Prisma Health develops FDA-authorized 3D-printed device that lets a single ventilator treat four patients

The impending shortage of ventilators for U.S. hospitals is likely already a crisis, but will become even more dire as the number grows of patients with COVID-19 that are suffering from severe symptoms and require hospitalization. That’s why a simple piece of hardware newly approved by the FDA for emergency use — and available free via source code and 3D printing for hospitals — might be a key ingredient in helping minimize the strain on front-line response efforts.

 The Prisma Health VESper is a deceptively simple-looking three-way connector that expands use of one ventilator to treat up to four patients simultaneously. The device is made for use with ventilators that comply to existing ISO standard ventilator hardware and tubing, and allows use of filtering equipment to block any possible transmission of viruses and bacteria.

VESper works in device pairs, with one attached to the intake of the ventilator, and another attached to the return. They also can be stacked to allow for treatment of up to four patients at once — provided the patients require the same clinical treatment in terms of oxygenation, including the oxygen mix as well as the air pressure and other factors.

This was devised by Dr. Sarah Farris, an emergency room doctor, who shared the concept with her husband Ryan Farris, a software engineer who developed the initial prototype design for 3D printing. Prisma Health is making the VESper available upon request via its printing specifications, but it should be noted that the emergency use authorization under which the FDA approved its use means that this is only intended effectively as a last-resort measure — for institutions where ventilators approved under established FDA rules have already been exhausted, and no other supply or alternative is available in order to preserve the life of patients.

Devices cleared under FDA Emergency Use Authorization (EUA) like this one are fully understood to be prototypes, and the conditions of their use includes a duty to report the results of how they perform in practice. This data contributes to the ongoing investigation of their effectiveness, and to further development and refinement of their design in order to maximize their safety and efficacy.

In addition to offering the plans for in-house 3D printing, Prisma Health has sourced donations to help print units for healthcare facilities that don’t have access to their own 3D printers. The first batch of these will be funded by a donation from the Sargent Foundation of South Carolina, but Prisma Health is seeking additional donations to fund continued research as well as additional production.

New York will be first state to test treatment of coronavirus with blood from recovered patients

Mike Hixenbaugh
March 24

Hoping to stem the toll of the state’s surging coronavirus outbreak, New York health officials plan to begin collecting plasma from people who have recovered and injecting the antibody-rich fluid into patients still fighting the virus.

Gov. Andrew Cuomo announced the plans during a news briefing Monday. The treatment, known as convalescent plasma, dates back centuries and was used during the flu epidemic of 1918 — in an era before modern vaccines and antiviral drugs.


Some experts say the treatment, although somewhat primitive, might be the best hope for combating the coronavirus until more sophisticated therapies can be developed, which could take several months.


“There have been tests that show when a person is injected with the antibodies, that then stimulates and promotes their immune system against that disease,” Cuomo said. “It’s only a trial. It’s a trial for people who are in serious condition, but the New York State Department of Health has been working on this with some of New York’s best health care agencies, and we think it shows promise, and we’re going to be starting that this week.”

New York has seen a dramatic rise in coronavirus cases in recent days, with about 20,000 confirmed cases and more than 150 deaths as of Monday afternoon, more than in any other state.

State health officials said they expect to get approval from the Food and Drug Administration to begin the plasma trial in the coming days. A spokesman for the FDA confirmed to NBC News that the agency is “working expeditiously to facilitate the development and availability” of convalescent plasma. And at a White House briefing last week, FDA Commissioner Stephen Hahn singled out the treatment as a promising option to fight the disease in the near term.

“That’s great news,” said Dr. Arturo Casadevall, an infectious disease expert at the Johns Hopkins Bloomberg School of Public Health, who has been calling for widespread use of convalescent plasma. “When we started talking about this a few weeks ago, it was just an idea, and now it seems it’s going to become a reality.”


The method — essentially harvesting virus-fighting antibodies from the blood of previously infected patients — dates back more than a century, but it has not been used widely in the United States in decades. Infusions of convalescent plasma were associated with milder symptoms and shorter hospital stays for some patients during the 2002 SARS outbreak, and initial reports from China suggest convalescent plasma might also be effective in dulling the effects of COVID-19, the disease caused by the coronavirus.

