AUTHOR=Rebelo Tiago , Neutel Elizabete , Alves Eurico Castro , Barros Francisco , Oliveira Hélder , Machado Humberto , Mendonça Joana , Araújo João Fortuna , Luís João , Pêgo José M. , Silva José , Oliveira Manuel , Sousa Nuno , Figueiredo Paulo , Barata Pedro , Magalhães Raquel Silva , Magalhães Rui Miguel , Gomes Sara H.
TITLE=ATENA–A Novel Rapidly Manufactured Medical Invasive Ventilator Designed as a Response to the COVID-19 Pandemic: Testing Protocol, Safety, and Performance Validation
JOURNAL=Frontiers in Medicine
VOLUME=8
YEAR=2021
URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.614580
DOI=10.3389/fmed.2021.614580
ISSN=2296-858X
ABSTRACT=Background: The urgent need for mechanical ventilators to support respiratory insufficiency due to SARS-CoV-2 led to a worldwide effort to develop low-cost, easily assembled, and locally manufactured ventilators. The ATENA ventilator project was developed in a community-based approach targeting the development, prototyping, testing, and decentralized manufacturing of a new mechanical ventilator.
Objective: This article aims to demonstrate ATENA's adequate performance and safety for clinical use.
Material: ATENA is a low-cost ventilator that can be rapidly manufactured, easily assembled, and locally produced anywhere in the world. It was developed following the guidelines and requirements provided by European and International Regulatory Authorities (MHRA, ISO 86201) and National Authorities (INFARMED). The device was thoroughly tested using laboratory lung simulators and animal models.
Results: The device meets all the regulatory requirements for pandemic ventilators. Additionally, the pre-clinical experiences demonstrated security and adequate ventilation and oxygenation, in vivo.
Conclusion: The ATENA ventilator had a good performance in required tests in laboratory scenarios and pre-clinical studies. In a pandemic context, ATENA is perfectly suited for safely treating patients in need of mechanical ventilation.