FDA authorized emergency use of portable negative pressure tent – State of Reform – State of Reform

The Food and Drug Administration (FDA) granted emergency use Wednesday to newly designed negative pressure tents made by Michigan Medicine in response to the COVID-19 pandemic. Michigan Medicine is in talks with the U.S. Department of Health and Human Services to stockpile these tents for the next pandemic and assist countries that still have high rates of COVID cases and deaths.

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The tent, AerosolVE Tent, uses a clear, foldable canopy that can be applied anywhere with a motorized filtration system that filters and contains aerosols. The device was developed by the Michigan Center for Integrative Research in Critical Care (MCIRCC) in collaboration with FlexSys, Inc., a Michigan-based mechanical systems engineering company.

Nate Haas, M.D., assistant professor of emergency medicine at Michigan Medicine and one of the leaders of the tents testing and development, said:

The tent helps patients by allowing more liberal use of proven therapies while protecting health care workers and other patients in the process. The device can turn any hospital bed, stretcher or operating room into a portable negative pressure room. The light weight, collapsibility and inexpensive materials also make it ideal for use in non-traditional settings such as field hospitals.

Clinical testing saw early success. Tested tents generated up to 600 air exchanges per hour, when the Centers for Disease Control (CDC) requirement for a negative pressure room is only 12. The device has been used on 20 known positive COVID patients or unknown-COVID-status patients in the emergency room. The device saw a 100% first-pass success among these patients for endotracheal intubations.

Haas said:

Throughout the testing, the tents were well-tolerated by patients and received positive feedback from health care workers. The patients were able to easily communicate with their providers and family members, and no serious adverse events occurred. I am excited about the potential of these devices to help more patients and health care workers at other institutions moving forward.

After emergency authorization, the device is eligible to be brought to market by InspireRx, a company formed by FlexSys Inc. and Michigan Medicine spinoff company. Ben Bassin, M.D., CMO of InspireRx and also an associate professor of emergency medicine at Michigan medicine, said:

Many health systems in the U.S. have very limited negative pressure infrastructure. In most developing countries, it doesnt even exist. We think [the AerosolVE Tent] is a scalable solution with great utility that can also allow the provision of early non-invasive respiratory therapies as well as life-saving procedures. This could possibly alleviate the need for a ventilator, enabling them to be returned to the supply chain to help alleviate critical medical equipment shortages.

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FDA authorized emergency use of portable negative pressure tent - State of Reform - State of Reform