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.
This information is open source, so you can present your ideas freely. They will be then curated and added.
Based on interviews with experts and makers we have compiled the following bullet point list on what to expect:
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
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
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.
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/ |
Public Invention has gathered an exhaustive list on open source ventilator designs which are evaluated on a number of different properties: covid19-vent-list.
Please help to improve this documentation by opening an issue or a pull request.
Check out the submitted designs here: designs.
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.
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.
The following YouTube (2.)link will show you how to change the language of web page step by step.
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
Copyright (c) 2020 Matti Mäki-Kihniä
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.
https://www.worldometers.info/coronavirus/
https://www.bbc.com/future/article/20200401-covid-19-the-race-to-build-coronavirus-ventilators
https://github.com/PubInv/covid19-vent-list
https://www.nsmedicaldevices.com/analysis/uk-ventilator-regulation-coronavirus/
http://cib.org.mx/Covid19/20200406EspecV1.pdf
https://www.agorize.com/en/challenges/code-life-challenge/pages/guidelines?lang=en