The treatment is not without risks. There is danger in giving a patient the wrong type of blood or inadvertently transmitting other pathogens in a transfusion, but safety advancements over the past two decades have made adverse outcomes rare.

In New York, health officials said they plan to begin recruiting patients who have fully recovered from COVID-19 in the coming days. That effort, officials said, would likely start in New Rochelle, the New York City suburb that was the center of the state’s initial outbreak a few weeks ago, because of the concentration of people there who have already recovered.

Potential donors would first need to undergo tests to ensure that they are no longer contagious and to confirm that their blood contains the antibodies needed to fight the disease, state health officials said. After that, donors would go to a local blood bank to give plasma — the liquid part of blood left once cells and platelets have been removed — although the state is still working out logistical details.

New York will begin by offering the treatment only to critically ill patients. But, experts said, once it is proven safe and effective, the treatment will likely work best if given to patients before symptoms become too severe. Casadevall said past studies indicate that proactive infusions of convalescent plasma might also be effective in protecting front-line health care workers from becoming seriously ill.

Similar efforts are underway across the country as hospitals scramble to prepare for an onslaught of critically ill COVID-19 patients, similar to what’s happened in New York and Seattle.

Download the NBC News app for full coverage of the coronavirus outbreak

Doctors from nearly two dozen hospitals have joined the Johns Hopkins-led effort, Casadevall said, including researchers at the Mayo Clinic in Minnesota, the Stanford University Medical Center in California and the Albert Einstein College of Medicine in New York. The researchers have been in contact with the FDA through the weekend, he said, and they hope to launch clinical trials similar to the one in New York in the coming weeks.

Michael Felberbaum, an FDA spokesman, said the agency could not comment on specific COVID-19 clinical trials. But he confirmed that the agency was working to facilitate the use of convalescent plasma.

“The agency is actively engaging with researchers to discuss the possibility of collaboration on the development of a master protocol for the use of convalescent plasma, with the goal of reducing duplicative efforts,” Felberbaum said.

US Military Scientists Hope To Have Coronavirus Therapeutic By Summer

March 10 




A new approach would use RNA or DNA to help the body develop antibodies to the rapidly spreading illness.

A U.S. military research program that seeks a new way to boost a body’s immunity to viruses could change how governments and militaries prepare for pandemics — and might even arrive soon enough to help with the COVID-19 outbreak.

DARPA’s Pandemic Prevention Platform isn’t looking to create a vaccine, which can take years to produce and weeks to take effect in the body. Rather, the goal is to identify the specific monoclonal antibodies that the body naturally produces when it encounters a virus, and then trick the body into producing the one that guards against a specific illness. That could serve as a temporary, months-long shield that can protect the individual from the pathogen until a vaccine can be brought online.

But these antibodies “take a long time to find and discover. There’s a long pipeline in the biomedical world to identify and test them and really understand these antibodies,” said Dr. Amy Jenkins, who manages the program at DARPA.

One of the goals of the program is to accelerate the discovery process.

“We have really trimmed that timeline down from what is usually multiyear timeline to just being a several week timeline,” Jenkins said on Monday. 

It’s a feat they’ve achieved through investments in microfluidics, the manipulation of liquids at the sub-millimeter range; nanofabrication, the fabrication of objects less than a billionth of a meter in size; and new approaches to gene sequencing. 

Jenkins described it this way: “We are able to take a patient that has recovered from this pathogen, for example, and we are able to sequence many of of their B cells. So those cells that make those antibodies that help protect you against those pathogens? We are now able to sequence all of those because of next-generation sequencing approaches.”


But they have very little of the B-cell sample to work from: just one sample from a single individual. If that person’s antibody response was relatively weak, there will be less antibody material to find. “We are relying on that one patient’s immune response. We would typically do this for anywhere between five and ten patients. We have one. So if that one person had a really robust immune response, that’s going to be great. If they didn’t because some people just respond differently, we could be in trouble, because it may be hard to find an antibody. Preliminary data suggests that there may be antibodies present. We are optimistic but also cautious that the antibodies are there,” she said. 

