Open Source Validation Tests for Open Source COVID-19 Emergency Ventilators
— Robert L. Read, Nariman Poushin, and Juan E. Villacres Perez
Right now, there are over 40 open-source ventilator projects seeking to save lives by providing last-resort ventilators when there are not enough officially approved ventilators. Some are better than others. The biggest gap between where they are today and being able to save lives tomorrow is testing.
In order to give a clinician or medical professional confidence to deploy a pandemic ventilator designed and built quickly, testing is critical. The UK has produced a Rapidly Manufactured Ventilator System (RMVS) specification that clearly sets out what they consider to be the minimal set of features needed to treat a patient with ARDS, the worst complication of COVID-19.
Volunteering for Endcoronavirus.org, we have produced a public repository, COVID-19 Ventilator Validation Tests, that is home to a spreadsheet containing 74 tests. These tests validate that a given ventilator meets the RMVS standard. They cover basic clinical functionality. Equally importantly, they cover basic usability by clinicians familiar with ventilators, ensuring that a new design is understandable even by health care workers on the front lines who are tired and have little time for training.
In this crisis, health officials may have to decide if a new, “last resort”, pandemic model of ventilator can be safely used on COVID-19 patients. These validation tests do not guarantee that, but they are a necessary condition. If it can’t pass these tests, a ventilator is probably not ready to treat COVID-19 patients.
These tests are meant to be used today by the many teams around the world trying to solve the ventilator shortfall disaster by developing and building ventilators. They are a starting point and should be considered a living document that changes over time, like any open source project. You may wish to use them verbatim, you may wish to fork them and add your own fields or tests for your nation or situation. You may wish to use them simply as a reference for authoring your own, or as an entirely independent set of tests not subject to your own bias.
The figure below outlines a multi-team process (scroll down) that we propose would allow health care officials to have confidence in actually deploying last-resort ventilators. These Validation Tests are a critical first step in that process.