Information and designs for makers of last resource ventilators

This is an open source curated document is intended for makers in Mexico who want to participate in the creation of last resort ventilators to help the medical institutions fight the COVID-19 pandemic. There are not enough ventilators available and thus there will likely be a need for these last resort devices at some point.

Why do you need this document? We have interviewed a number of makers, experts and hospitals about the last resort ventilators and learned from them about what makers should realistically expect. This document is aimed to bring makers up to speed on the current progress of builds in Mexico as well as to provide them with the necessary background information so they will have an idea what they are getting into.

This document is solely intended for those makers who are looking to build last resort, low-cost ventilators to be used in medical institutions in Mexico. The advice here should not be considered as legal or medical advice, but rather a list of information that the reader is responsible to verify themself. The contributors of this project are not doctors, medical researchers nor experienced with law.

How can you help?

This information is open source, so you can present your ideas freely. They will be then curated and added.

Open a pull request with any information you would like to add
- https://github.com/harmittaa/imandst-hackathon-ventilator-docs/pulls
Open an issue to describe your build experiences
- Use the issue template found here: https://github.com/harmittaa/imandst-hackathon-ventilator-docs/issues/1
Open an issue to submit your own design
- Use the issue template found here: https://github.com/harmittaa/imandst-hackathon-ventilator-docs/issues/3
Are you a medical professional?
- All help from medical professionals is very needed. Submit your feedback and ideas here https://github.com/harmittaa/imandst-hackathon-ventilator-docs/issues/1

Background

Why is there a need for ventilators

Of the people who contract COVID-19 virus roughly 5 % percent develop serious or critical symptoms. The patients with these statuses can be in need of ventilator support. This sudden spike has created a tremendous demand for ventilators, as the medical facilities are not equipped for a pandemic the COVID-19. Due to the shortage of mechanical ventilators, the maker community has come together to build last resort emergency ventilators.

Current state of last resort ventilators

The desire to help has created a multitude of different open source emergency ventilator designs, especially those that are aimed for makers to build from locally sourced parts. However, the projects are in varying stages of development, from those with first prototypes just being built to those which have are already in clinical trials.

Selecting a design

Selecting a design to build requires thorough consideration, as malfunctioning of a device could lead to serious injury or even the death of the patient. This document is intended to facilitate that decision making process and to provide up-to-date information on participating to building emergency ventilators. This document addresses low-cost, last resort ventilators that can be built by the makers for use when the existing methods for helping patients have been exhausted.

What to expect

Based on interviews with experts and makers we have compiled the following bullet point list on what to expect:

Don’t expect to get your devices into medical institutions yet, the current regulations do not allow this. Should the pandemic get much worse, there is possibility of the government laxing the regulations. Current interviews with hospitals have shown that hospitals are not willing to use last resort ventilators at this time.
Don’t expect to get your device certified. The process is long, often taking years. This document is aimed for those building last resort ventilators to be used when no other alternative is available.
Don’t expect to receive cooperation from the hospitals. At the time of writing this, the hospitals in Mexico are still able to manage. They will likely not provide you with information regarding their current situation with ventilators or information about what kind of a ventilator should be built.
Your device might kill someone. If the device is not properly calibrated or malfunctions it might lead to serious injury or the death of a patient.
Consider building Class I medical devices. There is a currently a shortage of not only ventilators but, for example, face shields. Building a face shield is a much more simple task and is not going to kill anyone in case of a malfunction.
Give back to the maker community. Share your ideas and experiences, connect with other makers and improve this open source documentation, so others can move faster with their builds
Do you have a contact within the medical community? Share their insights with the rest of the community so everyone can update their approaches based on it.

Regulatory considerations

Medical device classification

The medical ventilators fall under Class II medical devices, meaning that they would require, among other testing, clinical trials before being allowed to be used in hospitals. As the emergency ventilators discussed here are meant to help with acute ventilator shortage, the time frame nor the resources of individual makers, do allow for a full clinical trial to be performed. With this in mind, it is unlikely that, at least at the current state of virus in Mexico, hospitals would take into use any home made ventilators.

So, how do untested devices help?

However, the ventilators discussed here are aimed to be provided as last resort devices for the medical institutions with the most dire needs. Considering the rapid advancement of the pandemic, it is possible that the requirements for the medical ventilators could be laxed and even last resort ventilators could be put into use in hospitals.