The second goal is to accelerate the delivery of manufactured antibodies. Like vaccines, antibodies are produced in bioreactors, basically a giant, complex cell culture that plays the role of the human body. 

Jenkins and her collaborators are trying to invent a new way to produce antibodies at scale by using the RNA and DNA code of those COVID-19. When that RDA or DNA is injected into a patient, it would begin to work immediately, helping health people ward off the virus and perhaps even functioning to treat sick people as well.

It’s the difference between buying a piece of furniture already assembled versus a mail-order kit with an instruction manual. The hope is that the body will be able to construct the response itself. In essence, said Jenkins, the body becomes the bioreactor. Since RNA and DNA is much easier to produce than a traditional vaccine, the hope is to drastically cut down on the time to manufacture. 

Death toll rises to 22 after powerful tornadoes tear through Tennessee

Brandon Miller and Hollie Silverman, CNN

NASHVILLE, Tenn. (CNN/AP) — Tornadoes ripped across Tennessee early Tuesday, shredding at least 40 buildings and killing at least 22 people. One of the twisters caused severe damage across downtown Nashville, destroying the stained glass in a historic church and leaving hundreds of people homeless.

Daybreak revealed a landscape littered with blown-down walls and roofs, snapped power lines and huge broken trees, leaving city streets in gridlock. Schools, courts, transit lines, an airport and the state Capitol were closed, and some damaged polling stations had to be moved only hours before Super Tuesday voting began.

The death toll jumped to 22 on Tuesday, Tennessee Emergency Management Spokeswoman Maggie Hannan said, after police and fire crews spent hours pulling survivors and bodies from wrecked buildings.

“Last night was a reminder about how fragile life is,” Nashville Mayor John Cooper said at a Tuesday morning news conference.

Tornadoes were reported at least three times along a 145-mile stretch, from the small city of Camden just after 11 p.m. CT, through Nashville after midnight, and into the Cookeville area in Putnam County shortly before 2 a.m., the National Weather Service said.

The Nashville Fire Department is responding to approximately 40 collapsed structures around the city, according to a tweet from the agency.

Officers who specialize in urban search and rescue are being called in, Nashville police said. Rescuers are focusing their efforts in Germantown, East Nashville and Hermitage, according to Joseph Pleasant, spokesman with the Nashville Office of Emergency Management.

About 20 people are in Nashville-area hospitals because of tornado or storm damage in the city, Mayor John Cooper told CNN affiliate WTVF.

“There are a couple of tragic cases, in one case a tree falling on a car and there are also I believe about 20 people in the hospital, so we need to monitor that very carefully,” Cooper said. “We all worry about some people being left in some buildings that have been damaged and I know the first responders are working their way through that problem.”

Police search for injured people in Mt. Juliet

Police in Mt. Juliet, a suburb 20 miles east of Nashville, are searching for injured people. “There are multiple homes damaged and multiple injuries. We have requested mutual aid from allied agencies. We continue to search for injured,” a tweet from the department said.

A shelter has been opened for those displaced by the tornado at the Victory Baptist Church on Tate Lane in Mt. Juliet, according to a tweet.

In Putnam County, there are “several critically injured” people, county Mayor Randy Porter told CNN in a Facebook message. The county suffered damage to several homes and power lines, he said.

DOD makes plans to combat coronavirus

DOD makes plans to combat coronavirus

Kyle Rempfer
March 3, 2020




WASHINGTON — The Defense Department is making plans to combat the coronavirus, DOD leaders said yesterday during a news conference.

For the past six weeks, defense leaders have been meeting to plan for any possible scenario with the virus that first surfaced in China. “We’ve issued a variety of [memoranda] and directives advising the force on how to deal with coronavirus,” Defense Secretary Dr. Mark T. Esper said.

The DOD civilian and military leadership, including all the service secretaries and combatant command commanders, have worked together to ensure the department is ready for short- and long-term scenarios, as well as domestic and international situations. Esper stressed that commanders at all levels have the authority and guidance they need to operate.

