Open Source = Global Relevance
The team behind CoRESCUE AAU Pandemic Ventilator has a clear focus: to make an easy to build, affordable, and simple to operate emergency ventilator freely available for all, in quantities that can make a difference in the fight against COVID-19. For health care providers, we hope that this will prevent you from facing difficult medical prioritization issues.
Why create an Open Source ventilator?
Our research at Aalborg University has resulted in a prototype emergency ventilator. Due to the emergency caused by the COVID-19 pandemic, Aalborg University has decided to make all information and materials for this prototype emergency ventilator available to the public under a permissive open source license.
The emergency ventilator has been approved by the Danish Medicines Agency to be exempt from CE marking requirements for use in the current COVID-19 crisis.
For you as a health care provider it means
• The AAU Pandemic Ventilator is a last resort and should only be used in situations where no other alternatives exist, as the patient would otherwise die if a ventilator is not available.
• The AAU Pandemic Ventilator is not approved as a medical device. The exemption from CE marking requirements is valid in Denmark. If you reside outside Denmark, you must seek approval from your local authorities for its use. We hope that our regulatory application [ VENT-20-001-DOC Ansoegningsskema] may serve as an inspiration and help when you seek approval.
• The AAU Pandemic Ventilator is not produced by a single corporate entity that assumes the normal legal obligations for placing it on the market. We aim to facilitate production of the AAU Pandemic Ventilator by local manufacturers. Each of these assumes total ownership of our design and is free to choose how they make the ventilators available and under which responsibility. We aim to list local manufacturers of the AAU Pandemic Ventilator as they become available.
For you as a manufacturer it means:
• The permissive open source license implies that anyone can modify and build the AAU Pandemic Ventilator. However, by doing so you also accept all legal responsibility for making the AAU Pandemic Ventilator available.
• When you download, clone, or fork the materials provided on Github for the AAU Pandemic Ventilator this action is an accept of its license.
• If you modify, transform, improve or build upon the AAU Pandemic Ventilator, you are obligated to make your modifications available under a license that includes terms and conditions of use identical to the terms and conditions of use of the AAU Pandemic Ventilator.
• You are encouraged to let us know of your effort to build the AAU Pandemic Ventilator so we can make this information available to those in need. We will greatly appreciate your contribution to helping health care providers fighting the COVID-19 pandemic.
MATERIALS Available
The information and materials made available by Aalborg University (the ‘Disclosed Materials) include:
1. Reference implementations of the AAU Pandemic Ventilator
2. Our application and approval from the Danish ministry (for inspiration to write your own approval documents). This includes test strategies, user manuals, risk analysis, etc. This is provided in Design History File
The Materials are made available by Aalborg University subject to specific terms and conditions of use found here.
By downloading, cloning, or forking the content of the Disclosed Materials you will implicitly be acknowledging that you have read and accepted these specific terms and conditions of use.