Official documentation

The current requirements for emergency ventilators are listed in the above links. Further information regarding the requirements can be found from a number of different governmental sources such as:

The Mexican government has released a document describing the requirements for the ventilator production: Disposiciones para la adquisición y fabricación de ventiladores, durante la emergencia de salud pública por coronavirus 2019. It should be noted that these provisions are only valid during the pandemic.
The Colegio de Ingenieros Biomédicos de México A.C. has also published a set of regulatory requirements for mechanical ventilators available here: Requerimientos regulatorios para la fabricación rápida de ventiladores para atender crisis de COVID-19 Diseño & Desarrollo y Manufactura.
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus
FDA Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories https://www.fda.gov/media/136528/download
Medical Device Compliance Requirements
Rapidly manufactured ventilator system specification

Open source discussion on guidelines

Una open source donde compartimos principalmente para empresas y makers los materiales necesarios para la creación de un ventilador de último recurso próximo a ser aprobado y por si alguna empresa en pausa quiere participar LINEAMIENTOS DE MANUFACTURA Y FABRICACIÓN

Open source designs

The document currently describes two open source designs, Oxygen and E-Vent, both of which are currently being built by makers in Mexico.

Oxygen (https://www.oxygen.protofy.xyz/) features two different versions: the M version intended for makers and the IP version intended for mass production. The latter has passed clinical trials. The downloadable materials are available here: https://www.oxygen.protofy.xyz/download.

MIT E-Vent (https://e-vent.mit.edu/) is a low-cost emergency design developed by a team at the MIT. The materials for the E-Vent are available here: https://e-vent.mit.edu/resources/downloads/.

These two designs are presented as for makers to consider building, the selection was done based on the following criteria.

Validation

How are the designs validated?

The first selection criteria is that the designs have gone through some sort of a validation. Both the E-vent and Oxygen fulfil this criteria. The Oxygen project’s IM model has passed clinical testing in Spain while the E-Vent is has undergone the fourth porcine study. The latter cannot be considered a clinical test, however compared to a plethora of other designs this can be considered to be at an advanced stage.

Price

What does it cost to make?

Second criteria is the price of manufacturing. As the devices are intended to be built by makers with limited resources, the price must be relatively low. Both of the selected projects aim to provide a low-cost, easily producible device.

Community

Why does the community matter?

Third criteria is the community. The importance of the community is especially relevant when makers source materials for their builds. As both of the chosen designs have been developed outside of Mexico, it is important that the local maker community is able to share experiences about materials and the build process.

Comparison of designs and their implementations

Name	Link	Estimated price	Validation	Component availability	Community
Oxygen (IP)	https://www.oxygen.protofy.xyz/	$12,000 MXN	Clinical trials	All components can be sourced from Mexico	https://discord.gg/yyYQxEG & https://www.facebook.com/groups/1347740022075853
MIT E-Vent	https://e-vent.mit.edu/	N/A	Porcine studies	All components can be sourced from the USA	https://e-vent.mit.edu/

Other open source ventilator designs

Public Invention has gathered an exhaustive list on open source ventilator designs which are evaluated on a number of different properties: covid19-vent-list.

Do you want to add your own design?

Please help to improve this documentation by opening an issue or a pull request.

Check out the submitted designs here: designs.

Other considerations about ventilators

Associated Press has written on the April 11th that some hospitals are moving away from using ventilators, due to high death rate of patients who've been placed on ventilators have died.

How to see this content in a different lenguage

Access this webpage bellow (1.) and follow instructions depending on the browser you are using Chrome or Fire fox. For an easy access look for the “Explore this article” section just below the title “How to translate a Web Page” and click on the browser and follow the easy steps.

https://www.wikihow.com/Translate-a-Web-Page#On-Chrome

The following YouTube (2.)link will show you how to change the language of web page step by step.

https://www.youtube.com/watch?v=kevhllFZrk4

Liability and license

This is a project of makers and all information is provided as is, meaning that it might be out of date, incorrect or even dangerous. So, before putting anything you read here to use, do your own research to make sure it's valid. If you find something that is incorrect, please submit a PR. The purpose is to provide a space for makers to share their ideas to help out during the pandemic. The developers do not take any responsibility on the designs added.

MIT License

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.