ANN ARBOR – A portable negative pressure tent developed at Michigan Medicine was recently granted FDA emergency use authorization.
Designed by U-M researchers in collaboration with mechanical systems engineering company FlexSys, Inc., the AerosolVE Tent tent uses a motorized filtration system and a foldable canopy to trap and filter aerosols.
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“The tent helps patients by allowing more liberal use of proven therapies while protecting health care workers and other patients in the process,” assistant professor of emergency medicine at Michigan Medicine who oversaw the tent’s development and testing, Nate Haas, said in a statement. “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.”
Physicians used the tents in clinical testing and successfully performed tracheostomies on three COVID patients who were intubated inside the tent.
Emergency department personnel also successfully treated 20 patients who were either COVID positive or with an unknown status using the tents, including non-invasive ventilation, endotracheal intubations with a 100% success rate on the first pass, high-flow nasal cannula and electrocardiograms.
While the Centers for Disease Control and Prevention requires 12 air exchanges per hour to classify a negative pressure room, the tent can generate up to 600 air exchanges per hour.
“Throughout the testing, the tents were well-tolerated by patients and received positive feedback from health care workers,” Haas said in a statement. “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.”
The FDA has the ability to issue emergency use authorization during a public health emergency for unapproved medical devices to aid in diagnosis, treatment and prevention of conditions if there are no existing approved alternatives on the market.
The tent is licensed to FlexSys, Inc., which formed a Michigan Medicine spinoff company called InspireRx that can bring the product to market.
“We have had requests for this product coming in from hospitals around the country,” CEO of InspireRx and Herrick Professor of Engineering at U-M, Sridhar Kota, said in a statement. “We have partnered with an approved manufacturer with a scalable manufacturing capacity and are ready to begin distribution.”
The team is in discussions with the U.S. Department of Health and Human Services over creating reserves of the tents for pandemics in the future, as well as for countries still seeing critically ill COVID patients in their hospitals.
“Many health systems in the U.S. have very limited negative pressure infrastructure,” CMO of InspireRx and associate professor of emergency medicine at Michigan Medicine, Ben Bassin, said in a statement. ”In most developing countries, it doesn’t 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 or allow for earlier weaning of infected patients from ventilators, enabling them to be returned to the supply chain to help alleviate critical medical equipment shortages.”