Effective November 27 (2020), the ARM team is suspending any sales or distribution of the current version of the ARM.
Review of clinical trial data that became available to the team on November 26 shows that the ARM device is not as effective at reducing leak and aerosolization as earlier data had suggested. The complete data and analysis report will be posted on the public project repository at https://github.com/GliaX/Aerosol-Reducing-Mask.
The clinical trial was not a requirement for regulatory approval from Health Canada and the device is still approved under an Interim Order. However the trial data suggests that while safe and effective at providing respiratory support, the device fails to meets its primary indication (protection of health care providers and other patients from infectious aerosols), and so we are withholding all sales and deployments of the device. We are currently undertaking a detailed analysis of the device and causes of failure in order to create a road map for required modifications for a subsequent version. Such modifications and the necessary testing will likely not be completed in sufficient time to meet current urgent needs. All analysis reports and other documents will continue to be posted on the public repository.
Why the aerosol-reducing mask?
The Aerosol-Reducing Non-Invasive Ventilation Mask is intended to be worn by hospital patients in respiratory distress. It has a universal 3D printed adapter that allows it to be attached to any existing commercial BiPAP or CPAP machine.
The device functions similar to existing masks, but has the advantage of significantly reducing aerosolization – the process by which virus droplets are emitted into the air. Healthcare workers have long been at risk of virus exposure with BiPAP and CPAP patients, a risk that has been compounded by the ongoing COVID-19 pandemic.
Using off-the-shelf devices and 3D printing technology, our Aerosol-Reducing Mask is poised to transform the standard of respiratory care by nearly eliminating risk of aerosolization.
Traditional masks for BiPAP and CPAP machines leak air at high pressures; as that air can contain virus particles, it can cause infection of anyone within the vicinity of that patient. To address this problem, we’ve combined readily available facepieces that have a double seal – one around the mouth and nose, and another around the face – with open source 3D printed adapters to create a high quality device that leaks less air. The Aerosol-Reducing Mask is produced by Glia as a Health Canada-approved Class II medical device.
The Aerosol-reducing Mask can be used any time infection control is a concern, including with patients who may be at risk of an aerosol-borne disease such as COVID-19, influenza, or other viruses.
The Aerosol-Reducing Mask has been extensively tested and is ready for use in emergency rooms, intensive care units, pre-hospital transport, intra- and inter-hospital transport, and for emergency use in remote health stations without access to assisted ventilation systems. It comes in multiple sizes to ensure proper fit, and includes a large visor for patient comfort and visibility.
The most recent version of the plans for the Aerosol-Reducing mask can be found on our GitHub.