Just remember to bring all the grand kids when visiting grandma.
Posted on 03/25/2020 11:51:10 AM PDT by Renkluaf
Background & Need
We are one of several teams who recognized the challenges faced by Italian physicians, and are working to find a solution to the anticipated global lack of ventilators. In the US alone, the COVID-19 pandemic may cause ventilator shortages on the order of 300,000-700,000 units (CDC Pandemic Response Plans). These could present on a national scale within weeks, and are already being felt in certain areas. An increase in conventional ventilator production is very likely to fall short and with significant associated cost (paywall warning). Almost every bed in a hospital has a manual resuscitator (Ambu-Bag) nearby, available in the event of a rapid response or code where healthcare workers maintain oxygenation by squeezing the bag. Automating this appears to be the simplest strategy that satisfies the need for low-cost mechanical ventilation, with the ability to be rapidly manufactured in large quantities. However, doing this safely is not trivial. Use of a bag-valve mask (BVM) in emergency situations is not a new concept. A portable ventilator utilizing an ambu-bag was introduced in 2010 by a student team in the MIT class 2.75 Medical Device Design (original paper here and news story here), but did not move past the prototype stage. Around the same time, a team from Stanford developed a lower-cost ventilator for emergency stockpiles and the developing world. It looks similar to a modern ICU ventilator (Onebreath), but “production for US hospitals would start [in] about 11 months”, making it “a second wave solution” (MIT Tech Review Article). Last year, the AMBU® Bag concept was re-visited by two student teams, one from Rice university (here & here), and another Boston-based team who won MIT Sloan’s Healthcare prize (MIT News: Umbilizer). Other teams currently working on this challenge can be found linked on our “Additional Resources” page. Key Research Question We have launched an emergency research project with a team of MIT Engineers and American clinicians to address the question: Is it possible to safely ventilate a COVID-19 patient by automatically actuating a manual resuscitator? Our process in approaching this question is to first identify the minimum requirements for a low-cost ventilator, based on the collective wisdom of many clinicians, design against these requirements, conduct immediate testing, report the results, iterate and facilitate discussion. Manual ventilation with an Ambu-bag is a short-term solution in a critical care environment, without any apparent clinical evidence regarding the safety of long-term use (days-weeks). There are multiple scenarios in which respiratory support could be needed: patients can be awake or asleep, sedated or sedated and paralyzed, breathing spontaneously, weaning off of a vent, etc. Furthermore, changing clinical presentations with ARDS require shifting minute ventilation (tidal volume x respiratory rate) to “lung-protective” strategies, which place patient’s at risk for things like auto-PEEP. Some of these situations are simpler than others, with the simplest being ventilating a sedated, paralyzed patient, and at a minimum a safe emergency ventilator could be used in such a situation to free-up a conventional ventilator. Any solution should be utilized only in a healthcare setting with direct monitoring by a clinical professional. While it cannot replace an FDA-approved ICU ventilator, in terms of functionality, flexibility, and clinical efficacy, the MIT E-Vent is anticipated to have utility in helping free up existing supply or in life-or-death situations when there is no other option. Further, any low-cost ventilator system must take great care regarding providing clinicians with the ability to closely control and monitor tidal volume, inspiratory pressure, bpm, and I/E ratio, and be able to provide additional support in the form of PEEP, PIP monitoring, filtration, and adaptation to individual patient parameters. We recognize, and would like to highlight for anyone seeking to manufacture a low-cost emergency ventilator, that failing to properly consider these factors can result in serious long-term injury or death.
MIT E-Vent Unit 002 Setup, Image by MD
MIT E-Vent Unit 000 Setup, Image by JC Open Source Design At the present time, we are producing four sets of material, which we will be releasing and updating on this site in an open-source fashion: Minimum safe ventilator functionality based on clinical guidance Reference hardware design for meeting minimum clinical requirements Reference control strategies and electronics designs and supporting insights Results from testing in animal models We are releasing this material with the intent to provide those with the ability to make or manufacture ventilators, the tools needed to do so in a manner that seeks to ensure patient safety. Clinicians viewing this site can provide input and expertise and report on their efforts to help their patients. As with any research to design to scale-up to manufacture, we anticipated that there will be many problems and it is our goal to provide this site as a tool to “close the loop” and receive feedback. We will also do our best to publish the most relevant pieces of information in the discussion forum for all to see. We invite anyone who is interested to follow this work. Commenting is moderated and access to comment will be granted based on expertise and quality of comment. This is to ensure that the discussion is constructive and focused on safety. Resources For official information and recommendations on responding to COVID-19 please consult the following resources: World Health Association FEMA CDC Commonwealth of Massachusetts Information on MIT’s internal response and resources can be found here. MIT, along with schools across the nation, has asked all of us to work from home. The crisis has created a unique opportunity to experiment in online / distance education and we are all learning together. Support the fight against COVID-19 If you would like to help the people who are working hard to care for those affected by COVID-19, please consider donating to a reputable organization in your local community. Also we encourage all individuals to please think of your elderly or differently-abled neighbors who may need support. Other options to consider if you would like to help: Nationally, the American Red Cross is soliciting blood donations. The WHO has set up a response fund. Help Support the MIT Team If you would like to help support the all-volunteer MIT team, please consider making a donation. Donations to MIT are tax deductible. We are working long hours, spending fast and, because this project was launched in under a week, we are not a funded research project. You may donate directly below. For large donations, contact the team.
Legal Disclaimer & Copyright The material on this site is provided with no warranties explicit or implied. No material on this site is intended to provide medical advice. All designs are intended for investigational use only. The MIT E-Vent has been submitted to the United States FDA for review under the Emergency Use Authorization (EUA) authority. The Department of Health and Human Services (DHHS) has declared liability immunity for medical countermeasures against COVID-19. This site does not represent any official policies or procedures of the Massachusetts Institute of Technology.
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Latest updates FDA Releases Letter Regarding Ventilators 22 March 2020 FDA released information pertaining to ventilator supply and strategies for healthcare providers, which can be found here: https://www.fda.gov/medical-devices/letters-health-care-providers/ventilator-supply-mitigation-strategies-letter-health-care-providers We are actively processing this information and continue to put the safety of the patient above all else.
The problem isn’t making them, the problem is getting it FDA approved
Just remember to bring all the grand kids when visiting grandma.
Just remember to bring all the grand kids when visiting grandma.
Johnny! I told you not to stomp on that thing!
God help grandma if the kids start listening to dance music.
An outline for an easily-made pressure-regulated ventilator design is on my home page.
Look on my comment pages on this website for a mouth-breathers’ ventilator design.
I will make no patent claims on them.
Problem if you're a smoker.
Hmmm. I thought C-PAP machines could be used in a crunch and there a million of those.
Radio Amateurs Team Up to Help University Design Low-Cost Ventilator
http://www.arrl.org/news/radio-amateurs-team-up-to-help-university-design-low-cost-ventilator
Try an electric air mattress inflator instead of a hair dryer.
Being a CPAP user, I was wondering that myself, particularly for those not having severe breathing problems.
Look, if I am sick enough to need a breathing machine, don’t you think that other medical care and medications, by TRAINED professionals might also be needed?
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Go spend what the real manufacturers spend for approvals.
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