Distributed Manufacturing of Open-Source Medical Hardware for Pandemics
* Article: Distributed Manufacturing of Open-Source Medical Hardware for Pandemics. By Joshua Pearce. Prepint, not peer-reviewed.
This article shows both the mobilization and the current immatury of the processes to provide medical hardware in open source formats, but also reviews the solutions such as Good Samaritan legislations to protect makers.
"Distributed digital manufacturing offers a solution to medical supply and technology shortages during pandemics. To prepare for the next pandemic, this study reviews the state-of-the-art for open hardware designs needed in a COVID-19-like pandemic. It evaluates the readiness of the top twenty technologies requested by the Government of India. The results show that the majority of the actual medical products have had some open source development, however, only 15% of the supporting technologies that make the open source device possible are freely available. The results show there is still considerable work needed to provide open source paths for the development of all the medical hardware needed during pandemics.
Five core areas of future work are discussed that include:
i) technical development of a wide-range of open source solutions for all medical supplies and devices,
ii) policies that protect the productivity of laboratories, makerspaces and fabrication facilities during a pandemic, as well as
iii) streamlining the regulatory process,
iv) developing Good-Samaritan laws to protect makers and designers of open medical hardware, as well as to compel those with knowledge that will save lives to share it, and
v) requiring all citizen-funded research to be released with free and open source licenses."
"A recent review of open source ventilators was completed in the midst of the COVID-19 pandemic which found that the peer-reviewed and vetted systems lacked complete documentation and the “open source” ventilator systems that were documented were either atthe very early stages of design (often without a prototype) and lacked testing, or only had basic testing. This is changing rapidly with AmboVent releasing all plans, and there are several projects like the OxyGEN, an automated manual ventilator, being tested that appear to be at onear the point of production for use in hospitals. Many of the designs, particularly in the open sourccommunity, relied on an Arduino, which is an open source microcontroller, but many of the core components have no open source equivalent, such as the valves and methods of producing pressure. Although it should be noted that for this specific technology, there is concern about aerosolizing virus with these systems, and thus they are a potential threat to health-care workers without appropriate safety precautions. Thus, appropriate personal protective equipment (PPE), high-efficiency particulate air (HEPA) and negative pressure rooms can also be considered required associated equipment. There is discussion about CPAP (continuous positive airway pressure) being a better alternative noninvasive treatment. This device is identified as POS/Closed, but, as of this writing, there is significant international development occurring in this space, so this may change rapidly because of the critical nature of ventilators in treating COVID-19 patients."
From the Conclusions
"To prepare for the next pandemic and assist in solving critical shortages for the current COVID-19 pandemic, this study reviewed the readiness of the top twenty technologies requested by the Government of India. The results show that the majority of the actual medical products have had some open source development; however, only a tiny fraction of the supporting technologies were freely available that make the open source device possible. The results show there is still considerable work needed to provide open source paths for the development of all the medical hardware needed during pandemics. The results of this investigation show there are five core areas of future work needed to provide the global community with an ‘open source’ insurance policy of a collection of vetted and tested freely available designs and methods of manufacture for needed medical technology. To enable this potential source of increased security for the world, the technical development of a wide-range of open source solutions for all medical supplies and devices is needed. Policies are needed to protect the productivity of laboratories, makerspaces and fabrication facilities during a pandemic to enable such products to be fabricated when the need arises. These products need to be safe, but there is also a need for streamlining the regulatory process. Lawyers can help as well as technologists by developing Good-Samaritan laws to protect makers, designers and users ofopen medical hardware, as well as to compel those with knowledge that will save lives to share it. Finally, it is 2020 and all of the needed technologies are relatively well-known by scientists and engineers, yet unavailable in the quantities needed. Requiring all citizen-funded research to be released with free and open source licenses in the future will prevent such artificial scarcity from needlessly allowing people to die."