FAQ
Thank you for all of your emails. We do apologize if we couldn’t respond to you individually or are late in our response. We’re simply overwhelmed with the flood of emails and requests. We hope the following statements would answer most if not all of your questions.
Q: What is the design philosophy behind this ventilator?
As a device that will be used to support patients, performance and safety are the foremost considerations. To address the ongoing pandemic, we have selected parts that do not and will not likely have supply shortage.
The ventilator is designed with modularity as a principal. In this manner, different components can be incorporated without re-engineering a full system. The ability to use different parts is of vital importance as parts available are not homogeneous spatially and temporally. The other significant design principle is openness. Our design is completely open to anybody wishing to build it and use it for medical purposes, with the only restriction to observe the permissive license agreement.
A major goal of our project - beyond the development of the safe and effective ventilator itself - is the improvement and sharing of a resilient, comprehensive open-source framework and design process for reliable medical devices that can be adopted readily within regional groups and communities, empowering them to respond locally by creating their own critical healthcare equipment. Towards that end and to distribute and make all our reference designs accessible, we will iteratively design “ventilator component kits” and design tools, which will allow engaged partners to replicate and localize the reference design rapidly. These starter kits will be evaluated further for both invasive and non-invasive modes.
Q: What ventilation modes does it support?
VC-AC, PC-AC, VC-SIMV, PC-SIMV, PSV/CPAP. Adaptive modes will be added
Q: Who can manufacture and engage with the project?
Anybody in the world can manufacture parts for the Pufferfish, or the whole system. However, international manufacturers should abide by the terms of Permissive license (currently) and the open source license we will continue to release the work under. Furthermore, manufacturers must comply to their local health regulatory requirements and strictly observe the permissive license agreement.
Q: Where are the partners from?
The core of the team is comprised of academics from Brown University, Stanford University and University of Utah, while a very broad range of industrial partners are also engaged. Our team is composed of both engineers, designers and clinicians - both national and international - giving us a handle on building tools relevant for COVID19 context. We look forward to engaging with broader number of clinicians, distribution and regulatory organizations globally.
To enable global adoption, we have chosen to release all our work under “Apache + Solderpad Hardware License” enabling organizations to build upon our work.
Q: Is this FDA approved?
Pufferfish is not a FDA approved product as yet. We have initiated the FDA EUA interactive process and expect to be fully approved. We are further pursuing approvals with local regulatory bodies globally.
Q: Why are you not using automated bag squeezing based approaches?
Instead of an automated resuscitator, we’d like to provide a solution that offers treatment options ranging from High Flow Nasal Cannula to invasive mechanical ventilation and can be used for the entire duration of respiratory support for a COVID19 patient, be it a few hours or few weeks.
Q: How much does it cost?
The cost of the parts to build the ventilator is approximately 600-700 USD.
Q: Can it operate without compressed air?
Pufferfish can operate with wall air or utilizing an oil-free compressors that are widely available. We are just starting work on a blower-based options as well. With the modularity of the system, we expect to have the proof of concept of the system operating with oxygen line or cylinder only while delivering the same performance soon.
Q: What is the permissive license?
We are currently sharing all our work under “permissive license”
Permissive license: gives "preview access" to our work-in-progress before we release our work to the general public under an open-source license. Permissive license will act as a temporary measure allowing us to share our development work earlier than we would under an open-source license.
Note that the term "permissive" in this license is to be understood in the original sense: we are granting permissions to do things with our work which we are not legally obligated to grant. However, this license is not "permissive" in the open-source sense of the term "permissive", but rather is a strongly reciprocal/"copyleft" license with a time limitation and a scope limitation on permitted uses.
Open-source licenses: We will be using Apache + Solderpad Hardware License for releasing our work to the public, when we feel that work is mature enough for public collaboration and review. For partners that would like to engage - our work is available under the permissive license described above.
Please reach out to us at pezglobo.pufferfish@gmail.com for further discussions.