Ventilator-Prototype: Bridge to Mechanical Ventilation (Bridge)
Heads up, I have not been able to update the wiring diagram. The instructions has all the connections in it though. Also, I will update the arduino sketch once I had the time to do a little more testing with the LED and reset/test button.
If anyone has experience with FDA applications for EUA and are able to help with this process, please contact me. I can use all the help I can get.
Disclaimers
- This device is not approved by FDA or any other regulatory body.
- This is not a ventilator or replacement for ventilators.
- This device should never be used on a patient while there is an FDA approved device available.
- Only practitioners who are fully competent in managing critically ill patients should consider this device.
- There is absolutely no clinical testing done on this device. This device should be considered very high risk, and extreme caution should be exercised to consider using this device on a human being. In other workd, the only time the benefit of using this device may outweigh the risks would be when the patient is faced with certain death due to absence of any FDA approved devices or therapies.
- Our team has provided this instruction as good samaritans for everyone and will not accept liability for any damages that the use of this device may cause.
- Anyone who follows this instruction agrees to follow all the loal and federal regulatory protocols for compassionate use of investigational new devices and if applicable inform all the regulatory bodies such as FDA or local IRB.
This is an effort to create a make shift device to bridge patients infected with COVID-19 who need mechanical ventilation only when there is no ventilator available
I am an anesthesiologist with no real technical background. Basically, this is a simple prototype that is easily reproducible and costs about $100. It can be made very quickly and does not require any technical expertise. I started working on this last week, when I heard about the total number of ventilators in my state and the number that we think we're going to need. In the back of my mind, I kept telling myself that we can just use a bag and ventilate the patients with hand, but we are going to have a drastic shortage of man power too. So I decided to make a system that would replace hand ventilation and is cheap, easy and NEVER TO BE USED ON A PATIENT unless shortage of ventilators mean my patient with a reversible respiratory failure is going to die. That is the only time that I would use a system like this. Once I fix my 3D printer's bed, I will post the more elegant prototype. Here I'm using and arduino with DRV 8825 driver for a NEMA 17 stepper motor. I'm working on a few other prototypes too and once I can do more testing, I will post the STL files, arduino sketch and the part list. Again, this is not a ventilator replacement; this is only to be used when patients have no other options and will simply die without a ventilator.
My team is working on the FDA's EUA application and I will provide updates as soon as I can.
Shield:
This work is licensed under a Creative Commons Attribution 4.0 International License.
