Clinical and design considerations will be published online; goal is to support rapid scale-up of device production to alleviate hospital shortages.
One of the most pressing shortages facing hospitals during the Covid-19 emergency is a lack of ventilators. These machines can keep patients breathing when they no longer can on their own, and they can cost around $30,000 each. Now, a rapidly assembled volunteer team of engineers, physicians, computer scientists, and others, centered at MIT, is working to implement a safe, inexpensive alternative for emergency use, which could be built quickly around the world.
The team, called MIT E-Vent (for emergency ventilator), was formed on March 12 in response to the rapid spread of the Covid-19 pandemic. Its members were brought together by the exhortations of doctors, friends, and a sudden flood of mail referencing a project done a decade ago in the MIT class 2.75 (Medical Device Design). Students working in consultation with local physicians designed a simple ventilator device that could be built with about $100 worth of parts. They published a paper detailing their design and testing, but the work ended at that point. Now, with a significant global need looming, a new team, linked to that course, has resumed the project at a highly accelerated pace.
The key to the simple, inexpensive ventilator alternative is a hand-operated plastic pouch called a bag-valve resuscitator, or Ambu bag, which hospitals already have on hand in large quantities. These are designed to be operated by hand, by a medical professional or emergency technician, to provide breaths to a patient in situations like cardiac arrest, until an intervention such as a ventilator becomes available. A tube is inserted into the patient’s airway, as with a hospital ventilator, but then the pumping of air into the lungs is done by squeezing and releasing the flexible pouch. This is a task for skilled personnel, trained in how to evaluate the patient and adjust the timing and pressure of the pumping accordingly.
The innovation begun by the earlier MIT class, and now being rapidly refined and tested by the new team, was to devise a mechanical system to do the squeezing and releasing of the Ambu bag, since this is not something that a person could be expected to do for any extended period. But it is crucial for such a system to not damage the bag and to be controllable, so that the amount of air and pressures being delivered can be tailored to the particular patient. The device must be very reliable, since an unexpected failure of the device could be fatal, but as designed by the MIT team, the bag can be immediately operated manually.
The team is particularly concerned about the potential for well-meaning but inexperienced do-it-yourselfers to try to reproduce such a system without the necessary clinical knowledge or expertise with hardware that can operate for days; around 1 million cycles would be required to support a ventilated patient over a two-week period. Furthermore, it requires code that is fault-tolerant, since ventilators are precision devices that perform a life-critical function. To help curtail the spread of misinformation or poorly-thought-out advice, the team has added to their website verified information resources on the clinical use of ventilators and the requirements for training and monitoring in using such systems. All of this information is freely available at e-vent.mit.edu.
“We are releasing design guidance (clinical, mechanical, electrical/controls, testing) on a rolling basis as it is developed and documented,” one team member says. “We encourage capable clinical-engineering teams to work with their local resources, while following the main specs and safety information, and we welcome any input other teams may have.”
The researchers emphasize that this is not a project for typical do-it-yourselfers to undertake, since it requires specialized understanding of the clinical-technical interface, and the ability to work in consideration of strict U.S. Food and Drug Administration specifications and guidelines.
Such devices “have to be manufactured according to FDA requirements, and should only be utilized under the supervision of a clinician,” a team member said. “The Department of Health and Human Services released a notice stating that all medical interventions related to Covid-19 are no longer subject to liability, but that does not change our burden of care.” he said. “At present, we are awaiting FDA feedback” about the project. “Ultimately, our intent is to seek FDA approval. That process takes time, however.”