April 8, 2020
The COVID-19 health crisis is causing a surge in patients with impaired lung function at emergency departments and intensive care units around the world . The Vecna family of companies – including Vecna Healthcare, Vecna Robotics, and nonprofit arm VecnaCares – is teaming up with MIT CSAIL, 10XBeta, and others to develop and bring to market an automated manual resuscitator for use in emergency overflow. The device, called Ventiv, is an automated manual resuscitator compressor. Ventiv can be used in conjunction with Ambu bags or all other self-inflating bags available off the shelf. Ventiv provides continuous pressure ventilation by automating the compression and relaxation of manual bags.
Due to the numbers of patients currently being treated for impaired lung function brought on by COVID-19, traditional ventilators are in short supply. Ambu bags, generically known as manual resuscitators or “self-inflating bags”, are hand-held devices used to provide positive pressure ventilation to patients who are not breathing adequately. Manual resuscitators are commonly found in ambulances and on crash carts in healthcare environments. However, they require a medical professional to be present and constantly applying compression to provide the patient with the right amount of breath.
To alleviate the medical professional from providing manual breathing support, the Ventiv is designed to hold a manual resuscitator and provide a steady stream of breathing assistance to the patient. The clinician uses an analog control module to set how frequently to compress the bag, and the volume that should be deployed with each breath for hands-free operation.
The Ventiv program has been designed to provide hospitals and health systems a low-cost automatic ventilator for emergency overflow. The price is currently set at $950.
Power Source: 110/240 V, 12V battery, CliniPAK power management
Control: Set respirations/minute, pressure delivery, pediatric or adult, calibrate to multiple brands of manual ventilator bags, personalized per patient device
Safety: Safety alarms for loss of pressure, disconnection, and mechanism malfunction. Easy release of bag for manual ventilation control.
Data & Analytics: Track use and events to patient record and aggregate clinical and performance data across units
Vecna Healthcare has applied for the Emergency Use Authorization (EUA) from the FDA which allows them the ability to manufacture and distribute product with an accelerated certification process. Vecna Robotics is coordinating manufacturing groups that have come forward to offer priority status in their queues and access to suppliers for a truly low cost option for meeting the need for ventilators with the goal to manufacture in the tens of thousands. VecnaCares is reaching out to first world hospitals and treatment centers while also responding to RFPs for healthcare providers Africa and low resource places around the world. VecnaCares will use OpenMRS and CliniPAK in those instances to improve data and reporting on both the individual and aggregate level.
Once units are out in the field, Vecna Healthcare will continue to support them and gather data and feedback that can go back to the community and contribute towards a full 510K status with the FDA.
“We are standing on the shoulders of giants. It’s inspiring to see how the team at MIT and our partners have pulled together to create an optimized design. Designers, business owners, and regular people are asking how can I help? We have mobilized as a community to create an open project for everyone to contribute and make the difference,” says Vecna Healthcare Founder and CEO Deborah Theobald says. “We are guiding them as quickly as possible to the production line and mass distribution.”
According to Theobald, the short term goal is to deliver a product that alleviates healthcare team stress and patient suffering. “That is where we are focused through the end of May when all the US states are forecasted to have peaked. We anticipate a lot of lessons learned through that process. And then we hope that those lessons will be helpful to other parts of the world who are heading into winter with COVID-19 and live with much lighter safety nets around them,” said Theobald, who founded the VecnaCares Charitable Trust in 2006 to bring ruggedized healthcare IT to remote and underserved communities worldwide. “We need to be ready, and whatever lessons we can share with other people who are working with the open source design or want to tap into the benefits of global supply chains or leverage our EUA, my goal is to make that available.”
The Vecna family of companies also responded to the Ebola epidemic in 2014 by sending telepresence robots and the CliniPAK ruggedized electronic medical record for use in temporary Ebola Treatment Units across West Africa.