others. FEMA has the information necessary to make these important decisions. This would allow medical industries to focus on production without having to worry about where to allocate their supplies. It also ensures that parts of the country that need ventilators the most would get them.