An open-sourceventilator is a disaster-situation ventilator made using a freely licensed design, and ideally, freely available components and parts. Designs, components, and parts may be anywhere from completely reverse-engineered or completely new creations, components may be adaptations of various inexpensive existing products, and special hard-to-find and/or expensive parts may be 3D-printed instead of purchased. As of early 2020, the levels of documentation and testing of open-source ventilators was well below scientific and medical-grade standards. One small, early prototype effort was the Pandemic Ventilator created in 2008 during the resurgence of H5N1avian influenza that began in 2003, so named "because it is meant to be used as a ventilator of last resort during a possible avian flu pandemic."
Quality assessment
The policy of using both free and open-source software and open-source hardware theoretically allows community-wide peer-review and correction of bugs and faults in open-source ventilators, which is not available in closed-source hardware development. In early 2020 during the COVID-19 pandemic, a review of open-source ventilators stated that "the tested and peer-reviewed systems lacked complete documentation and the open systems that were documented were either at the very early stages of design... and were essentially only basically tested..." The author speculated that the pandemic would motivate development that would significantly improve the open-source ventilators, and that much work, policies, regulations, and funding would be needed for the open-source ventilators to achieve medical-grade standards.
Design requirements
A number of features are required for an invasive mechanical ventilator to be safely used on a patient:
a way of measuring and controlling the volume pumped and the breath rate to avoid volutrauma;
The FOSS Initiative OpenVentilator.io project began on March 19, after 2 weeks of research.. Jeremias Almadas had posted some drafts he made on the Open Source Covid19 Medical Supplies forum. Marcos Mendez contacted him to join efforts to develop a solution that could be reproduced on a very high scale. This project later became the "OpenVentilator Spartan Model". With the COVID-19 pandemic a new challenge had just arisen, this was no longer to manufacture ventilator, after all, these are manufactured since biblical times, including since 60's models like the Bird MK VII were already consolidated with an enviable engineering that is so simple. The challenge now was to design an item that solves a problem on a global scale. Manufactured on a very large scale and with parts found in small towns and villages. These were the premises assumed by some projects like OpenVentilator.io On March 18, Medtronics had opened its code and files for manufacturing its main pulmonary ventilation equipment ]. The issue was on a scale that Medtronics would not be able to fulfill at the Global level, nor at the regional level. The same was already happening with Philips and G&E and Draguer, world leaders in the manufacture of this type of equipment. It would not make sense to reinvent something that had already been studying for 100 years. The problem was also not an engineering problem, but a logistical and scale problem so that these projects that were to emerge were applicable and achievable. Manufacturing should be decentralized, focused on the regional resources of each individual on planet earth. 9/10 Brazilian cities do not even have an ICU bed, let alone an electronics store and or an Ambu factory. The African situation has already announced a catastrophe Several projects are beginning to emerge in this area, many of them with an engineering approach, many others following strict validations with the regulations. There are few projects that have an , LLC in Whitewater, Wisconsin
Israeli engineers created an open-source ventilator
Disaster-relief provisions
On March 24, 2020, the U.S. Secretary of Health and Human Services enacted Emergency Use Authorizations to allow the use of additional devices, including: "Ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories." This was done in accordance with its February 4 declaration for medical countermeasures against the coronavirus disease 2019, and the equipment is subject to the FDA's "criteria for safety, performance and labeling."
