Ventilators for COVID-19 use in Australia

This specification describes the minimal acceptable performance and desired features for a ventilator to be used in Australian hospitals during the current SARS-CoV2 outbreak.

Published

7 April 2020

In response to the anticipated demand for invasive ventilator medical devices to treat patients requiring respiratory support as a result of infection with COVID-19, a Commonwealth Government taskforce has been working to identify domestic manufacturing capability of these devices. Australia's Chief Scientist, Dr Alan Finkel, has led these efforts and, with support from an expert panel of ICU clinicians from across Australia, has compiled Ventilator for COVID-19 use in Australia. This document, published on the TGA's website on 7 April 2020, details minimum technical requirements for invasive ventilators that would be suitable for supply to and use in Australian hospitals when approved devices are not available during the COVID-19 emergency. The specification was prepared in consultation with the TGA and will serve as a guide to domestic manufacturers seeking to support Australia's efforts in managing the COVID-19 emergency.

The specification is expected to be referenced in a new emergency exemption to enable the lawful manufacture and supply of ventilators manufactured in accordance with the specification in Australia.

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