“(U.S. Northern Command) remains the global integrator for all DOD efforts and entities,” Esper said. “My number one priority remains to protect our forces and their families; second is to safeguard our mission capabilities and third [is] to support the interagency whole-of-government’s approach. We will continue to take all necessary precautions to ensure that our people are safe and able to continue their very important mission.”

Army Gen. Mark A. Milley, the chairman of the Joint Chiefs of Staff, said the military has existing plans to combat an infectious disease outbreak. The military is executing those plans.

DOD is communicating regularly with operational commanders to assess how the virus might impact our exercises and ongoing operations around the world, the general said. A command post exercise in South Korea has been postponed, but Exercise Cobra Gold in Thailand is continuing.

Milley also said that military research laboratories are working “feverishly” to try to come up with a vaccine.

Commanders are taking all necessary precautions because the virus is unique to every situation and every location, Esper said. “We’re relying on them to make good judgments,” he said. As new issues come up, DOD planners will work with all to combat the spread of the virus.

AI Will Tell Future Medics Who Lives and Dies on the Battlefield

January 24 

SAN ANTONIO—In the warzones of the future, medics touching down amid heavy battlefield casualties will know who to treat first, how to approach every injury, and even who is most likely to live or die — all before looking at a single wounded soldier. 

That’s the vision of Col. (and Dr.) Jerome Buller, who leads the U.S. Army Institute of Surgical Research. 

Buller says biometric data gleaned from soldier-borne sensors, combined with in-depth medical and training data and augmented reality lenses, will help medics in combat evaluate the battlefield and everyone in it from a safe distance. They will make their most important decisions before even seeing their patients.

“Imagine that [the hypothetical future] medic is able to scan the battlefield and instead of seeing rubble, he’s seeing red or green dots, or amber dots, and he knows where to apply resources or not,” Buller said during the Defense One and NextGov Genius Machines event here on Wednesday. 

“Let’s say you and your fellow soldier have the same injury. Looks the same, pools of blood are the same. You may compensate [as in, survive injury] far better than she can, or vice versa. And if I only have two packets of blood, who do I give it to? So this technology will help us to far better use these really scarce resources,” he said. 

That’s a big change from the way battlefield field medicine is performed now, relying heavily on medics’ intuition. “You have to literally determine which ones are going to live and die, so having some type of automated capability from a cognitive perspective to say, ‘Yep, you know they are red, I’m going to go to the next one,’ from a psychological perspective — I think it would have a huge impact on a positive note than just the medic making that call.”

Two Rangers up for valor awards after using new life-saving battlefield blood donor technique

January 24 

The 75th Ranger Regiment is starting to use a new program to administer life-saving warm, fresh blood to wounded troops in dire moments — an innovative program the regiment says could be replicated with other combat units.

Two Rangers who used the technique in combat for the first time last summer are up for valor awards, regiment spokesperson Tracy A. Bailey told Army Times.

By tracking universal blood donors within the regiment, Ranger medics were able to call on volunteers to provide huge quantities of blood in a pinch. The technique was chronicled by the regiment’s public affairs department in a Jan. 13 news release.

It was used in combat last summer in Wardak province, Afghanistan during a helicopter-borne night raid. Two Ranger medics, Staff Sgt. Charles Bowen and Sgt. Ty Able, from Bravo Company, 1st Battalion, managed to save multiple lives that night, according to the 75th Ranger Regiment.

“The valor awards for SSG Bowen and SGT Able are still making their way through the awards board process,” Bailey said. “1st Battalion, 75th Ranger Regiment has an awards ceremony scheduled for March 26. I won’t know until we are closer to this date what awards they will receive for their heroic actions.”

During the summertime raid, the Rangers took AK-47 and PK machine gun fire from a target compound. As they maneuvered on the building, an explosion rocked the soldiers, wounding three.

In the final hours of the Army Ranger’s life, he engaged al-Qaida fighters in close combat but that’s not what killed him.

Bowen and Able then grabbed the wounded Rangers and brought them out of the breach to a safe area. The casualties were hit in the legs and arms, and one had a gaping hole in his chest. The Ranger medics conducted the usual mix of life-saving measures, including applying tourniquets, a needle chest decompression, intravenous lines and administering tranexamic acid, which helps control hemorrhaging.