Robert Read

COVID-19 birthed a movement to use open source to address crises through rapid distributed manufacture of medical supplies and emergency equipment. However, even in drastic crises, labeling, tracking, quality assurance and authenticity is required. The Global Open Source Quality Assurance System (GOSQAS) proposes to solve this with an open provenance tracking system that will track the maker’s mark, self-asserted and 3rd-party quality tests, and changes in custody accessible with a QR code.

About a dozen nonprofits have formed an alliance to promote quality assurance for open source (free-design) devices and supplies. Open source emergency devices and medical supplies can be rapidly manufactured with distributed systems, such as hobbyists with 3D printers. This can quickly repair supply chains broken by war or natural disaster. However, the normal reputational and legal mechanisms for ensuring quality and authenticity don’t function well in such crises.

The open source solution to this is to be as transparent as possible. In the case of physical devices, this means that a would-be buyer of the device should be able to easily look up: when, where, how, and by whom it was made, what quality assurance tests have been performed on it, maintenance performed, etc. By maintaining the complete chain-of-custody, counterfeiting can be effectively mitigated.

Eventually, encryption will allow provenances to be kept appropriately private. This proposed system does not compete with other tracking systems, but can be used to complement them on a purely voluntary basis. Eventually, people will demand full and transparent provenances for many devices.

In this talk we discuss the movement, the problems, and the proposed approach.

Please note that this talk was originally scheduled to be given at 09.40 but have been postponed to give room for the talk Covid Exposure Notification Out in the Open to be longer to cover for cancellations of other talks just before the schedule freeze.

Public Invention is a non-profit that pivoted to human respiration during the pandemic. The PolyVent is a fully free-libre open mechanical ventilator educational platform for teaching and research. It is part of a proposed and partially implemented complete free ecosystem of medical devices for respiration called Freespireco. It runs VentOS free software which can drive any ventilator. These projects represent a burgeoning open source medical device movement.

Free-libre open design hardware grows out of free software. Hardware has greater capital costs than software and is much more expensive to deploy. Medical hardware is more expensive still. Nonetheless, the COVID-19 global pandemic showed that the fragility of our global supply chains kill people. Open source medical hardware is a potential solution to this predictable catastrophe. In coming decades, we hope it will be as common as free software is now.

The PolyVent ventilator was started to address a predicted shortfall in human mechanical invasive and non-invasive ventilators in 2020. This never came to pass in the West, for medical reasons, but it was not a panic—it was a reasonable surmise based on limited data at the time. Over 100 teams tried to create open source ventilators; PolyVent is one of the few still active and fully open.

The PolyVent is completely open and very modular to allow for educational tinkering and graduate-level research. It runs fully open software called VentOS which can drive any electromechanical ventilator based on an extensible hardware driver model. It uses a “super loop” Arduino framework deployed with PlatformIO.

Combined with other modules, such as the VentMon monitor which provides a clinical display in a public data lake and the GPAD (General Purpose Alarm Device), it is an educational platform that has been piloted at one University. Although not for clinical use, we hope for-profit firms will create clinical ventilators based on this design. We understand how to assist such firms in obtaining regulatory approval.

Our hope is that in the next decade, a complete ecosystem of cooperating medical devices, components, data standards, and software, will make safe, reliable, reasonably priced respiratory care available to all people in all nations.